Registration Dossier
Registration Dossier
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EC number: 203-596-2 | CAS number: 108-58-7
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- A dose of 50 mg Chohedur RK (= m-phenylene di(acetate)) was administered into one eye of two young adult New Zealand white rabbits (3–4 kg). The eyes were examined and the grade of ocular reaction was recorded until day 7 post administration according to Draize.
- GLP compliance:
- no
Test material
- Reference substance name:
- m-phenylene di(acetate)
- EC Number:
- 203-596-2
- EC Name:
- m-phenylene di(acetate)
- Cas Number:
- 108-58-7
- Molecular formula:
- C10H10O4
- IUPAC Name:
- 3-(acetyloxy)phenyl acetate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 50 mg
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Duration of post- treatment incubation (in vitro):
- None
- Number of animals or in vitro replicates:
- 2 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.83
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- All effects were fully reversible within 7 days.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the Draize scores for cornea opacity and conjunctivae a classification as eye irritant is adequate.
- Executive summary:
A dose of 50 mg Chohedur RK (= m-phenylene di(acetate)) was administered into one eye of two young adult New Zealand white rabbits (3–4 kg). The eyes were examined and the grade of ocular reaction was recorded until day 7 post administration according to Draize. The cornea score was 2.66, the iris score was 0.83 and the conjunctivae and chemosis score were 2.33 and 1.33, respectively. All effects were reversible within 7 days. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification as Eye Irrit. 2 ( H319: Causes serious eye irritation.) is justified.
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