Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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
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

1
Reference substance name:
Essential oil of Spearmint obtained from the aerial part of Mentha spicata and/or Mentha cardiaca (Lamiaceae) obtained by distillation
EC Number:
946-253-9
Molecular formula:
Not applicable
IUPAC Name:
Essential oil of Spearmint obtained from the aerial part of Mentha spicata and/or Mentha cardiaca (Lamiaceae) obtained by distillation
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
Specific details on test material used for the study:
TSCA-CAS No.: 8008-79-5

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system 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:
other: Hypothermia and ataxia was observed in 2 out of 3 rabbits that died. Moderate redness and edema was seen in all test animals.
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).