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EC number: 217-442-7 | CAS number: 1852-16-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
The skin sensitisation potential of the read-across material, acrylamide, was assessed according to OECD Test Guideline 406 using a guinea pig maximisation test. The read-across material is considered sensitising.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- See the Analogue Approach Report attached in Section 13 of the IUCLID dossier.
- Reason / purpose for cross-reference:
- other: Read across to target substance
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Existing non-LLNA data avaliable
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: -9 weeks
- Weight at study initiation: males = mean 353.9 ± 33.5; female= mean 343.4 ± 16.3
- Housing: 2 or 3 animals in Makrolon ll-cages of appropriate size
- Diet (e.g. ad libitum): Food "3022" from Altromin International Lage, Germany batch n° 1115 and 0808
- Water: Ad libitum: Drinking water for the animals consisted of normal tap water from municipal sources Städtische Werke Krefeld AG
- Acclimation period:At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature : 20°C (17 - 23 °C)
- Humidity : 30-70 %
- Air changes (per hr): 8 times/hour
- Photoperiod (hrs dark / hrs light): 12-hour - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Route:
- other:
- Vehicle:
- other:
- Concentration / amount:
- Intradermal: 0.1 mL of 3.5 % (v/v) solution
Dermal: soaked patch with undiluted test substance (50 % (vlv))
Challenge: Duhring chamber with soaked patch of 25 % (vlv) solution - Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal:0.1 mL of 3.5 % (v/v) solution
Dermal: soaked patch with undiluted test substance (50 % (v/v))
Challenge: Duhring chamber with soaked patch of 25 % (v/v) solution - No. of animals per dose:
- 20 test and 10 control
- Details on study design:
- RANGE FINDING TESTS:
Intradermal: 0.1 mL of 0.5, 2.0, 3.5 and 5.0 % (v/v) solution
Dermal: soaked patch with undiluted test substance (50 % (v/v)), 35, 20 and 5.0 % (v/v) solution
Challenge: Duhring chamber with soaked patch of undiluted test substance and 25 % (v/v) solution
MAIN STUDY
Intradermal: 0.1 mL of 3.5 % (v/v) solution
Dermal: soaked patch with undiluted test substance (50 % (v/v))
Challenge: Duhring chamber with soaked patch of 25 % (v/v) solution
Adjuvant: Freund's Adjuvant complete (FCA), Behringwerke AG, Marburg, Germany, No. OREC 20/21, Batch No. 377010 A.
Due to strong skin reactions and heavy crust formation with this batch in former experiments FCA was diluted 1 + 2 with sesame oiL.
VALIDATION:
Reference substance: Neomycintrisulfate trihydrate, Fluka Chemie AG, Buchs, Switzerland, No. 72133, Batch No. 299279 1090
Concentrations:
Intradermal: 0.1 mL of 2.0 % (w/v) solution
Dermal: soaked patch with 20 % (w/v) solution
Challenge: Duhring chamber with soaked patch of 2.0 % (w/v) solution - Challenge controls:
- Duhring chamber with soaked patch of 25 % (v/v) aquaous solution
- Positive control substance(s):
- not required
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % (v/v) solution
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- discrete to intense erythema and edema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % (v/v) solution. No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: discrete to intense erythema and edema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % (v/v) solution
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- discrete to intense erythema and edema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % (v/v) solution. No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: discrete to intense erythema and edema.
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- On the basis of these results, acrylamide should be considered as a skin sensitiser in animals.
Reference
Systemic toxic symptoms after application were not observed at any time during the study. Body weight development was positive and within normal ranges. No erythema and edema were observed at any time point after the challenge application in the control group. There were apparently no skin reactions in control animals but 85% of test animals gave a positive response.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The skin sensitisation potential of the read-across material, acrylamide, was assessed according to OECD Test Guideline 406 using a guinea pig maximisation test. The sensitisation potential was assessed using intradermal application of 0.1 mL of a 3.5 % (v/v) solution, the dermal application of a soaked patch with undiluted test substance (50 % v/v) and challenge with a soaked patch of 25 % (v/v). At a dose level of 25 % (v/v) solution of the read-across substance 17 of the 20 animals had a positive reaction with discrete to intense erythema and oedema. Systemic toxic symptoms after application were not observed at any time during the study. Body weight development was positive and within normal ranges. The read-across material, acrylamide, is therefore considered sensitising.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The read-across material, acrylamide, elicited a sensitisation reaction in 17 out of 20 guinea pigs tested and is therefore considered as a Category 1 skin sensitiser.
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