Registration Dossier
Registration Dossier
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EC number: 201-063-9 | CAS number: 77-85-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable and sufficiently documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Principles of method if other than guideline:
- 2 animals, application inside rabbit ear, exposure period 24 h, dose 500 mg/animal, post exposure period 7 days.
- GLP compliance:
- no
Test material
- Reference substance name:
- Propylidynetrimethanol
- EC Number:
- 201-074-9
- EC Name:
- Propylidynetrimethanol
- Cas Number:
- 77-99-6
- Molecular formula:
- C6H14O3
- IUPAC Name:
- 2-ethyl-2-(hydroxymethyl)propane-1,3-diol
- Details on test material:
- No further data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- white New Zealand rabbits, weight 3 to 4 kg
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- other: the oposite ear served as control
- Amount / concentration applied:
- amount: 500 mg
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 2
- Details on study design:
- 2 rabbits, application of 500 mg/animal moistened with water, at the inside of one ear of each of the 2 rabbits ( the other ear served as control), and fixed with a plaster for the exposure period of 24 h, then the skin was washed with water and soap, postexposure period 7 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 0 h, 2 and 7 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 0 h, 2 and 7 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritant / corrosive response data:
- According to the available data the substance is not irritating
- Other effects:
- no data
Any other information on results incl. tables
According to the available data the substance is not irritating
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
Application of 500 mg Trimethylolpropane/rabbit on the inner surface of one rabbit's ear of each of the 2 rabbits (the other one served as control) for 24 hours followed by a 7-day-observation period, does not result in irritational effects at any time point (Bayer AG 1979).
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