Registration Dossier
Registration Dossier
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EC number: 203-764-5 | CAS number: 110-40-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Guideline:
- other: National decree 5 April 1971 on official methods of analysis for cosmetics and beauty products
- Principles of method if other than guideline:
- official method for the evaluation of the irritant potential by direct application of rabbit corneal fibroblasts on monolayers by the neutral red release method
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Diethyl sebacate
- EC Number:
- 203-764-5
- EC Name:
- Diethyl sebacate
- Cas Number:
- 110-40-7
- Molecular formula:
- C14H26O4
- IUPAC Name:
- diethyl sebacate
Constituent 1
Test system
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- 10% - 25% - 50% - 100%
- Duration of treatment / exposure:
- 60 secondes
- Duration of post- treatment incubation (in vitro):
- Not specified
- Number of animals or in vitro replicates:
- Not specified
Results and discussion
In vitro
Results
- Irritation parameter:
- other: percentage of mortality
- Value:
- 0
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, the aim was the evaluation of the occular irritant potential of "Diethyl sebacate batch 021006" by direct application to rabbit corneal fibrobast monolayers by the neutral red release method. Under the experimental conditions, sample "DIETHYL SEBACATE Batch 1727003" is considered not to be cytotoxic.
- Executive summary:
For that endpoint, one reliable study on the registered substance was performed.
In this study, the aim was the evaluation of the occular irritant potential of "Diethyl sebacate batch 021006" by direct application to rabbit corneal fibrobast monolayers by the neutral red release method. Under the experimental conditions, sample "Diethyl sebacate batch 021006" is considered not to be cytotoxic.
The validity criteria were successful and the study was therefore regarded as acceptable for that endpoint.
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