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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data from secondary source

Data source

Reference
Reference Type:
other: Secondary Literature
Title:
HPVIS- Acute oral toxicity for the test chemical
Author:
HPVIS
Year:
2020
Bibliographic source:
HPVIS, 2020

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
An acute toxicity study of the test chemical was carried out in rats to determine its LD50.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-chlorotoluene
EC Number:
203-397-0
EC Name:
4-chlorotoluene
Cas Number:
106-43-4
Molecular formula:
C7H7Cl
IUPAC Name:
1-chloro-4-methylbenzene
Test material form:
solid
Details on test material:
Name of the test chemical: Benzene, 1-chloro-4-methyl-
Molecular Formula: C7H7Cl
Molecular Weight: 126.585 g/mol
Substance Type: Organic
Physical State: Solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Age: adult
Weight at study initiation: 205-240 gram averages/dose group

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
no data available
Doses:
2000, 2510, 3160, 3980 and 5010 mg/kg
No. of animals per sex per dose:
5 rats/ dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on day 1 and day 14
- Necropsy of survivors performed: yes/no:No data available
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:No data available
Statistics:
no data available

Results and discussion

Preliminary study:
No data available
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 350 mg/kg bw
Based on:
test mat.
95% CL:
> 2 090 - < 2 620
Mortality:
50% mortality was not observed at 2350 mg/kg
Clinical signs:
No data available
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The LD50 values were considered to be (with 95% confidence limits) 2350 (2060-2620) mg/kg in males and in females when Sprague Dawley rats were treated with the test chemical orally.
Executive summary:

An acute toxicity study of the test chemical was carried out in male and female Sprague Dawley rats to determine its LD50. 5 male and female rats were dosed with 2000, 2510, 3160, 3980 and 5010 mg/kg of the test chemical orally via gavage. The treated rats were observed for mortality and other effects till 14 days. The LD50 values were considered to be (with 95% confidence limits) 2350 (2060-2620) mg/kg in males and in females when Sprague Dawley rats were treated with the test chemical orally.