α,α,α-trichlorotoluene

Acute Toxicity: oral

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

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

α,α,α-trichlorotoluene

EC Number:

202-634-5

EC Name:

α,α,α-trichlorotoluene

Cas Number:

98-07-7

Molecular formula:

C7H5Cl3

IUPAC Name:

α,α,α-trichlorotoluene

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 or test system 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 levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

2 188 mg/kg bw

95% CL:

1 993 - 2 411

Effect levels 2

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.