Registration Dossier
Registration Dossier
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EC number: 207-444-6 | CAS number: 471-53-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex 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:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Enoxolone
- EC Number:
- 207-444-6
- EC Name:
- Enoxolone
- Cas Number:
- 471-53-4
- Molecular formula:
- C30H46O4
- IUPAC Name:
- 3-hydroxy-11-oxoolean-12-en-30-oic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- other: Bovine corneas
- Remarks:
- Bovine corneas
- Details on test animals or tissues and environmental conditions:
- Bovine corneas were used. They were collected from slaughtered cattle which were be-tween 12 and 60 months old.
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Replicate 1:447.1 mg
Replicate 2:443.3 mg
Replicate 3: 448.6 mg - Duration of treatment / exposure:
- Exposure time on the corneas was 4 hours at 32 ± 1 °C.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 0.18
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test item Enoxolone showed no effects on the cor-nea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 0.18.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.
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