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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1975
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

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

Materials and methods

Principles of method if other than guideline:
Standard acute method (limit test)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(S)-p-mentha-1,8-diene
EC Number:
227-815-6
EC Name:
(S)-p-mentha-1,8-diene
Cas Number:
5989-54-8
Molecular formula:
C10H16
IUPAC Name:
4-isopropenyl-1-methylcyclohexene
Details on test material:
- Name of test material (as cited in study report): l-limonene

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
None

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
None
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals
Control animals:
not specified
Details on study design:
Animals were observed for mortality and clinical signs of toxicity for 14 days.
Statistics:
No data

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.
Mortality:
No mortality was observed.
Clinical signs:
No
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
Remarks:
CLP Implementation.
Conclusions:
The oral LD50 for l-limonene is higher than 5000 mg/kg bw in rats therefore it is not classified according the CLP Regulation (EC) N° 1272/2008.
Executive summary:

In an acute oral toxicity study, 10 rats were given a single oral dose of l-limonene at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs of toxicity for 14 days. No deaths and clinical signs of toxicity occurred during the observation period.

 

The oral LD50 for l-limonene is higher than 5000 mg/kg bw in rats therefore it is not classified according to the CLP Regulation (EC) N° 1272 /2008.