Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
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:
Standard acute method (limit test)
GLP compliance:
no
Remarks:
(pre-GLP)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Pine, Pinus sylvestris, ext.
EC Number:
281-679-2
EC Name:
Pine, Pinus sylvestris, ext.
Cas Number:
84012-35-1
IUPAC Name:
Pine, Pinus sylvestris, ext.
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Pinus Oil Sylvestris

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system 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:
Total: 10 animals
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Observations for mortality and toxic effects were made daily for 14 days
- Necropsy of survivors performed: No data
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed
Mortality:
No mortality was observed.
Clinical signs:
No clinical signs were observed.
Body weight:
No data
Gross pathology:
No data
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, oral LD50 of Pinus Oil Sylvestris is higher than 5000 mg/kg bw in rats therefore it must not be classified according to the CLP Regulation (EC) No. 1272/2008 and Globally Harmonized System (GHS).
Executive summary:

In an acute oral toxicity study (limit test), ten rats were given a single oral dose of Pinus Oil Sylvestris at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days.

No mortality and clinical signs were observed. In this study, the oral LD50 of Pinus Oil Sylvestris was higher than 5000 mg/kg bw in rats.

Under the test conditions, oral LD50 of Pinus Oil Sylvestris is higher than 5000 mg/kg bw in rats therefore it must not be classified according to the CLP Regulation (EC) No. 1272/2008 and Globally Harmonized System (GHS).

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.