Registration Dossier
Registration Dossier
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EC number: 288-422-3 | CAS number: 85721-12-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo
- Type of information:
- other: experimental study on similar substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: different data report by Colipa
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Different guidelines followed
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- EC Number:
- 247-368-0
- EC Name:
- Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- Cas Number:
- 25956-17-6
- Molecular formula:
- C18H16N2O8S2.2Na
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- other: intact and scarified
- Vehicle:
- other: unchanged and water or hydropylic cream preparation
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 1° Test: dye was applied at doses of 0.316, 1, 4, 3.16 and 10 g/kg
2° Test: dye was applied in a solution of 0.1, and 1% in water or hydrphylic cream preparation - Duration of treatment / exposure:
- 1° Test: no data
2° Test: repeated application for intact skin: 5 times a week for 13 weeks; for scarified skin: 5 times a week for 3 weeks - Number of animals:
- 1° Test: 4 animals for group
2° Test: 7 animals for group (intact skin); 2 animals for group (scarified skin)
Results and discussion
In vivo
Results
- Irritation parameter:
- other: irritant effect
- Basis:
- mean
- Time point:
- other: after 13 weeks
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The tested substance is not irritant for skin.
- Executive summary:
In the first test, no irritant effects were seen on rabbit skin.
In the second test, slight to moderate irritation was noted but clinical invenstigation did not reveal any substance related effects.
Based on the test results, the tested substance is not to be considered as irritant for skin.
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