20.11.2018 Kit components Product code Description A097 ......Printing date 20.11.2018 Revision: 03.11.2016 Trade name: hCG beta standards A-F (Contd. of page 5) 48.0.4 IMDG: International

Kit components20.11.2018

Product code Description

A097-101 DELFIA Free hCGβ

Components:13804353 hCG beta standards A-F13802696 Anti-hCGβ-Sm tracer13802700 DELFIA-2 BufferB117-100 DELFIA/AutoDELFIA Wash ConcentrateB118-100 DELFIA /AutoDELFIA Enhancement Solution

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according to 1907/2006/EC, Article 31Printing date 20.11.2018 Revision: 03.11.2016

48.0.4

* SECTION 1: Identification of the substance/mixture and of the company/undertaking

ꞏ 1.1 Product identifier

ꞏ Trade name: hCG beta standards A-F

ꞏ Article number: 13804353ꞏ 1.2 Relevant identified uses of the substance or mixture and uses advised against

No further relevant information available.ꞏ Application of the substance / the mixture

In vitro diagnosticsLaboratory chemicals

ꞏ 1.3 Details of the supplier of the safety data sheetꞏ Manufacturer/Supplier:

PerkinElmerWallac OyP.O. Box 10FI-20101 TurkuFinland

ꞏ Further information obtainable from:Product safety [email protected]ꞏ 1.4 Emergency telephone number:

CHEMTREC (whithin U.S.) 800 424-9300CHEMTREC (from outside U.S.) +1-703-572-3887

* SECTION 2: Hazards identification

ꞏ 2.1 Classification of the substance or mixtureꞏ Classification according to Regulation (EC) No 1272/2008

Aquatic Chronic 3 H412 Harmful to aquatic life with long lasting effects.

ꞏ 2.2 Label elements

ꞏ Labelling according to Regulation (EC) No 1272/2008 and 98/79The product is labelled according to the IVD regulationThe product is classified and labelled according to the CLP regulation.ꞏ Hazard pictograms Voidꞏ Signal word Voidꞏ Hazard statements

H412 Harmful to aquatic life with long lasting effects.ꞏ Precautionary statements

P273 Avoid release to the environment.P501 Dispose of contents/container in accordance with local/regional/national/international regulations.ꞏ 2.3 Other hazardsꞏ Results of PBT and vPvB assessmentꞏ PBT: Not applicable.ꞏ vPvB: Not applicable.

SECTION 3: Composition/information on ingredients

ꞏ 3.2 Chemical characterisation: Mixturesꞏ Description: Mixture of substances listed below with nonhazardous additions.ꞏ Dangerous components:

CAS: 26628-22-8EINECS: 247-852-1Index number: 011-004-00-7

sodium azide Acute Tox. 2, H300; Acute Tox. 1, H310; Aquatic Acute 1, H400;

Aquatic Chronic 1, H410

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Trade name: hCG beta standards A-F

(Contd. of page 1)

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* SECTION 4: First aid measures

ꞏ 4.1 Description of first aid measuresꞏ After inhalation: Supply fresh air; consult doctor in case of complaints.ꞏ After skin contact: Generally the product does not irritate the skin.ꞏ After eye contact: Rinse opened eye for several minutes under running water.ꞏ After swallowing: If symptoms persist consult doctor.ꞏ 4.2 Most important symptoms and effects, both acute and delayed No further relevant information available.ꞏ 4.3 Indication of any immediate medical attention and special treatment needed

No further relevant information available.

SECTION 5: Firefighting measures

ꞏ 5.1 Extinguishing mediaꞏ Suitable extinguishing agents: Use fire extinguishing methods suitable to surrounding conditions.ꞏ 5.2 Special hazards arising from the substance or mixture No further relevant information available.ꞏ 5.3 Advice for firefightersꞏ Protective equipment: No special measures required.

* SECTION 6: Accidental release measures

ꞏ 6.1 Personal precautions, protective equipment and emergency procedures Not required.ꞏ 6.2 Environmental precautions:

Inform respective authorities in case of seepage into water course or sewage system.ꞏ 6.3 Methods and material for containment and cleaning up:

Dispose contaminated material as waste according to item 13.ꞏ 6.4 Reference to other sections

See Section 7 for information on safe handling.See Section 8 for information on personal protection equipment.See Section 13 for disposal information.

* SECTION 7: Handling and storage

ꞏ 7.1 Precautions for safe handling No special precautions are necessary if used correctly.ꞏ Information about fire - and explosion protection: No special measures required.

ꞏ 7.2 Conditions for safe storage, including any incompatibilitiesꞏ Storage:ꞏ Requirements to be met by storerooms and receptacles: No special requirements.ꞏ Information about storage in one common storage facility: Not required.ꞏ Further information about storage conditions: None.ꞏ 7.3 Specific end use(s) No further relevant information available.

* SECTION 8: Exposure controls/personal protection

ꞏ Additional information about design of technical facilities: No further data; see item 7.

ꞏ 8.1 Control parametersꞏ Ingredients with limit values that require monitoring at the workplace:

26628-22-8 sodium azideIOELV Short-term value: 0.3 mg/m³

Long-term value: 0.1 mg/m³Skin

ꞏ Additional information: The lists valid during the making were used as basis.(Contd. on page 3)

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ꞏ 8.2 Exposure controlsꞏ Personal protective equipment:ꞏ General protective and hygienic measures: Wash hands before breaks and at the end of work.ꞏ Respiratory protection: Not required.ꞏ Protection of hands:

The glove material has to be impermeable and resistant to the product/ the substance/ the preparation.Due to missing tests no recommendation to the glove material can be given for the product/ the preparation/the chemical mixture.Selection of the glove material on consideration of the penetration times, rates of diffusion and thedegradationꞏ Material of gloves

The selection of the suitable gloves does not only depend on the material, but also on further marks of qualityand varies from manufacturer to manufacturer. As the product is a preparation of several substances, theresistance of the glove material can not be calculated in advance and has therefore to be checked prior to theapplication.ꞏ Penetration time of glove material

The exact break through time has to be found out by the manufacturer of the protective gloves and has to beobserved.ꞏ Eye protection: Not required.

* SECTION 9: Physical and chemical properties

ꞏ 9.1 Information on basic physical and chemical propertiesꞏ General Informationꞏ Appearance:

Form: FluidColour: According to product specification

ꞏ Odour: Characteristicꞏ Odour threshold: Not determined.

ꞏ pH-value: Not applicable.

ꞏ Change in conditionMelting point/freezing point: Undetermined.Initial boiling point and boiling range: Undetermined.

ꞏ Flash point: Not applicable.

ꞏ Flammability (solid, gas): Not determined.Not applicable.

ꞏ Decomposition temperature: Not determined.

ꞏ Auto-ignition temperature: Product is not selfigniting.

ꞏ Explosive properties: Product does not present an explosion hazard.

ꞏ Explosion limits:Lower: Not determined.Upper: Not determined.

ꞏ Vapour pressure: Not applicable.

ꞏ Density: Not determined.ꞏ Relative density Not determined.ꞏ Vapour density Not applicable.ꞏ Evaporation rate Not applicable.

ꞏ Solubility in / Miscibility withwater: Not miscible or difficult to mix.

ꞏ Partition coefficient: n-octanol/water: Not determined.(Contd. on page 4)

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ꞏ Viscosity:Dynamic: Not applicable.Kinematic: Not applicable.

ꞏ 9.2 Other information No further relevant information available.

SECTION 10: Stability and reactivity

ꞏ 10.1 Reactivity No further relevant information available.ꞏ 10.2 Chemical stabilityꞏ Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.ꞏ 10.3 Possibility of hazardous reactions No dangerous reactions known.ꞏ 10.4 Conditions to avoid No further relevant information available.ꞏ 10.5 Incompatible materials: No further relevant information available.ꞏ 10.6 Hazardous decomposition products: No dangerous decomposition products known.

* SECTION 11: Toxicological information

ꞏ 11.1 Information on toxicological effectsꞏ Acute toxicity Based on available data, the classification criteria are not met.ꞏ LD/LC50 values relevant for classification:

26628-22-8 sodium azideOral LD50 27 mg/kg (rat)Dermal LD50 20 mg/kg (rabbit)ꞏ Primary irritant effect:ꞏ Skin corrosion/irritation Based on available data, the classification criteria are not met.ꞏ Serious eye damage/irritation Based on available data, the classification criteria are not met.ꞏ Respiratory or skin sensitisation Based on available data, the classification criteria are not met.ꞏ CMR effects (carcinogenity, mutagenicity and toxicity for reproduction)ꞏ Germ cell mutagenicity Based on available data, the classification criteria are not met.ꞏ Carcinogenicity Based on available data, the classification criteria are not met.ꞏ Reproductive toxicity Based on available data, the classification criteria are not met.ꞏ STOT-single exposure Based on available data, the classification criteria are not met.ꞏ STOT-repeated exposure Based on available data, the classification criteria are not met.ꞏ Aspiration hazard Based on available data, the classification criteria are not met.

SECTION 12: Ecological information

ꞏ 12.1 Toxicityꞏ Aquatic toxicity: No further relevant information available.ꞏ 12.2 Persistence and degradability No further relevant information available.ꞏ 12.3 Bioaccumulative potential No further relevant information available.ꞏ 12.4 Mobility in soil No further relevant information available.ꞏ Ecotoxical effects:ꞏ Remark: Harmful to fishꞏ Additional ecological information:ꞏ General notes:

Water hazard class 1 (German Regulation) (Self-assessment): slightly hazardous for waterHarmful to aquatic organismsꞏ 12.5 Results of PBT and vPvB assessmentꞏ PBT: Not applicable.ꞏ vPvB: Not applicable.

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ꞏ 12.6 Other adverse effects No further relevant information available.

SECTION 13: Disposal considerations

ꞏ 13.1 Waste treatment methodsꞏ Recommendation

Must not be disposed together with household garbage. Do not allow product to reach sewage system.

ꞏ Uncleaned packaging:ꞏ Recommendation: Disposal must be made according to official regulations.

SECTION 14: Transport information

ꞏ 14.1 UN-Numberꞏ ADR, ADN, IMDG, IATA Void

ꞏ 14.2 UN proper shipping nameꞏ ADR, ADN, IMDG, IATA Void

ꞏ 14.3 Transport hazard class(es)

ꞏ ADR, ADN, IMDG, IATAꞏ Class Void

ꞏ 14.4 Packing groupꞏ ADR, IMDG, IATA Void

ꞏ 14.5 Environmental hazards:ꞏ Marine pollutant: Not applicable

ꞏ 14.6 Special precautions for user Not applicable.

ꞏ 14.7 Transport in bulk according to Annex II ofMarpol and the IBC Code Not applicable.

ꞏ UN "Model Regulation": Void

* SECTION 15: Regulatory information

ꞏ 15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture

ꞏ Directive 2012/18/EUꞏ Named dangerous substances - ANNEX I None of the ingredients is listed.ꞏ 15.2 Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

SECTION 16: Other informationThis information is based on our present knowledge. However, this shall not constitute a guarantee for anyspecific product features and shall not establish a legally valid contractual relationship.

ꞏ Relevant phrasesH300 Fatal if swallowed.H310 Fatal in contact with skin.H400 Very toxic to aquatic life.H410 Very toxic to aquatic life with long lasting effects.

ꞏ Department issuing SDS: Product safety department.ꞏ Contact: [email protected]ꞏ Abbreviations and acronyms:

ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the InternationalCarriage of Dangerous Goods by Road)


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IMDG: International Maritime Code for Dangerous GoodsIATA: International Air Transport AssociationGHS: Globally Harmonised System of Classification and Labelling of ChemicalsEINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)LC50: Lethal concentration, 50 percentLD50: Lethal dose, 50 percentPBT: Persistent, Bioaccumulative and ToxicvPvB: very Persistent and very BioaccumulativeAcute Tox. 2: Acute toxicity – Category 2Acute Tox. 1: Acute toxicity – Category 1Aquatic Acute 1: Hazardous to the aquatic environment - acute aquatic hazard – Category 1Aquatic Chronic 1: Hazardous to the aquatic environment - long-term aquatic hazard – Category 1Aquatic Chronic 3: Hazardous to the aquatic environment - long-term aquatic hazard – Category 3ꞏ * Data compared to the previous version altered.

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ꞏ Trade name: Anti-hCGβ-Sm tracer

ꞏ Article number: 13802696ꞏ 1.2 Relevant identified uses of the substance or mixture and uses advised against









The product is not classified, according to the CLP regulation.


ꞏ Labelling according to Regulation (EC) No 1272/2008 and 98/79The product is labelled according to the IVD regulationꞏ Hazard pictograms Voidꞏ Signal word Voidꞏ Hazard statements Voidꞏ 2.3 Other hazardsꞏ Results of PBT and vPvB assessmentꞏ PBT: Not applicable.ꞏ vPvB: Not applicable.


ꞏ 3.2 Chemical characterisation: Mixturesꞏ Description: Mixture of substances listed below with nonhazardous additions.

ꞏ Dangerous components: Voidꞏ Additional information: For the wording of the listed hazard phrases refer to section 16.

SECTION 4: First aid measures

ꞏ 4.1 Description of first aid measuresꞏ General information: No special measures required.ꞏ After inhalation: Supply fresh air; consult doctor in case of complaints.ꞏ After skin contact: Generally the product does not irritate the skin.ꞏ After eye contact: Rinse opened eye for several minutes under running water.ꞏ After swallowing: If symptoms persist consult doctor.ꞏ 4.2 Most important symptoms and effects, both acute and delayed No further relevant information available.


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ꞏ 4.3 Indication of any immediate medical attention and special treatment neededNo further relevant information available.

* SECTION 5: Firefighting measures


SECTION 6: Accidental release measures

ꞏ 6.1 Personal precautions, protective equipment and emergency procedures Not required.ꞏ 6.2 Environmental precautions: Dilute with plenty of water.ꞏ 6.3 Methods and material for containment and cleaning up:

Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).ꞏ 6.4 Reference to other sections

No dangerous substances are released.See Section 7 for information on safe handling.See Section 8 for information on personal protection equipment.See Section 13 for disposal information.

SECTION 7: Handling and storage

ꞏ 7.1 Precautions for safe handling No special measures required.ꞏ Information about fire - and explosion protection: No special measures required.


SECTION 8: Exposure controls/personal protection



The product does not contain any relevant quantities of materials with critical values that have to bemonitored at the workplace.ꞏ Additional information: The lists valid during the making were used as basis.

ꞏ 8.2 Exposure controlsꞏ Personal protective equipment:ꞏ General protective and hygienic measures:

The usual precautionary measures are to be adhered to when handling chemicals.ꞏ Respiratory protection: Not required.ꞏ Protection of hands:

The glove material has to be impermeable and resistant to the product/ the substance/ the preparation.Due to missing tests no recommendation to the glove material can be given for the product/ the preparation/the chemical mixture.Selection of the glove material on consideration of the penetration times, rates of diffusion and thedegradation


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ꞏ Material of glovesThe selection of the suitable gloves does not only depend on the material, but also on further marks of qualityand varies from manufacturer to manufacturer. As the product is a preparation of several substances, theresistance of the glove material can not be calculated in advance and has therefore to be checked prior to theapplication.ꞏ Penetration time of glove material

The exact break through time has to be found out by the manufacturer of the protective gloves and has to beobserved.ꞏ Eye protection: Goggles recommended during refilling

SECTION 9: Physical and chemical properties




ꞏ pH-value: Not determined.

ꞏ Change in conditionMelting point/freezing point: Undetermined.Initial boiling point and boiling range: 100 °C


ꞏ Flammability (solid, gas): Not applicable.





ꞏ Vapour pressure at 20 °C: 23 hPa

ꞏ Density: Not determined.ꞏ Relative density Not determined.ꞏ Vapour density Not determined.ꞏ Evaporation rate Not determined.

ꞏ Solubility in / Miscibility withwater: Fully miscible.

ꞏ Partition coefficient: n-octanol/water: Not determined.

ꞏ Viscosity:Dynamic: Not determined.Kinematic: Not determined.

ꞏ Solvent content:Water: 97.8 %

Solids content: 0.9 %ꞏ 9.2 Other information No further relevant information available.

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* SECTION 12: Ecological information

ꞏ 12.1 Toxicityꞏ Aquatic toxicity: No further relevant information available.ꞏ 12.2 Persistence and degradability No further relevant information available.ꞏ 12.3 Bioaccumulative potential No further relevant information available.ꞏ 12.4 Mobility in soil No further relevant information available.ꞏ Additional ecological information:ꞏ General notes: Not hazardous for water.ꞏ 12.5 Results of PBT and vPvB assessmentꞏ PBT: Not applicable.ꞏ vPvB: Not applicable.ꞏ 12.6 Other adverse effects No further relevant information available.


ꞏ 13.1 Waste treatment methodsꞏ Recommendation Smaller quantities can be disposed of with household waste.

ꞏ Uncleaned packaging:ꞏ Recommendation: Disposal must be made according to official regulations.


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ꞏ Recommended cleansing agents: Water, if necessary together with cleansing agents.
















ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the InternationalCarriage of Dangerous Goods by Road)IMDG: International Maritime Code for Dangerous GoodsIATA: International Air Transport AssociationGHS: Globally Harmonised System of Classification and Labelling of ChemicalsEINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)LC50: Lethal concentration, 50 percentLD50: Lethal dose, 50 percentPBT: Persistent, Bioaccumulative and ToxicvPvB: very Persistent and very Bioaccumulativeꞏ * Data compared to the previous version altered.

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ꞏ Trade name: DELFIA-2 Buffer

ꞏ Article number: 13802700, 13802699ꞏ 1.2 Relevant identified uses of the substance or mixture and uses advised against













ꞏ 3.2 Chemical characterisation: Mixturesꞏ Description: Mixture of substances listed below with nonhazardous additions.

ꞏ Dangerous components: Voidꞏ Additional information: For the wording of the listed hazard phrases refer to section 16.

SECTION 4: First aid measures

ꞏ 4.1 Description of first aid measuresꞏ General information: No special measures required.ꞏ After inhalation: Supply fresh air; consult doctor in case of complaints.ꞏ After skin contact: Generally the product does not irritate the skin.ꞏ After eye contact: Rinse opened eye for several minutes under running water.ꞏ After swallowing: If symptoms persist consult doctor.ꞏ 4.2 Most important symptoms and effects, both acute and delayed No further relevant information available.


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ꞏ 4.3 Indication of any immediate medical attention and special treatment neededNo further relevant information available.



SECTION 6: Accidental release measures













The glove material has to be impermeable and resistant to the product/ the substance/ the preparation.Due to missing tests no recommendation to the glove material can be given for the product/ the preparation/the chemical mixture.Selection of the glove material on consideration of the penetration times, rates of diffusion and thedegradation


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ꞏ Material of glovesThe selection of the suitable gloves does not only depend on the material, but also on further marks of qualityand varies from manufacturer to manufacturer. As the product is a preparation of several substances, theresistance of the glove material can not be calculated in advance and has therefore to be checked prior to theapplication.ꞏ Penetration time of glove material




Form: FluidColour: Red



ꞏ Change in conditionMelting point/freezing point: Undetermined.Initial boiling point and boiling range: Undetermined.















ꞏ 10.1 Reactivity No further relevant information available.(Contd. on page 4)

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ꞏ 10.2 Chemical stabilityꞏ Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.ꞏ 10.3 Possibility of hazardous reactions No dangerous reactions known.ꞏ 10.4 Conditions to avoid No further relevant information available.ꞏ 10.5 Incompatible materials: No further relevant information available.ꞏ 10.6 Hazardous decomposition products: No dangerous decomposition products known.





ꞏ 12.1 Toxicityꞏ Aquatic toxicity: No further relevant information available.ꞏ 12.2 Persistence and degradability No further relevant information available.ꞏ 12.3 Bioaccumulative potential No further relevant information available.ꞏ 12.4 Mobility in soil No further relevant information available.ꞏ Additional ecological information:ꞏ General notes: Not hazardous for water.ꞏ 12.5 Results of PBT and vPvB assessmentꞏ PBT: Not applicable.ꞏ vPvB: Not applicable.ꞏ 12.6 Other adverse effects No further relevant information available.


ꞏ 13.1 Waste treatment methodsꞏ Recommendation Smaller quantities can be disposed of with household waste.

ꞏ Uncleaned packaging:ꞏ Recommendation: Disposal must be made according to official regulations.ꞏ Recommended cleansing agents: Water, if necessary together with cleansing agents.

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ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the InternationalCarriage of Dangerous Goods by Road)IMDG: International Maritime Code for Dangerous GoodsIATA: International Air Transport AssociationGHS: Globally Harmonised System of Classification and Labelling of ChemicalsEINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)LC50: Lethal concentration, 50 percentLD50: Lethal dose, 50 percentPBT: Persistent, Bioaccumulative and ToxicvPvB: very Persistent and very Bioaccumulativeꞏ * Data compared to the previous version altered.

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ꞏ Trade name: DELFIA/AutoDELFIA Wash Concentrate

ꞏ Article number: B117-100, B117-100J, 4010-0010, 1244-114, 3014-0010ꞏ 1.2 Relevant identified uses of the substance or mixture and uses advised against









GHS07

Skin Sens. 1 H317 May cause an allergic skin reaction.


ꞏ Labelling according to Regulation (EC) No 1272/2008 and 98/79The product is labelled according to the IVD regulationThe product is classified and labelled according to the CLP regulation.ꞏ Hazard pictograms

GHS07

ꞏ Signal word Warning

ꞏ Hazard-determining components of labelling:N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolidinyl-4)-N'-(hydroxymethyl)ureaꞏ Hazard statements

H317 May cause an allergic skin reaction.ꞏ Precautionary statements

P261 Avoid breathing dust/fume/gas/mist/vapours/spray.P280 Wear protective gloves.P362+P364 Take off contaminated clothing and wash it before reuse.P333+P313 If skin irritation or rash occurs: Get medical advice/attention.P321 Specific treatment (see on this label).P501 Dispose of contents/container in accordance with local/regional/national/international

regulations.(Contd. on page 2)

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ꞏ 2.3 Other hazardsꞏ Results of PBT and vPvB assessmentꞏ PBT: Not applicable.ꞏ vPvB: Not applicable.

* SECTION 3: Composition/information on ingredients


CAS: 78491-02-8EINECS: 278-928-2

N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolidinyl-4)-N'-(hydroxymethyl)urea

Skin Sens. 1, H317

1-2.5%

ꞏ Additional information: For the wording of the listed hazard phrases refer to section 16.


ꞏ 4.1 Description of first aid measuresꞏ General information: Immediately remove any clothing soiled by the product.ꞏ After inhalation:

Supply fresh air and to be sure call for a doctor.In case of unconsciousness place patient stably in side position for transportation.ꞏ After skin contact: Immediately wash with water and soap and rinse thoroughly.ꞏ After eye contact: Rinse opened eye for several minutes under running water.ꞏ After swallowing: If symptoms persist consult doctor.ꞏ 4.2 Most important symptoms and effects, both acute and delayed No further relevant information available.ꞏ 4.3 Indication of any immediate medical attention and special treatment needed






Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).Dispose contaminated material as waste according to item 13.Ensure adequate ventilation.ꞏ 6.4 Reference to other sections


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* SECTION 7: Handling and storage

ꞏ 7.1 Precautions for safe handlingEnsure good ventilation/exhaustion at the workplace.Prevent formation of aerosols.ꞏ Information about fire - and explosion protection: No special measures required.


* SECTION 8: Exposure controls/personal protection





Immediately remove all soiled and contaminated clothingWash hands before breaks and at the end of work.ꞏ Respiratory protection:

In case of brief exposure or low pollution use respiratory filter device. In case of intensive or longer exposureuse self-contained respiratory protective device.ꞏ Protection of hands:

Protective gloves




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ꞏ Change in conditionMelting point/freezing point: Undetermined.Initial boiling point and boiling range: 100 °C
















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ꞏ 11.1 Information on toxicological effectsꞏ Acute toxicity Based on available data, the classification criteria are not met.ꞏ Primary irritant effect:ꞏ Skin corrosion/irritation Based on available data, the classification criteria are not met.ꞏ Serious eye damage/irritation Based on available data, the classification criteria are not met.ꞏ Respiratory or skin sensitisation

May cause an allergic skin reaction.ꞏ CMR effects (carcinogenity, mutagenicity and toxicity for reproduction)ꞏ Germ cell mutagenicity Based on available data, the classification criteria are not met.ꞏ Carcinogenicity Based on available data, the classification criteria are not met.ꞏ Reproductive toxicity Based on available data, the classification criteria are not met.ꞏ STOT-single exposure Based on available data, the classification criteria are not met.ꞏ STOT-repeated exposure Based on available data, the classification criteria are not met.ꞏ Aspiration hazard Based on available data, the classification criteria are not met.


ꞏ 12.1 Toxicityꞏ Aquatic toxicity: No further relevant information available.ꞏ 12.2 Persistence and degradability No further relevant information available.ꞏ 12.3 Bioaccumulative potential No further relevant information available.ꞏ 12.4 Mobility in soil No further relevant information available.ꞏ Additional ecological information:ꞏ General notes: Water hazard class 1 (German Regulation) (Self-assessment): slightly hazardous for waterꞏ 12.5 Results of PBT and vPvB assessmentꞏ PBT: Not applicable.ꞏ vPvB: Not applicable.ꞏ 12.6 Other adverse effects No further relevant information available.

* SECTION 13: Disposal considerations

ꞏ 13.1 Waste treatment methodsꞏ Recommendation

Must not be disposed together with household garbage. Do not allow product to reach sewage system.

ꞏ Uncleaned packaging:ꞏ Recommendation: Disposal must be made according to official regulations.ꞏ Recommended cleansing agents: Water, if necessary together with cleansing agents.








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ꞏ Directive 2012/18/EUꞏ Named dangerous substances - ANNEX I None of the ingredients is listed.ꞏ REGULATION (EC) No 1907/2006 ANNEX XVII Conditions of restriction: 3ꞏ 15.2 Chemical safety assessment: A Chemical Safety Assessment has not been carried out.


ꞏ Relevant phrasesH317 May cause an allergic skin reaction.


RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning theInternational Transport of Dangerous Goods by Rail)ICAO: International Civil Aviation OrganisationADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the InternationalCarriage of Dangerous Goods by Road)IMDG: International Maritime Code for Dangerous GoodsIATA: International Air Transport AssociationGHS: Globally Harmonised System of Classification and Labelling of ChemicalsEINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)PBT: Persistent, Bioaccumulative and ToxicvPvB: very Persistent and very BioaccumulativeSkin Sens. 1: Skin sensitisation – Category 1ꞏ * Data compared to the previous version altered.

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ꞏ Trade name: DELFIA /AutoDELFIA Enhancement Solution

ꞏ Article number: B118-100, 1244-105, 4001-0010, B118-100J, 1244-104ꞏ 1.2 Relevant identified uses of the substance or mixture and uses advised against


Laboratory chemicalsIn vitro diagnostics










* SECTION 3: Composition/information on ingredients


9002-93-1 Polyethylene glycol octylphenol ether Eye Dam. 1, H318; Aquatic Acute 1, H400; Aquatic Chronic 1, H410; Acute

Tox. 4, H302; Skin Irrit. 2, H315

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Trade name: DELFIA /AutoDELFIA Enhancement Solution

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ꞏ 4.1 Description of first aid measuresꞏ General information: No special measures required.ꞏ After inhalation: Supply fresh air; consult doctor in case of complaints.ꞏ After skin contact: Generally the product does not irritate the skin.ꞏ After eye contact: Rinse opened eye for several minutes under running water.ꞏ After swallowing: If symptoms persist consult doctor.ꞏ 4.2 Most important symptoms and effects, both acute and delayed No further relevant information available.ꞏ 4.3 Indication of any immediate medical attention and special treatment needed





ꞏ 6.1 Personal precautions, protective equipment and emergency procedures Not required.ꞏ 6.2 Environmental precautions: Do not allow to enter sewers/ surface or ground water.ꞏ 6.3 Methods and material for containment and cleaning up:











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Form: FluidColour: Colourless

ꞏ Odour: Odourlessꞏ Odour threshold: Not determined.

ꞏ pH-value at 20 °C: 3.2

ꞏ Change in conditionMelting point/freezing point: 0 °CInitial boiling point and boiling range: 100 °C









ꞏ Solubility in / Miscibility withwater: Soluble.

ꞏ Partition coefficient: n-octanol/water: Not determined.(Contd. on page 4)

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ꞏ Viscosity:Dynamic at 20 °C: 0.952 mPasKinematic: Not determined.

ꞏ Solvent content:Organic solvents: 0.7 %Water: 99.1 %

Solids content: 0.0 %ꞏ 9.2 Other information No further relevant information available.

* SECTION 10: Stability and reactivity



ꞏ 11.1 Information on toxicological effectsꞏ Acute toxicity Based on available data, the classification criteria are not met.ꞏ Primary irritant effect:ꞏ Skin corrosion/irritation Based on available data, the classification criteria are not met.ꞏ Serious eye damage/irritation Based on available data, the classification criteria are not met.ꞏ Respiratory or skin sensitisation Based on available data, the classification criteria are not met.ꞏ CMR effects (carcinogenity, mutagenicity and toxicity for reproduction)ꞏ Germ cell mutagenicity Based on available data, the classification criteria are not met.ꞏ Carcinogenicity Based on available data, the classification criteria are not met.ꞏ Reproductive toxicity Based on available data, the classification criteria are not met.ꞏ STOT-single exposure Based on available data, the classification criteria are not met.ꞏ STOT-repeated exposure Based on available data, the classification criteria are not met.ꞏ Aspiration hazard Based on available data, the classification criteria are not met.


ꞏ 12.1 Toxicityꞏ Aquatic toxicity: No further relevant information available.ꞏ 12.2 Persistence and degradability No further relevant information available.ꞏ 12.3 Bioaccumulative potential No further relevant information available.ꞏ 12.4 Mobility in soil No further relevant information available.ꞏ Additional ecological information:ꞏ General notes:

Do not allow product to reach ground water, water course or sewage system, even in small quantities.ꞏ 12.5 Results of PBT and vPvB assessmentꞏ PBT: Not applicable.ꞏ vPvB: Not applicable.ꞏ 12.6 Other adverse effects No further relevant information available.

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* SECTION 13: Disposal considerations

ꞏ 13.1 Waste treatment methodsꞏ Recommendation Hand over to hazardous waste disposers.

ꞏ Uncleaned packaging:ꞏ Recommendation:

Packagings that may not be cleansed are to be disposed of in the same manner as the product.













ꞏ Directive 2012/18/EUꞏ Named dangerous substances - ANNEX I None of the ingredients is listed.ꞏ LIST OF SUBSTANCES SUBJECT TO AUTHORISATION (ANNEX XIV)

9002-93-1 Polyethylene glycol octylphenol ether Sunset date: 2021-01-04

ꞏ National regulations:

ꞏ Other regulations, limitations and prohibitive regulationsꞏ Substances of very high concern (SVHC) according to REACH, Article 57

9002-93-1 Polyethylene glycol octylphenol etherꞏ 15.2 Chemical safety assessment: A Chemical Safety Assessment has not been carried out.


ꞏ Relevant phrasesH302 Harmful if swallowed.H315 Causes skin irritation.H318 Causes serious eye damage.


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H400 Very toxic to aquatic life.H410 Very toxic to aquatic life with long lasting effects.


RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning theInternational Transport of Dangerous Goods by Rail)ICAO: International Civil Aviation OrganisationADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the InternationalCarriage of Dangerous Goods by Road)IMDG: International Maritime Code for Dangerous GoodsIATA: International Air Transport AssociationGHS: Globally Harmonised System of Classification and Labelling of ChemicalsEINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)PBT: Persistent, Bioaccumulative and ToxicSVHC: Substances of Very High ConcernvPvB: very Persistent and very BioaccumulativeAcute Tox. 4: Acute toxicity – Category 4Skin Irrit. 2: Skin corrosion/irritation – Category 2Eye Dam. 1: Serious eye damage/eye irritation – Category 1Aquatic Acute 1: Hazardous to the aquatic environment - acute aquatic hazard – Category 1Aquatic Chronic 1: Hazardous to the aquatic environment - long-term aquatic hazard – Category 1ꞏ * Data compared to the previous version altered.

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Documents

20.11.2018 Kit components Product code Description A097 ......Printing date 20.11.2018 Revision: 03.11.2016 Trade name: hCG beta standards A-F (Contd. of page 5) 48.0.4 IMDG: International