Registration Dossier
Registration Dossier
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EC number: 208-952-0 | CAS number: 548-61-8
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: test procedure meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Principles of method if other than guideline:
- According to ETAD-Subkomitee für Toxikologie 'Empfohlene Methoden zur toxikologischen Untersuchung von Farbstoffen und Hilfsmitteln'.
The test substance was instilled in one eye of each of 3 rabbits. Observation period was 7 days. - GLP compliance:
- no
Test material
- Reference substance name:
- 4,4',4''-methylidynetrianiline
- EC Number:
- 208-952-0
- EC Name:
- 4,4',4''-methylidynetrianiline
- Cas Number:
- 548-61-8
- Molecular formula:
- C19H19N3
- IUPAC Name:
- 4,4',4''-methylidynetrianiline
Constituent 1
Test animals / tissue source
- Species:
- rabbit
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the second eye of each rabbit served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Observation period (in vivo):
- 1 h, 24 h, 48 h, 72 h and 7 days after treatment
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: 1 h after treatment score 1 for erythema
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 1 h after treatment score 1 for erythema and edema
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 1 h after treatment score 2 for erythema and score 1 for edema
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
Instillation of the test substance into one eye of each of three rabbits led to slight erythema in two animals. All effects were fully reversible within the observation time of 7 days. Thus, under the conditions of this test the test substance was slightly irritating to the eyes of rabbits. According to EU Regulation 1272/2008 no classification for eye irritation is warranted.
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