Registration Dossier
Registration Dossier
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EC number: 616-586-1 | CAS number: 78068-85-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- 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:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Origin of test animals: Harlan Winkelmann GmbH, Gartenstraße 27, D33178 Borchen
Body weight at the start of study:
Male animals 238-248 g, mean 243 g, S.D. +/- 5.0 g
Female animals 178-180 g, mean 179 g, S.D. +/- 1.2 g
Age at the start of study: 6-10 weeks
Acclimatization: at least five days
Food: ssniff® R/M-H (V 1534), ad libitum
Photoperiod: 12 hours light / dark cycle
Relative humidity: 50 ± 20 %
Water: tap water in plastic bottles, ad libitum
Animal maintenance: in transparent macrolon® cages (type IV) on soft wood granulate in an air-conditioned room, 3 animals per cage
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Sesame oil
- Details on oral exposure:
- Application volume: 10 mL/kg body weight
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- The observation period following treatment lasted for 14 days. Symptoms were recorded twice every day (in the morning and in the afternoon).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the whole study.
- Clinical signs:
- other: The following clinical signs were observed after the administration of 3-chloro-4-fluorobenzotrifluoride: Hypoactivity, irregular respiration, uncoordinated and stilted gait. Additional , drawn in flanks were noted in female animals. From day 4 until the
- Gross pathology:
- The animals killed at the end of the observation period showed no macroscopically visible changes.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study the median lethal dose value (LD50) of 3-chloro-4-fluorobenzotrifluoride is greater than 2000 mg/kg body weight.
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