Registration Dossier
Registration Dossier
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EC number: 431-230-3 | CAS number: 202483-62-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Start: 14 September 1999 Completed: 17 September 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Study performed according OECD and or EC guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Identification: TS-2863
Description: White solid
Batch: 85-36
Purity: 99.8%
Test substance storage: at room temperature in the dark
Stability under storage conditions: stable
Expiry date: 18 December 1998
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- other: acetone
- Amount / concentration applied:
- 500mg
- Duration of treatment / exposure:
- 4 hours
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No skin irritation was caused by 4 hours of exposure to TS-2863.
There was no evidence of a corrosive effect on the skin. - Other effects:
- No staining of the treated skin by the test substance was observed.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Three rabbits were exposed to 0.5 gram of TS-2863, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure.
No skin irritation was caused by 4 hours of exposure to TS-2863.
Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), TS-2863 does not have to be classified and has no obligatory labelling requirement for skin irritation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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