Registration Dossier
Registration Dossier
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EC number: 812-526-5 | CAS number: 53831-80-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- See attached justification for supporting informaiton.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Undiluted o-toluidine was applied to the intact and to the scarified skin of the flank of rabbits under occlusive conditions. Following the 24-hour treatment time the treated area was washed with water.
Study conducted in 1979 - no guideline available. - GLP compliance:
- not specified
- Remarks:
- Study conducted in 1979. Endpoint from collected of data and compliance details are not available.
Test material
- Reference substance name:
- o-toluidine
- EC Number:
- 202-429-0
- EC Name:
- o-toluidine
- Cas Number:
- 95-53-4
- Molecular formula:
- C7H9N
- IUPAC Name:
- o-toluidine
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Remarks:
- both intact skin and abraded skin had o-toluidine applied
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Applied Undiluted, No volume stated.
- Duration of treatment / exposure:
- 24 hour treatment
- Observation period:
- 72 hour observation
- Number of animals:
- 6 animals (intact skin) and in 6 animals (scarified skin)
- Details on study design:
- undiluted o-toluidine was applied to the intact and to the scarified skin of the flank of rabbits under occlusive conditions. Following the 24-hour treatment time the treated area was washed with water.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Time point:
- other: up to 8 days
- Reversibility:
- not specified
- Remarks on result:
- other: moderately irritating
- Irritant / corrosive response data:
- Slight to moderate erythema and moderate edema of the intact skin were observed for 72 hours. At 72 hours
these animals exhibited scaling, which was still observed on day 8. Necrosis was observed in 1/6
animals (intact skin) and in 6/6 animals (scarified skin) until termination of the study. Overall, the
authors evaluated o-toluidine as moderately irritating.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- O-toluidine was assed as being moderately irritating. It is therefore not classified for skin irritation.
- Executive summary:
Slight to moderate erythema and moderate edema of the intact skin were observed for 72 hours. At 72 hours
these animals exhibited scaling, which was still observed on day 8. Necrosis was observed in 1/6
animals (intact skin) and in 6/6 animals (scarified skin) until termination of the study. Overall, the
authors evaluated o-toluidine as moderately irritating.
Not classified for skin irritation.
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