Registration Dossier
Registration Dossier
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EC number: 204-287-5 | CAS number: 118-92-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1960
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Deviations from guideline, but sufficient information available to identify subststance as an eye irritant. Little information on test item.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 960
- Report date:
- 1960
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Observation period 10 days. 2 instead of 3 animals. Slightly different scoring system.
- GLP compliance:
- no
Test material
- Reference substance name:
- Anthranilic acid
- EC Number:
- 204-287-5
- EC Name:
- Anthranilic acid
- Cas Number:
- 118-92-3
- Molecular formula:
- C7H7NO2
- IUPAC Name:
- 2-aminobenzoic acid
- Details on test material:
- Name of the test substance used in the study report: Anthranilsaeure trocken = o-Aminobenzoesaeure
substance type: solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.73 kg (animal 1) and 3.09 kg (animal 2)
ENVIRONMENTAL CONDITIONS
no data
IN-LIFE DATES: From: 1960-02-16 To: 1960-02-26
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye of the animal was treated with talcum powder.
- Amount / concentration applied:
- ca. 50 mm3
- Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 10 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- After instillation, the test substance was not washed out.
Non standard scoring system (similar to Draize):
conjunctivae redness: grade 0, 1, 2, 3 (very slight redness, slight redness, redness)
chemosis: 0, 1, 2, 3/4 (slight chemosis, chemosis, strong chemosis)
cornea grade: 0, 1, 2, 3, 4 (slight opacity, moderate opacity, opacity, corrosion)
iris grade: 0, 1, 2slight iritis, iritis
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- other: 24, 48 and 72h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24.48 and 72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Chemosis was observed during the first 3h after treamtent.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 10 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24.48 and 72h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72h
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- fully reversible
Any other information on results incl. tables
| Time | Observations (Animal 1) | Observations (Animal 2) | |
| day 0 | 10 min | slight redness and chemosis, slight opacity. Discharge | slight rednessand very slight chemosis, slight opacity. Discharge |
| 60 min | slight redness, chemosis, bleeding of the conjunctivae, opacity | slight redness and chemosis, slight opacity. | |
| 180 min | redness, chemosis, opacity | redness and chemosis, opacity. | |
| day 1 | redness, slight iritis, opacity, hairloss in the vicinity of the eye | redness, iritis, opacity. | |
| day 2 | redness, slight iritis, opacity, hairloss in the vicinity of the eye | redness, opacity. | |
| day 3 | redness, slight iritis, opacity, hairloss in the vicinity of the eye | redness, opacity. | |
| day 6 | redness, scar formation at upper eyelid, opacity | slight redness, slight opacity | |
| day8 | redness, scar formation at upper eyelid, slight opacity | slight redness, slight opacity | |
| day10 | redness, scar formation at upper eyelid, slight opacity | slight opacity | |
| Body weight (Animal 1) | Body weight (Animal 2) | ||
| day 0 | 2.73 kg | 3.09 kg | |
| day 6 | 2.66 kg | 3.12 kg | |
| day10 | 2.54 kg | 3.1 kg |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The substance is classified as H318 according to Regulation (EC) no. 1272/2008, as R41 Directive 67/548/EEC respectively.
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