Registration Dossier
Registration Dossier
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EC number: 473-450-2 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 April 2006 - 28 April 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Méthode B4 Toxicité aiguë (irritation de la peau) de la Directive 2004/75/CE de la Commission.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- No. 338 Red
- IUPAC Name:
- No. 338 Red
- Details on test material:
- Description: red powder
Batch number: 50670
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: moistened with distilled water
- Controls:
- not required
- Amount / concentration applied:
- Amount: 0.5 g of test material, moistened with 0.5 ml of distilled water
- Duration of treatment / exposure:
- First animal: three time points, 3 minutes, 1 hour and 4 hours
Two additional animals: 4 hours - Observation period:
- Approximately 1 hours following the removal of the patches and 24, 48 and 72 hours alter, the test sites were examined for evidence of primary irritation.
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: pink coloured staining, 4 hours exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: pink coloured staining, 4 hours exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 48 hours
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: pink coloured staining, 4 hours exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: pink coloured staining, 4 hours exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: pink coloured staining, 4 hours exposure; 24 hour observation not performed
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: pink coloured staining, 4 hours exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: pink coloured staining, 4 hours exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: pink coloured staining, 4 hours exposure; 24 hour observation not performed
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: pink coloured staining, 4 hours exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: pink coloured staining, 4 hours exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animals #1, #2, #3
- Time point:
- other: 1-72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 4 hours exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: 1 hour exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: 1 hour exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 1 hour exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 1 hour exposure
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1-72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 1 hour exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1-72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 3 minutes exposure
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1-72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 3 minutes exposure
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 3 days
- Other effects:
- Pink coloured staining was noted at all treated skin site after 4 hours exposure throughout the study. The staining did not affect evaluation of skin responses.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: other: CLP, Regulation No 1272/2008
- Conclusions:
- Based on a skin irritation study in rabbits, the test substance is not considered skin irritating. Although pink colouration was observed after 4 hours exposure to the test substance which persisted untill the end of the observation period, the substance needs no classification according to CLP.
- Executive summary:
Erythema score 1 was noted in 1 animal at 1, 24 and 48 hours after 4 hours exposure to the test substance. In the second animal, erythema score 1 was only noted at 1 hour after 4 hours exposure to the test substance. No erythema was noted in the third animal. Oedema formation was not observed in any of the animals after 4 hours exposure to the test substance.
All animals showed pink colouration of the test substance through the study period.
After 1 hour exposure to the test substance, the animal showed erythema score 1 at 1 and 24 hours. No oedema formation was observed.
After 3 minutes exposure to the test substance, no erythema nor oedema formation was noted.
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