Registration Dossier
Registration Dossier
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EC number: 500-287-7 | CAS number: 103170-26-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers, reaction products with 2-butanone oxime
- EC Number:
- 500-287-7
- EC Name:
- 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers, reaction products with 2-butanone oxime
- Cas Number:
- 103170-26-9
- Molecular formula:
- >= C48H81N9O9 (IPDI-Isocyanurate n=3, 2-butanone oxime-blocked)
- IUPAC Name:
- 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers, reaction products with 2-butanone oxime
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- SPF Quality
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks old; weights between 1.0 and 3.5 kg
- sex: males
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: solid was moistened with 0.3 mL water
- Controls:
- other: surrounding untreated skin area of test animals served as control
- Amount / concentration applied:
- Amount: 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours after application
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: non irritating tape
REMOVAL OF TEST SUBSTANCE
- 4 hours after application the dressing was removed and the skin cleaned of residual test substance using water
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Other effects:
- There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
Classification: not irritating- Executive summary:
In a study performed according to OECD 404 the test item was shown to be not irritating to rabbit's skin. No systemic intolerance reactions were observed.
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