Registration Dossier
Registration Dossier
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EC number: 252-478-7 | CAS number: 35274-05-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1958
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed in pre-GLP period but sufficient detail reported.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 958
- Report date:
- 1958
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The irritation index is based on the Draize method in this study. Presently, this method is no longer used for determination of the degree of irritation.
- GLP compliance:
- no
Test material
- Reference substance name:
- Hexadecyl lactate
- EC Number:
- 252-478-7
- EC Name:
- Hexadecyl lactate
- Cas Number:
- 35274-05-6
- Molecular formula:
- C19H38O3
- IUPAC Name:
- hexadecyl lactate
- Details on test material:
- 25% in mineral oil
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- open
- Preparation of test site:
- abraded
- Vehicle:
- other: mineral oil
- Controls:
- not required
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 3
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 30 days
- Score:
- >= 0
- Reversibility:
- no data
- Other effects:
- no other effect
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No irritation.
- Executive summary:
The results show that all the animal treated showed a normal weight gain, sacrificed area showed normal healing, blood count showed no deviation from normal and the histological examination of the skin taken from the experimental area showed a normal picture.
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