Registration Dossier
Registration Dossier
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EC number: 203-464-4 | CAS number: 107-12-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- not specified
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 0.5 mL undiluted substance was applied to the skin of New Zealand Albino rabbits. Area of skin was abraded or intact prior to administration of substance.
Four out of 6 animals died within 24 hours and therefore a reduced amount (0.2 mL) was employed for the study.
The substance was kept in contact with skin for 24 hours - covering type not specified. - GLP compliance:
- not specified
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.2 ml undiluted
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 168 hours
- Number of animals:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 0.61
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 0.39
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 1.1
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not a dermal irritant in an vivo skin irritation study conducted in rabbits.
- Executive summary:
The irritant or corrosive effects of the substance when applied dermally was evaluated in six New Zealand White rabbits. Six rabbits were dosed dermally with the substance (0.5mL/animal) to one intact and abraded site/rabbit. At this concentration four out of 6 animals died within 24 hours and therefore the study was repeated using 0.2 mL of the substance. The substance was kept in contact with skin for 24 hours - covering type not specified. Dermal reactions were scored at 24, 48, 72 and 168 hours following patch removal. Erythma and oedema was barely perceptible at 48 hours following patch removal and absent at 72 hours. It is concluded that the substance is not a dermal irritant.
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