Registration Dossier
Registration Dossier
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EC number: 616-586-1 | CAS number: 78068-85-6
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:
- 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:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-chloro-1-fluoro-4-(trifluoromethyl)benzene
- EC Number:
- 616-586-1
- Cas Number:
- 78068-85-6
- Molecular formula:
- C7H3ClF4
- IUPAC Name:
- 2-chloro-1-fluoro-4-(trifluoromethyl)benzene
- Reference substance name:
- 1-Chloro-2-fluoro-4-(trifluoromethyl)benzene
- Cas Number:
- 32137-20-5
- Molecular formula:
- C7H3ClF4
- IUPAC Name:
- 1-Chloro-2-fluoro-4-(trifluoromethyl)benzene
- Test material form:
- liquid
Constituent 1
impurity 1
- Specific details on test material used for the study:
- Purity: 89.5 % [a/a]
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Origin of animals: Charles River Deutschland GmbH, 88353 Kißlegg
Body weight at start of study: 3.6-3.8 kg
Individual housing
Humidity: 50+/- 20 %
Room temperatur:20+/-3 °C
Photoperiod: 12/12 h light/dark
Feeding: ssniff® K-H (V2333), ad libitum and hay (approx. 15 g/d)
Acclimatization: 1 week under study conditions
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 mL test substance per plaster
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- The animals were shaved with an electronic clipper 24 hours before the experiment was accomplished.Only animals with an intact skin were used.
The substance was applied over the whole surface of a 2.5 x2.5 cm cellulose patch on apiece of surgical plaster (specially produced by Beiersdorf AG, Hamburg). The plaster was fixed with a semi-occlusive bandage.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- No signs of irritation were observed during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study 3-chloro-4-fluorobenzotrifluoride is not irritating to skin.
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