Registration Dossier
Registration Dossier
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EC number: 227-815-6 | CAS number: 5989-54-8
Acute Toxicity: oral
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:
- 1 975
- 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
- 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
Constituent 1
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:
- other: No
- 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.
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