Registration Dossier
Registration Dossier
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EC number: 701-385-4 | CAS number: -
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:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Body weights not reported
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction products of Benzeneamine, N-phenyl- with nonene (branched)
- EC Number:
- 701-385-4
- Cas Number:
- 36878-20-3
- Molecular formula:
- C21H29N - C30H47N (main constituents)
- IUPAC Name:
- Reaction products of Benzeneamine, N-phenyl- with nonene (branched)
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Test material name: Naugalube 438L CN 5294300
Supplier: Uniroyal Inc.
Description: Brown viscous liquid
storage at ambient temperature and humidity
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino, not further specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Nicholas Helf
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: 2 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): controlled
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: From: 1 August 1983 To: 4 August 1983
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 3 ays
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The test article was placed by syringe or syringe-type applicator into the conjunctival sac which was formed by gently pulling the lower eye1 i d away frorn the
eye. After instilllation, the lids were held together briefly to insure adequate distribution of the test article, One eye of each rabbit was dosed. The contralateral
eye served as a control. No washing step was included.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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:
- 2
- 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:
- 3
- 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:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- None of the six treated animals showed any sign of ocular irritation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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