Registration Dossier

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
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 oral toxicity: 10 animals/dose by oral gavage
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:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days


Statistics:
No data

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
1/10 animals died on Day 7
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data
Other findings:
No data

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 oral LD50 for beta-pinene was found to be greater than 2000 mg/kg bw in the rats and therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.
Executive summary:

In an oral acute toxicity study performed in a group of 10 rats, received a single oral dose of beta-pinene at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs of toxicity for 14 days.

No toxicity was observed except death of one animal on Day 7. The oral LD50 was considered to be greater than 5000 mg/kg/bw.

The oral LD50 for beta-pinene was found to be greater than 2000 mg/kg bw in the rats and therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.