Registration Dossier
Registration Dossier
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EC number: 270-485-3 | CAS number: 68442-68-2
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: Scientifically reasonable study on the registered substance itself with some deficiencies in documentation. However, given data indicate that the study was well-performed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
- Principles of method if other than guideline:
- Test item was applied to the conjunctival sac of two rabbits, post-observation period was 7 days.
- GLP compliance:
- no
- Remarks:
- study performed prior to GLP implementation
Test material
- Reference substance name:
- Benzenamine, N-phenyl-, styrenated
- EC Number:
- 270-485-3
- EC Name:
- Benzenamine, N-phenyl-, styrenated
- Cas Number:
- 68442-68-2
- Molecular formula:
- not applicable (UVCB substance)
- IUPAC Name:
- 4-(1-phenylethyl)-N-[4-(1-phenylethyl)phenyl]aniline
- Test material form:
- liquid: viscous
- Details on test material:
- - Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: male/female
- Weight at study initiation: 3-4 kg
- Housing: individually
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100µl - Duration of treatment / exposure:
- 7 days (no wash-out after application denoted)
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: mean 1, 2, 3, 7 days
- Score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: not irritating
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The study was conducted with a scientifically reasonable study design on the registered substance itself with some deficiencies in documentation. However, the given data indicate that the study was well performed. Hence, the results can be considered as sufficiently reliable to assess the irritating potential of the test item towards rabbits. The results indicate that the substance is not irritating to the rabbit eye and no classification as eye irritant according to Regulation 1272/2008 is triggered.
- Executive summary:
In a primary eye irritation study, 100µl of the undiluted test item was instilled into the conjunctival sac of the eye of two New Zealand White rabbits (m/f). Animals then were observed for 7 days.
In this study, the test item is not an eye irritant and does not need to be classified.
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