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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
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:
1972
Report date:
1972

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:
Fir, Abies alba, ext.
EC Number:
289-870-2
EC Name:
Fir, Abies alba, ext.
Cas Number:
90028-76-5
IUPAC Name:
Fir, Abies alba, ext.
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Abies alba oil from needles
- Physical state: Clear liquid

Test animals

Species:
rat
Strain:
other: Sherman-Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Fasting period before study: Animals were fasted for 24 h prior to administration of the test item
- Diet: Food, ad libitum
- Water: Water, ad libitum
- Acclimation period: 1 week

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 animals/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed for mortality and clinical signs daily for 14 days
- Necropsy of survivors performed: No data
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
male/female
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:
- Animals were lethargic soon after dose administration and full recovery was observed 24 h later.
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:
GHS criteria not met
Conclusions:
Under the test conditions, oral LD50 of Abies alba oil from needles 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), groups of Sherman-Wistar rats (5/sex/dose) were given a single oral dose of Abies alba oil from needles at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs daily for 14 days.

No mortality was observed. Animals were lethargic soon after dose administration and full recovery was observed 24 h later. In this study, the oral LD50 of Abies alba oil from needles was higher than 5000 mg/kg bw in rats.

 

Under the test conditions, oral LD50 of Abies alba oil from needles 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.