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Toxicological information

Acute Toxicity: dermal

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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:
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 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:
No
Body weight:
No data
Gross pathology:
No data
Other findings:
None

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.

Reason / purpose:
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:
reference to same study
Reason / purpose:
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

None

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.

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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): l-limonene

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals 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:
No
Body weight:
No data
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).