Registration Dossier
Registration Dossier
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EC number: 291-454-0 | CAS number: 90411-76-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: similiar to OECD guideline (instillation of only 50 mg , not 100 mg), no GLP
Data source
Reference
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ETAD-Subkomitee für Toxikologie: Empfohlenen Methoden zur toxikologischen Untersuchung von Farbstoffen und Hilfsmitteln
- Principles of method if other than guideline:
- Method: application of test substance into the conjunctival sac of one eye of each of 2 rabbits, .Observation period was 7 days.
- GLP compliance:
- no
Test material
- Reference substance name:
- Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts
- EC Number:
- 291-454-0
- EC Name:
- Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts
- Cas Number:
- 90411-76-0
- Molecular formula:
- Mixture of components, no definitve molecular formula existing.
- IUPAC Name:
- Complex mixture of phenazine dyes - IUPAC name not available
- Test material form:
- other: solid
- Details on test material:
- IUCLID4 Test substance::
commercial formulation, purity ca. 99%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- body weight at the start of the study: 3-4 kg
one male and one female rabbit
housing individually
diet ad libitum
water ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the opposite eye served as contol
- Amount / concentration applied:
- 50 mg/animal
- Duration of treatment / exposure:
- no data
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- Method: application of test substance into the conjunctival sac of one eye of each of 2 rabbits, .Observation period was 7 days., the opposite eye served as control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal:
- Time point:
- other: up to 7 days
- Score:
- ca. 0
- Max. score:
- 110
- Remarks on result:
- other: no irritation was observed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritant / corrosive response data:
- no reactions were observed
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
Application of 50 mg and not 100 mg test substance into the conjunctival sac of one eye of each of 2 rabbits; the untreated other eye served as control Observation period was 7 days. No reaction of the eyes were observed. Therefore, Nigrosin WLF has to be evaluated as non-irritating to the mucous membranes.
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