Registration Dossier
Registration Dossier
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EC number: 234-232-0 | CAS number: 10605-21-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Carbendazim
- EC Number:
- 234-232-0
- EC Name:
- Carbendazim
- Cas Number:
- 10605-21-7
- Molecular formula:
- C9H9N3O2
- IUPAC Name:
- carbendazim
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Weight range of 3.0 to 3.5 kg and app. 13 to 15 weeks of age prior to treatment (day 1).
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- App. 65 mg of carbendazim (occupying a volume of 0.1 ml) was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated.
- Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- At 1, 24, 48, 72 hours after instillation.
- Number of animals or in vitro replicates:
- 4 males
- Details on study design:
- In a screening study, one eye of one animal was exposed for 30 sec. before being rinsed with distilled water. In the main study, a further animal was treated in advance of the other two without being rinsed (to sort out a compound with severe irritating potential).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- There were no signs of toxicity or ill health in any rabbit. Some slight findings were noted in the screening animals and the animals of the main study which resolved within one or two days.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Instillation of Carbendazim into rabbit eye elicited transient very slight to well defined conjunctival irritation. The effects observed were not sufficient to require classification and labelling.
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