Registration Dossier
Registration Dossier
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EC number: 600-198-4 | CAS number: 101377-47-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
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:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect at the time of study conduct.
- GLP compliance:
- yes
Test material
- Reference substance name:
- bis(4-fluorophenyl)methyl(4H-1,2,4-triazol-4yl-methyl)silane
- EC Number:
- 600-198-4
- Cas Number:
- 101377-47-3
- Molecular formula:
- C16H15N3F2Si
- IUPAC Name:
- bis(4-fluorophenyl)methyl(4H-1,2,4-triazol-4yl-methyl)silane
- Details on test material:
- - Purity: R7623 Technical, solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 55 minutes; 24, 48 and 72 hours after dressing removal
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: range
- Time point:
- other: 55 minutes to 72 hours
- Score:
- 0 - 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: 2 of 3 rabbits had very slight erythema at 55 minutes
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 55 minutes to 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no irritation observed
Applicant's summary and conclusion
- Interpretation of results:
- other: minimally irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test substance need not be labeled as a skin irritant
- Executive summary:
The flank skin of 3 albino rabbits was exposed to 0.5 g of the test substance moistened with 0.5 mL Milli-RO water for 4 hours using semi-occlusive dressings. The test substance caused no adverse effects to the skin, except very slight erythema in 2 animals 55 minutes after bandage removal.
The primary skin irritation index amounts to 0. Based on these results, the test substance should be considered minimally irritating to the skin.
According to the criteria laid down in Annex VI of the EED Council Directive 67/548/EEC (amended by Directive 83/467/EEC), the test substance need not be classified as a skin irritant.
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