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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:
December 1977 to Juny 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study very similar to the OECD guideline 401 with no observed deviations and well documented. GLP status unknown. Study considered as comparable to a guideline study with acceptable restrictions, Klimisch 2.c study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): benzotrichlorid
- Physical state: liquid colorless with irritating fumes
No further data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: obtained from Winkelmann, Borchen/Kreis Paderborn
- Weight at study initiation: 160-220g
- Fasting period before study: 16 hours prior the exposure
- Housing: hold in makrolon cages, type III
- Diet (e.g. ad libitum): Altromin R ad libitum
- Water (e.g. ad libitum): water ad libitum

No further data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water and Cremophor EL
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw


DOSAGE PREPARATION (if unusual): formulated in water and Cremophor EL

No further data
Doses:
50, 500, 1500, 2000, 2500, 3500 mg/kg bw
No. of animals per sex per dose:
Fifteen
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations of clinical signs and mortality but no weighing
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, gross pathology of deceased animals.
No further data
Statistics:
Probit analysis

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
2 188 mg/kg bw
95% CL:
1 993 - 2 411
Sex:
female
Dose descriptor:
LD50
Effect level:
1 590 mg/kg bw
95% CL:
1 390 - 1 779
Mortality:
cf detailled results
Clinical signs:
Reduced activity, scrubby fur, labored breathing, and polyuria with sanguineous urine were observed as toxicological symptoms. Symptoms started within 15 minutes after treatment and persisted for 7 to 9 days.
Body weight:
No data
Gross pathology:
The gross pathology of deceased animals revealed empty intestinal tracts and white stipples on the stomach mucosa.
Other findings:
No data

Any other information on results incl. tables

Detailled results of acute oral toxicity of benzotrichloride for male rats:

Dose (mg/kg bw) Time point of first deaths Toxicological results, number of rats:
dead with intoxication signs tested
50 - 0 0 15
500 - 0 15 15
1500 24h 1 15 15
2000 24h-4d 3 15 15
2500 24h-2d 12 15 15
3500 7h-24h 15 15 15

Detailled results of acute oral toxicity of benzotrichlorid for female rats:

Dose (mg/kg bw) Time point of first deaths Toxicological results, number of rats:
dead with intoxication signs tested
50 - 0 0 15
500 - 0 15 15
1000 3d 1 15 15
1500 24h-2d 5 15 15
2000 24h-2d 13 15 15
2500 24h-2d 14 15 15
3500 7h-24h 15 15 15

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information if swallowed Criteria used for interpretation of results: EU
Conclusions:
In an equivalent OECD 401 acute oral toxicity test, the authors found a LD 50 of 2188 mg/kg bw for male Wistar rats and a LD 50 of 1590 mg/kg bw for female rats. At this level of information, benzotrichloride should therefore be considered as acute oral toxicant category 4 according to the CLP regulation n° 1272/2008 EC.
Executive summary:

The acute oral toxicity of benzotrichloride (CAS n° 98 -07 -7) was investigated using male and female Wistar rats (n=15 per sex and dose group) in a test very similar to the OECD guideline 401. The authors treated the rats by gavage with the test substance formulated in water containing Cremophor EL. Mortality and clinical signs were investigated during fourteen days after the exposure. All deceased animals were checked for gross pathology symptoms of intoxication. LD 50 were estimated by probit analysis.

LD50 values of 2,188 and 1,590 mg/kg bw were found for male and female rats, respectively. During the observation period of fourteen days, reduced activity, scrubby fur, labored breathing, and polyuria with sanguineous urine were observed as toxicological symptoms. Symptoms started within 15 minutes after treatment and persisted for 7 to 9 days. The gross pathology of deceased animals revealed empty intestinal tracts and white stipples on the stomach mucosa.

At this level of information, benzotrichloride should therefore be considered as an acute oral toxicant category 4 according to the CLP regulation n° 1272/2008 EC.

The GLP status of this experiment is unknwon but the requirement of the OECD guideline 401 were fulfilled. The study is sufficiently described and should therefore be considered as reliable with restrictions, a Klimisch 2.c study, comparable to a guideline study with acceptable restrictions.