Registration Dossier
Registration Dossier
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EC number: 201-714-7 | CAS number: 86-98-6
Acute Toxicity: oral
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:
- 2 020
- 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
- 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
Constituent 1
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:
- other: 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.
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