Registration Dossier
Registration Dossier
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EC number: 201-837-6 | CAS number: 88-51-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: publication not sufficient for full methodological assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Guideline:
- other: detailed description of methodology not published
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-amino-6-chlorotoluene-3-sulphonic acid
- EC Number:
- 201-837-6
- EC Name:
- 4-amino-6-chlorotoluene-3-sulphonic acid
- Cas Number:
- 88-51-7
- Molecular formula:
- C7H8ClNO3S
- IUPAC Name:
- 2-amino-4-chloro-5-methylbenzene-1-sulfonic acid
- Test material form:
- other: test sample undiluted
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 85 mg solid per animal
- Duration of treatment / exposure:
- no 1: 20 sec after administration of the test substance right eye of one animal rinsed with water for 1 min.
no. 2: no subsequent rinsing with water of the right eye of the second animal
left eyes untreated - Observation period (in vivo):
- 1 and 4 hrs, 1, 2, 3, 7 days
- Number of animals or in vitro replicates:
- 2 (male)
Results and discussion
Any other information on results incl. tables
Results of the rinsed right eye:
Conjunctiva: mild swelling and mild discharge only at the day of treatment; no other conjunctival effect
Cornea: no effect
Iris: no effect
Results of the unrinsed right eye:
Conjunctiva: mild redness, mild swelling, copious discharge during the 1st day after treatment
Cornea: slight opacity during the first 3 days after treatment, disappeared by 7 days after treatment
Iris: moderate congestion during the 1st day after treatment
Applicant's summary and conclusion
- Interpretation of results:
- other: irritating effects
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- The mean for the rating of irritating effects to cornea (slight opacity) at 24h, 48h, 72 h is 1. Since only one animal is tested the substance is classified preventatively as irritating to eyes, cat. 2 according to (EC) No 1272/2008.
There is no classifictation according to Directive 67/548/EEC.
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