Registration Dossier
Registration Dossier
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EC number: 227-815-6 | CAS number: 5989-54-8
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1975
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Study performed similarly to OECD guideline 402 with deviations: no data about purity of the test substance; no data on source of animals and environmental conditions; bodyweights not recorded
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- 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
- Principles of method if other than guideline:
- Standard acute method (limit test)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- None
- 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
- Preliminary study:
- Not applicable
- 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
- 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.
None
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1975
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- Method followed unknown
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Duration of treatment / exposure:
- No data
- Observation period:
- No data
- Number of animals:
- 10
- Remarks on result:
- other: moderate redness: 3/10 animals; moderate edema: 6/10 animals
- Other effects:
- No data
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the test conditions, topical application of l-limonene resulted in moderate redness and moderate edema in 3/10 and 6/10 animals, respectively.
- Executive summary:
In a primary dermal irritation study, ten rabbits were dermally exposed to l-limonene.
Under the test conditions, moderate redness and moderate edema was observed in 3/10 and 6/10 animals, respectively.
None
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:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- None
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- None
- Duration of exposure:
- no data
- 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, clinical signs of toxicity and dermal reactions 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:
- - Dermal reactions: moderate redness (3/10 rabbits) and moderate edema (6/10 rabbits)
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 dermal LD50 for l-limonene is higher than 5000 mg/kg bw in rabbits therefore it is not classified according to the CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In an acute dermal toxicity study, 10 rabbits were administered a single dermal 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. Dermal reactions noted were moderate redness (3/10 rabbits) and moderate edema (6/10 rabbits) at the site of application.
The dermal LD50 for l-limonene is higher than 5000 mg/kg bw in rabbits therefore it is not classified according to the CLP Regulation (EC) N° (1272-2008).
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