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EC number: 700-854-0 | CAS number: 256473-04-8
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline and GLP compliant study with good documentation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-chloro-3-(2,2,2-trifluoroethoxy)pyridine
- EC Number:
- 700-854-0
- Cas Number:
- 256473-04-8
- Molecular formula:
- C7H5ClF3NO
- IUPAC Name:
- 2-chloro-3-(2,2,2-trifluoroethoxy)pyridine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Hanlbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd.; biotechnology & Animal Breeding Division; 4414 Füllingsdorf; Switzerland
- Age at study initiation: approx. 8 to 12 weeks
- Weight at study initiation: 204 - 243 g
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days prior to treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50% +/- 20%
- Air changes (per hr): 13-14/hour
- Photoperiod (hrs dark / hrs light): 12/12 hours
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80
- Details on dermal exposure:
- TEST SITE
- Area of exposure: about 6x4 cm
- % coverage: approx. 8% of body surface
- Type of wrap if used: Gauze patches (6x4 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water
- Time after start of exposure :after 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 400 mg application suspension/100 g body weight (200 mg a.i./100 g bw)
- Concentration (if solution): Diluted 50:50 with the vehicle
- Constant volume or concentration used: yes
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): 200 mg/100 g bw
- Concentration (if solution): 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80 - Duration of exposure:
- 24 h
- Doses:
- 2000 mg / kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before application and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- none
Results and discussion
- Preliminary study:
- not reported
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 1 828 mg/kg bw
- Based on:
- act. ingr.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 1 828 mg/kg bw
- Based on:
- act. ingr.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: There were no remarkable clinical observations for any animal.
- Gross pathology:
- Necropsy examinations revealed no observable abnormalities.
- Other findings:
- There were no remarkable findings for local tolerance for any animal.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
The acute dermal toxicity of CTFEP (purity 91.4%) to rat was determined in a GLP compliant test according to OECD 423 (Sommer 2000). Since the study was performed under GLP and according the guideline and based on the good documentation the study was awarded with Klimisch 1. The acute dermal toxicity testing in 5 male and 5 female rats showed that the LD50 of the test item (containing 91.4 % CTFEP) was > 2000mg/kg body weight. No mortality was observed. There were no remarkable clinical observations for any animal. There were no effects on body weight development in males. A slight loss of body weight was recorded in one female during the first week after treatment and in one female during the second week after treatment. Necropsy examinations revealed no observable abnormalities. There were no remarkable findings for local tolerance for any animal.
The obtained results are considered as relevant for the risk assessment.
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