Registration Dossier
Registration Dossier
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EC number: 203-310-6 | CAS number: 105-57-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 949
Materials and methods
- Principles of method if other than guideline:
- Eye injury in rabbits is recorded in a 10-grade ordinal series and is based upon the degree of corneal necrosis that results from instillation of various volumes and concentrations of chemical.
- GLP compliance:
- no
Test material
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- other: undiluted sample or solutions in water or propylene glycol
- Amount / concentration applied:
- several amounts starting at 500μL (based on Carpenter et al., 1946, Chemical Burns of the Rabbit Cornea. Am.J.Opthal. 29:1363)
- Duration of treatment / exposure:
- no data
- Observation period (in vivo):
- no data
- Number of animals or in vitro replicates:
- no data (usually 5)
- Details on study design:
- SCORING SYSTEM: Grade 1 indicates at most a very small area of necrosis resulting from 0.5 ml of undiluted chemical in the eye. Grade 5 indicates a so-called severe burn f rom 0.005 ml, and Grade 10 indicates a severe burn from 0.5 ml of a 1% solution in water or propyene glycol.
Results and discussion
In vivo
Results
- Remarks on result:
- other: The primary eye irritation was graded as 2.
- Irritant / corrosive response data:
- The primary eye irritation was graded as 2. This corresponds to 0.5 ml of undiluted test substance resulting in a score between 1 and 5.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on the Harmonised classificatation Annesx VI of Regulation (EC) No 1272/2008 (CLP Regulation) the substance is classified as irritating to eyes cat. 2 (H319).
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