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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:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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:
- reduced appetite and activity (one to three days in survivors)
- increasing weakness
- collapse
- death

No further data available
Body weight:
No 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.