Registration Dossier
Registration Dossier
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EC number: 402-860-6 | CAS number: 110553-27-0 CG 25-1320; IRGANOX 1520; TK 12229/1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Body responsible for the test
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Body responsible for the test
- IUPAC Name:
- Body responsible for the test
Constituent 1
Test animals
- Species:
- other: no data
- Strain:
- not specified
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: 0.5 mL of substance was directly applied to an area of 6 cm^2 of shaved skin
- Controls:
- not specified
- Duration of treatment / exposure:
- 4h
- Observation period:
- 7 days
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 1
- Reversibility:
- fully reversible within: 7days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 0
- Reversibility:
- fully reversible within: 7 days
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- The value of the scores for erythema was 0 in one animal and 1 in two animals; however, the value of the scores for edema was 0 in all animals. The skin reaction observed were reversible until the end of the observation period on day 7. The substance is not classified as irritating to the skin.
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