Registration Dossier
Registration Dossier
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EC number: 215-535-7 | CAS number: 1330-20-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, near guideline study, published in peer reviewed literature, limitations in design and/or reporting but otherwise adequate for assessment.
- Justification for type of information:
- N/A
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 962
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Single dermal dose under occlusion followed by observation for 14 days.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- m-xylene
- EC Number:
- 203-576-3
- EC Name:
- m-xylene
- Cas Number:
- 108-38-3
- Molecular formula:
- C8H10
- IUPAC Name:
- m-xylene
- Details on test material:
- no further details
Constituent 1
- Specific details on test material used for the study:
- not specified
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Weight at study initiation: 2.5-3.5 kg
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Fur removed from the entire trunk by clipping and the dose retained beneath an impervious plastic film for 24 hours, after which the film was removed.
- Duration of exposure:
- 24 hours
- Doses:
- Not reported
- No. of animals per sex per dose:
- 4
- Control animals:
- not specified
- Details on study design:
- Duration of observation period following administration: 14 days
- Statistics:
- Dermal LD50 (and its fiducial range) estimated. Methods used are not detailed (probit analysis assumed).
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 12 126 mg/kg bw
- Based on:
- not specified
- Remarks on result:
- other: 14.1 mL/kg bw adjusted for density of 0.86
- Mortality:
- not specified
- Clinical signs:
- other: other: not specified
- Gross pathology:
- not specified
- Other findings:
- N/A
Any other information on results incl. tables
N/A
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 of m-xylene in the male New Zealand White rabbit was 12126 mg/kg.
- Executive summary:
The acute dermal LD50 of m-xylene in the male New Zealand White rabbit was 14.1 mL/kg bodyweight, equivalent to 12126 mg/kg.
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