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EC number: 434-600-2 | CAS number: 2628-16-2
- 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 substance was found to be a skin sensitizer in accordance with the criteria described in the Guinea Pig Maximisation Test.
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:
- 09.07.-09.08.1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea-pig is a good animal model for predicting delayed contact hypersensitivity in man.
- Specific details on test material used for the study:
- C-908 (Acetoxystyrene monomer - ASM), purity > 99%
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Test Animals:
- Body weight 217 - 302 g at arrival
- bred under hygenic conditions
Animal husbandry:
- no more than five guinea pigs per stainless steel cage, measuring 55 x 60 x 23 cm with grid floors and tops
- located in a limited access building
- approx. 15 aire changes per hour
- temperature: 18°C (range 15 - 23°C)
- humidity: 55% r.h. (range 40 - 70% r.h.)
- artificial light with a 12 h light / dark cycle
- diet: petteted guinea-pig diet ad libitum
- water: free access to tap water - Route:
- intradermal
- Vehicle:
- olive oil
- Concentration / amount:
- 3% v/v
- Day(s)/duration:
- on day 1
- Adequacy of induction:
- other: well toleated dose as tested in a screening test
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.6 mL test substance
- Day(s)/duration:
- on day 8 for 48 hours
- Adequacy of induction:
- other: well toleated dose as tested in a screening test
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- neat substance
- Day(s)/duration:
- on day 22 for 24 hours
- Adequacy of challenge:
- other: well toleated dose as tested in a screening test
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 30% v/v of the test substance
- Day(s)/duration:
- on day 22 for 24 hours
- Adequacy of challenge:
- other: well toleated dose as tested in a screening test
- No. of animals per dose:
- 10 animals per sex per dose
- Details on study design:
- Preparation of the animals:
- examnation on delivery and needed to be in a good state of health
- weight assessment: animals weighed at arrival
- identification: tattooed ear-marks
- acclimatisation: 10 days
- application site: 4 x 6 cmoverlying the scapulae wsa clipped free of hair before treatment
- body weight: 318 - 439 g at the before treatment
Preparation of test material:
- fresh doses were prepared before administration
- test material in olive oil, Freunds Complete Adjuvant or olive oil and Freunds Complete Adjuvant
A primary skin irritation test has been performed in order to determine the concentration limits for the main study
Control group for the main study:
- treated identically to the test group (induction and challenge) except that during induction the test material was replaced by vehicle
Primary induction:
- intradermal injection at day 1
- three pairs of injections (0.1 mL) (see table below)
- dermal test site 4 x 2 cm
- dermal responses assessed after 24 and 48 h after injection
Secondary induction:
- clipped dorsa treated with 10% w/v sodium lauryl sulphate in petrolatum on day 7
- occluded topical application of 0.6 mL (test item or olive oil) on a 4 x 2.5 cm absorbent patch on day 8 for 48 hours
- dermal responses assessed after 24 and 48 h after removal of occlussive dressing
Challenge procedure:
- clipped area of 5 x 5 cm on both flanks
- left side: topical application of 0.03 mL of olive oil on day 22
- right side: topical application of 0.03 mL of test item to one site and 0.03 mL 30% test item v/v in olive oil to a second site
- covered by occlusive dressing for 24 h
Assessment of the challenge reactions:
- examined approx. 24 and 48 h, after removal of the occlusive dressing
- presence or absence of erythema and swellings were assessed and the degree of reaction scored on a five point scale (see table below)
Body weight:
- recorded a weekly intevalls
Mortality and termination procedure:
- dead animals were subjected to necropsy
- all surviving animals were sacrificed at termination of the study - Challenge controls:
- treated identically to the test group (induction and challenge) except that during induction the test material was replaced by vehicle
- Positive control substance(s):
- no
- Positive control results:
- not applicable
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% test item
- No. with + reactions:
- 10
- Total no. in group:
- 19
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% test item
- No. with + reactions:
- 18
- Total no. in group:
- 19
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30% v/v test item in olive oil
- No. with + reactions:
- 3
- Total no. in group:
- 19
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30% v/v test item in olive oil
- No. with + reactions:
- 12
- Total no. in group:
- 19
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- other: Skin sensitizer according to criteria as determined in the GPMT.
- Conclusions:
- In conclusion, the response in pretreated animals clearly indicates that acetoxystyrene is a potent skin sensitizer in guinea pigs by the maximization procedure and caused delayed contact hypersensitivity.
- Executive summary:
The present skin sensitization study was performed in guinea-pigs by the maximization procedure. The test was performed according to OECD TG 406 and in compliance to GLP. Ten males and ten females were used for the control groups, the olive oil, the neat test item and the 30% v/v test item in olive oil group. The animals were intradermally induced at day one (primary induction) and dermally induced (second induction) at day 8 for 48 hours under occlusion. The animals were challenged topically on day 22 and examined after approx. 24 and 48 h.
The incidence of significant dermal responses (slight erythema or more marked reaction) to challenge with the neat test item or 30% v/v test item in olive oil was considerably greater in test group animals than in the control animals. Altough the olive oil caused a slight irritant effect per se the severity of the response in the test group animals was far more severe than that of the control animals and was considered to be consistent with an allergic reaction.
Forty-eight hours after challenge exposure to neat acetoxystyrene, the maximum number of responding animals was 18 out of the 19 test animals. This response classifies the test material as an extreme sensitizer using the classification scheme proposed by Magnusson and Kligman. A positive response to the challenge dose was also observed in 12 of 19 animals with a 30% preparation of the test material in olive oil.
In conclusion, the test material itself produced some skin irritation in control animals. However, the response in pretreated animals clearly indicates that acetoxystyrene is a potent skin sensitizer in guinea pigs by the maximization procedure and caused delayed contact hypersensitivity in guinea-pigs.
Reference
Bodyweight and general health
All surviving animals generaly made expected bodyweight gains during the study.
One test group animal was found dead on day 11. This was considered as incidental and not related to the test item.
Incidence of significant dermal response to challenge with olive oil, neat test item and 30% v/v test item in olive oil
Group | Treatment | No. of animals | Incidence of significant responses+ | Total responders | |
24 hours | 48 hours | ||||
Control | Olive oil | 20 | 1 | 5 | 6 |
Test | Olive oil | 19* | 2 | 4 | 4 |
Control | test item (as supplied) | 20 | 6 | 5 | 7 |
Test | test item (as supplied) | 19* | 10 | 18 | 18 |
Control | 30% v/v test item in olive oil | 20 | 0 | 2 | 2 |
Test | 30% v/v test item in olive oil | 19* | 3 | 12 | 13 |
+ slight erythema or a marked response (grade 1 or above)
* one male animal was found dead on day 11
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance was found to cause effects associated with skin sensitisation in a Guinea Pig Maximisation Test according to OECD and GLP criteria. As it concerns a non-LLNA test, the test outcome is not directly comparable to the CLP criteria. Hence, the substance is classified as as Skin Sensitiser Cat. 1 without distincting between 1A and 1B.
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