Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study performed equivalent or similar to OECD 402, but pre-GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
pre-GLP
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): Spearmint oil
- Physical state: liquid
- Purity: no data
- Lot/batch No.: Confidential information

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
No data available
Duration of exposure:
No data
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 (one dose, unspecified sex)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs and skin irritation
Statistics:
Not relevant

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 3/10 animals died at 5000 mg/kg bw
Mortality:
Mortality was seen in 3 out of 10 animals. The animals died on day 2,4 and 6.
Clinical signs:
Hypothermia and ataxia was observed in 2 out of 3 rabbits that died. Moderate redness and edema was seen in all test animals.
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Based on CLP criteria
Conclusions:
Under the conditions of this test, an LD50 greater than 5000 mg/kg bw was found. Based on this result, the test substance does not need to be classified for acute dermal toxicity in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP).
Executive summary:

A dermal toxicity test was performed on 10 rabbits according to a method similar to OECD402. A single dose of 5000 mg/kg bw was used. Mortality, clinical signs and skin irritation were observed for 14 days.

Three out of 10 animals died during the observation period on day 2, 4 and 6. Hypothermia and ataxia was observed in 2/3 animals which died. Moderate redness and edema was observed in all animals.

In conclusion, an LD50 of >5000 mg/kg bw was established and therefore the test substance does not need to be classified for acute dermal toxicity in accordance to the criteria outlined in Annex I of 1272/2008/EC (CLP).