Registration Dossier
Registration Dossier
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EC number: 200-920-4 | CAS number: 75-97-8
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:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye 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:
- 3,3-dimethylbutanone
- EC Number:
- 200-920-4
- EC Name:
- 3,3-dimethylbutanone
- Cas Number:
- 75-97-8
- Molecular formula:
- C6H12O
- IUPAC Name:
- 3,3-dimethylbutanone
- Test material form:
- liquid
1
Test animals / tissue source
- Species:
- chicken
- Details on test animals or tissues and environmental conditions:
- enucleated chicken eye
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 µl of pure substance
- Duration of treatment / exposure:
- 10 seconds
- Duration of post- treatment incubation (in vitro):
- 240 min
- Details on study design:
- Treatment 10 sec
Rinse
Evaluation at 30, 75, 120, 180 and 240 minutes after the post-treatment rinse
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Maximal mean
- Value:
- 1.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- Mean
- Value:
- 2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Maximal mean
- Value:
- 10
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The eye irritation potential was determined according to OECD 438 guideline on chicken eyes. The study shows the following results :
- maximal mean score of corneal opacity = 1.7 --> corresponding to ICE class III
- mean score of fluorescein retention = 2 --> corresponding to ICE class III
- maximal mean corneal swelling = 10% --> corresponding to ICE class II
The results obtained lead to the category "no prediction can be made" as defined by OECD guideline; therefore, the substance is not predicting as causing serious eye damage or as not classified for eye irritation/serious eye damage (No category). - Executive summary:
The eye irritation potential was determined according to OECD 438 guideline on chicken eyes. The study shows the following results :
- maximal mean score of corneal opacity = 1.7 --> corresponding to ICE class III
- mean score of fluorescein retention = 2 --> corresponding to ICE class III
- maximal mean corneal swelling = 10% --> corresponding to ICE class II
The results obtained lead to the category "no prediction can be made" as defined by OECD guideline; therefore, the substance is not predicting as causing serious eye damage or as not classified for eye irritation/serious eye damage (No category).
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