Registration Dossier
Registration Dossier
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EC number: 215-350-1 | CAS number: 1323-03-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: no GLP but the method used was based on scientifically accepted method.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- method used was a modified Draize method.
- GLP compliance:
- no
Test material
- Reference substance name:
- Tetradecyl lactate
- EC Number:
- 215-350-1
- EC Name:
- Tetradecyl lactate
- Cas Number:
- 1323-03-1
- Molecular formula:
- C17H34O3
- IUPAC Name:
- tetradecyl 2-hydroxypropanoate
- Test material form:
- not specified
- Details on test material:
- The test material used is synthetic ceraphyl 50 with a batch number of 5630
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zeland
- Details on test animals or tissues and environmental conditions:
- Animals were received from Summit view farm, Belvidere, New Jersey. The animals are fed and watered ad libitum; with wayne animal feeds used exclusively. Text material were applied on intact and abraded skin and was covered with an impermeable occlussive wrapping. The wrapping were removed 24h following application.
Test system
- Vehicle:
- not specified
- Controls:
- other: the left eye that was untreated served as a control
- Amount / concentration applied:
- 0.1ml per eye
- Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- other: Total score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 20
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- other: Total score
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 20
- Remarks on result:
- no indication of irritation
- 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:
- The test compound is not an ocular irritant.
- Executive summary:
The numerical scoring point according to Draize standard scoring was 0. Thus, the test compound is not an ocular irritant.
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