Registration Dossier

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
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.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1962

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
Name:
Unnamed
Type:
Constituent
Details on test material:
no further details

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals 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

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
12 126 mg/kg bw
Remarks on result:
other: 14.1 mL/kg bw adjusted for density of 0.86

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.