Registration Dossier
Registration Dossier
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EC number: 606-239-2 | CAS number: 19130-96-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well reported GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (2R,3R,4R,5S)-2-(hydroxymethyl)piperidine-3,4,5-triol
- EC Number:
- 606-239-2
- Cas Number:
- 19130-96-2
- Molecular formula:
- C6 H13 N O4
- IUPAC Name:
- (2R,3R,4R,5S)-2-(hydroxymethyl)piperidine-3,4,5-triol
- Details on test material:
- Desoxynojirimycin, solid white to beige powder, content 97.2%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: paraffin oil
- Controls:
- not required
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
Results of the study:
| Irritant Effects (Scores) | ||||||||||
| 24 h | 48 h | 72 h | Mean scores | |||||||
| animal | erythema | edema | erythema | edema | erythema | edema | erythema | edema | ||
| 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Applicant's summary and conclusion
- Executive summary:
500 mg of the test substance was semi-occlusively applied to the shaved intact skin of 3 female rabbits for an exposure period of 4 h. Evaluation of skin irritation was made according to Draize.
In this skin irritation study Desoxynojirimycin was not irritating to the skin.
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