α-chlorotoluene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The authors tested the acute oral toxicity with a methodology similar to the OECD Guideline 401 (Acute Oral Toxicity) on Sprague-Dawley rats. Although GLP standards were not specified, sufficient data was given concerning materials and methodology. Hence the study should be considered a Klimisch 2e as it is well documented, meets generally accepted scientific principles and is acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

number of animals per sex

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

α-chlorotoluene

EC Number:

202-853-6

EC Name:

α-chlorotoluene

Cas Number:

100-44-7

Molecular formula:

C7H7Cl

IUPAC Name:

(chloromethyl)benzene

Constituent 2

Reference substance name:

chloromethylbenzene

IUPAC Name:

chloromethylbenzene

Details on test material:

- Name of test material (as cited in study report): benzyl chloride

No more data available

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: average initial weight ranged from 210 to 220 g (see table 1 in remarks on results including tables and figures)

No more data available

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 631 mg/kg

No more data available

Doses:

316, 398, 501 and 631 mg/kg

No. of animals per sex per dose:

Males:
For the dosages 316 and 501 mg/kg each time 3 males were exposed
For the dosages 398 and 631 mg/kg each time 2 males were exposed

Females:
For the dosages 316 and 501 mg/kg each time 2 females were exposed
For the dosages 398 and 631 mg/kg each time 3 females were exposed

See also table 1 (given in remarks on results including tables and figures)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, gross pathology

No more data available

Statistics:

No data

Results and discussion

Preliminary study:

No data available

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

560 mg/kg bw

95% CL:

510 - 620

Mortality:

See table 1 (given in remarks on results including tables and figures)

No further data available

Clinical signs:

other: - reduced appetite and activity (one to three days in survivors) - increasing weakness - collapse - death No further data available

Gross pathology:

- lung and liver hyperemia
- gastrointestinal inflammation

No further data available

Other findings:

- Survivors (14 days): viscera appeared normal

No further data available

Any other information on results incl. tables

_ Table 1: Dosages, average initial weight, amount of rats dosed, mortality and time of mortality.

Dosage (mg/kg)	Average initial weight (g)		Mortalities/Dosed			Time of mortality
	Male	Female	Male	Female	Combined
316	215	210	0/3	0/2	0/5
398	210	210	1/2	0/3	1/5
501	210	210	0/3	1/2	1/5	One day
631	220	220	2/2	2/3	4/5

No further data available

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information if swallowed Criteria used for interpretation of results: EU

Conclusions:

The authors tested the acute oral toxicity of benzyl chloride with a methodology similar to the OECD Guideline 401 (Acute Oral Toxicity). An LD50 was reported of 560 mg/kg for Sprague-Dawley albino rats (i.e. males and females combined). Thus, at this level of information, benzyl chloride should be classified as harmfull if swallowed according to the CLP regulation (EC) No 1272/2008.

Executive summary:

The authors tested the acute oral toxicity of benzyl chloride (CAS n° 100-44-7) with a methodology similar to the OECD Guideline 401 (Acute Oral Toxicity). A total of five Sprague-Dawley albino rats (2 or 3 of each sex) were exposed to four dosages of undiluted test substance and mortality, signs of intoxication and gross pathalogy were checked.

Under these test conditions, an LD50 was found of 560 mg/kg (95% C.L.: 510 -620 mg/kg). Hence, the result indicates that benzyl chloride should be classified harmfull if swallowed according to the CLP regulation (EC) No 1272/2008.

GLP standards were not specified but sufficient data was given concerning materials and methods. The method for the calculation of the LD 50 is unknown and the number of animals per sex is not consistent for all concentrations. A greater number of animals would have been beneficial but basic checkings and results are reported. Hence the study should be considered reliable with restrictions, a Klimisch 2.e study.