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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
Study period:
1975
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Test method and results not sufficiently detailed
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method according to the typical testing for acute dermal toxicity in a limit test: topical application of substance on rabbits at selected doses.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): beta-pinene

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
no data
Duration of exposure:
No data
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
no data
Statistics:
None

Results and discussion

Preliminary study:
None
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
Vocalization was observed in 8/10 animals
Body weight:
no data
Gross pathology:
no data
Other findings:
- Slight redness: 6/10
- Moderate redness: 2/10
- Moderate edema: 10/10

Any other information on results incl. tables

None

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 beta-pinene is greater than 2000 mg/kg bw in rabbits and therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.
Executive summary:

In an acute dermal toxicity study of beta-pinene performed in 10 rabbits, administered a single dermal dose of beta-pinene at 5000 mg/kg bw. All animals were observed for mortality and clinical signs of toxicity.

No mortality occurred at the tested dose level. Slight and moderate redness was observed in six and two animals, respectively. Moderate edema was observed in all tested animals. Vocalization occurred in eight rabbits at the tested dose level. The dermal LD50 of β-pinene was considered to be 5000 mg/kg bw.

The acute dermal LD50 of beta-pinene is greater than 2000 mg/kg bw in rabbits and therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.