Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
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:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

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

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Abies Sibirica Oil

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 details
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
Total: 10 animals
Control animals:
no
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:
None
Effect levels
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:
- Slightly flaccid muscle tone was observed on Day 1
- Diarrhea and ptosis were observed in some animals from Days 1-3.
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 Abies Sibirica Oil is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Regulation (EC) N° 1272-2008.
Executive summary:

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

No mortality was observed. Slightly flaccid muscle tone was observed on Day 1. Diarrhea and ptosis were observed in some animals from Days 1-3. In this study, the oral LD50 of Abies Sibirica Oil was higher than 5000 mg/kg bw in rats.

Under the test conditions, oral LD50 of Abies Sibirica Oil is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the Regulation (EC) N° 1272-2008.