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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999
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:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
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

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. 7 to 11 weeks
- Weight at study initiation: 169 - 217 g
- Fasting period before study: over-night prior to dosing
- Housing: three same-sex animals per cage
- 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):
- Photoperiod (hrs dark / hrs light): 12/12 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2000 mg/10 mL
- Amount of vehicle (if gavage): 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: pre-test results
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing: observations: 1, 2, 3, 4, 5, 6 hours after dosing, daily from day 1 to day 14, weighing days 0, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs, body weight, necropsy
Statistics:
none

Results and discussion

Preliminary study:
not provided
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
1 male was found dead after 1 day, no further mortality occurred during the test.
Clinical signs:
Slight piloerection and hunched posture were seen in both surviving males (nos. 1 and 2) on days 2 and 3 after treatment and in two females (nos 31 and 33) on Day 6 through Day 10 after treatment. One female (no 32) showed slight up to moderate piloerection and hunched posture on Day 5 through Day 10 after treatment. Both surviving males (nos. 1 and 2) appeared normal by Day 4 after treatment, and all females after Day 11 after treatment.
Body weight:
A severe loss of body weight was recorded in one female (no. 32) during the first week after treatment.
Gross pathology:
Necropsy examinations revealed no observable abnormalities.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 2000 mg/kg
Executive summary:

The acute oral toxicity of CTFEP (purity 99%) to rat was determined in a GLP compliant test according to OECD 423 (Sommer 1999). 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 toxicity testing in 3 male and 3 female rats showed that the LD50 of the test item was > 2000mg/kg body weight. One day after treatment one male was found dead. No further mortalities were observed. The body weight evolution was not influenced during the 14-day observation period, except for one female which showed a weight loss until day 7 but recovered until day 14. All surviving animals showed piloerection and hunched posture within few days after administration but all of them recovered until day 14. All treated animals were free from poisoning symptoms after 11 days at the latest.

The obtained results are considered as relevant for the risk assessment.