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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

Administrative data

Description of key information

Oral:

Moreno, 1976: Similar to OECD 401, non-GLP, LD50: ca. 5000 mg/kg bw (Rat)

Dermal:

Moreno, 1976: Similar to OECD 402, non-GLP, LD50 > 5000 mg.kg bw (Rabbit)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
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 401, and not according to GLP guidelines.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substance Act (FHSA)
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
CAS 8008-79-5
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: Approx. 200 g
- Fasting period: 16 - 18 hours
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
No data available
Doses:
5000 mg/kg
No. of animals per sex per dose:
10 rats (male)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily (and frequently on day of test)
- Necropsy of survivors performed: no
- Other examinations performed: symptomatology
Statistics:
not relevant
Preliminary study:
Not relevant
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Mortality:
5 / 10
Clinical signs:
other: Piloerection in 7/10 rats, lethargy at 24 hours in 5/10 rats
Gross pathology:
not performed
Other findings:
Necropsy was not performed

Not relevant

Interpretation of results:
other: Not classified
Remarks:
Based on CLP criteria
Conclusions:
The oral LD50 value of Spearmint Oil in rats was established as approximately 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).
Executive summary:

A single 5000 mg/kg bw dose of Spearmint Oil was administered by oral gavage to 10 male Wistar albino rats. The animals were observed for 14 days while food and water were available ad libitum. Mortality was observed in 5/10 rats and the following symptoms were observed: Piloerection in 7/10 rats, lethargy at 24 hours in 5/10 rats. The oral LD50 value of Spearmint Oil in rats was established as approximately 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not have to classified according to the classification criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Study performed equivalent or similar to OECD 401, and not according to GLP guidelines.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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.
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
Specific details on test material used for the study:
TSCA-CAS No.: 8008-79-5
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data available
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
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
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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
Study performed equivalent or similar to OECD 402, but pre-GLP.

Additional information

Oral

Moreno, 1976: A single 5000 mg/kg bw dose of Spearmint Oil was administered by oral gavage to 10 male Wistar ablino rats. The animals were observed for 14 days while food and water were available ad libitum. Mortality was observed in 5/10 rats and the following symptoms were observed: Piloerection in 7/10 rats, lethargy at 24 hours in 5/10 rats. The oral LD50 value of Spearmint Oil in rats was established as approximately 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not have to classified according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).

Dermal

Moreno, 1976: 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).

Justification for classification or non-classification

The substance is not classified for acute toxicity according to Regulation 1272/2008/EC (CLP).