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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-05-31 to 1990-09-14
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987-02-24
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
α,α,α-trifluoro-4-nitro-m-cresol
EC Number:
201-818-2
EC Name:
α,α,α-trifluoro-4-nitro-m-cresol
Cas Number:
88-30-2
Molecular formula:
C7H4F3NO3
IUPAC Name:
α,α,α-trifluoro-4-nitro-m-cresol
impurity 1
Chemical structure
Reference substance name:
5-chloro-α,α,α-trifluoro-2-nitrotoluene
EC Number:
204-280-7
EC Name:
5-chloro-α,α,α-trifluoro-2-nitrotoluene
Cas Number:
118-83-2
Molecular formula:
C7H3ClF3NO2
IUPAC Name:
4-Chloro-1-nitro-2-(trifluoromethyl)benzene
impurity 2
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
Dihydrogen oxide
impurity 3
Chemical structure
Reference substance name:
3-Carboxy-4-nitrophenol
Cas Number:
610-37-7
Molecular formula:
C7H5NO5
IUPAC Name:
3-Carboxy-4-nitrophenol
Test material form:
liquid
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

OTHER SPECIFICS: dark brown liquid

Test animals

Species:
rat
Strain:
other: Crl:CD BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Inc.
- Age at study initiation: young adult, ~ 8 weeks
- Weight at study initiation: 200 - 300 g
- Fasting period before study: over night
- Housing: seperated by sex and group for the definitive portion of the study, individually for the range-finding portion of the study; in screen-bottom stainless stell cages.
- Diet: ad libitum, Rodent Chow #5001, Purina Mills
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1990-06-11 To: 1990-07-16

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 6.42 mL/kg bw
DOSAGE PREPARATION: The test material was dosed undiluted, using the bulk density to determine the dose volume and corrected for active ingredient (A.I.) (calculated dose/A.I. = dose to be administered). Individual doses were calculated based upon the animal´s body weight.
The test material was mixed with deionized water at a specific concentration for each dose level. Each test mixture was mixed during dosing to maintain a uniform suspension. Adjustments in the administered dose volume were made to account for the 77.9 % purity of the test material. An individual dose was calculated for each animal based upon its fasted body weight and administered by gavage using a dose volume of 6.42 mL/kg.
Doses:
50, 100, and 200 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 1, 2.5, and 4 h after test substance administration and daily thereafter for at least 14 days for clinical signs and twice daily for mortality.
- Frequency of weighing: before study initiation, at day 7 and day 14 after test substance administration, and at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
The LD50 value for male, female and the sexes combined was determined by a computer program utilizing a modified Behrens-Reed-Muench Cumulant Method. No other statistical analyses were performed.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
160 mg/kg bw
Based on:
test mat.
95% CL:
> 95 - < 272
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
141 mg/kg bw
Based on:
test mat.
95% CL:
> 77 - < 259
Sex:
male/female
Dose descriptor:
LD50
Effect level:
151 mg/kg bw
Based on:
test mat.
95% CL:
> 102 - < 224
Mortality:
In the 50 mg/kg bw dose group, no mortality was observed. In the 100 mg/kg bw dose group, 1 out of 5 male and 2 out of 5 female animals died after test substance administration. In the 200 mg/kg bw dose group, 3 out of 5 male and 3 out of 5 female animals died after test substance administration.
Clinical signs:
All surviving animals appeard normal during the observation period of 14 days.
Body weight:
All surviving animals exhibited body weight gains throughout the study except for one female treated at 50 mg/kg bw which exhibited a 6 g weight loss between day 7 and day 14.
Gross pathology:
Yellowish-green semi-fluid material in the stomach of each animal and diffusely light yellow color of the mucosa. The cecum of males in the 50 mg/kg bw group had enlarged lumen. The observations were considered to be unrelated to the test material.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The LD50 of the test substance in rat was 141 mg/kg bw.
Executive summary:

In an acute oral toxicity study similar to OECD guideline 401, groups of 5/sex ~8 week old Charles River (Crl:CD°BR) rats were given a single oral dose of the test substance (50, 100, and 200 mg/kg bw) (Hazleton Laboratories, 1990). An observation period of 14 days followed administration. Weighing of the animals was performed before study initiation, at day 7, and at day 14 after test substance administration. Necropsy was performed on died and surviving animals.There were no treatment related clinical signs, necropsy findings or changes in body weight. An oral LD50 (based on ♀) of 141 mg/kg bw was determined.

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