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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
No study period is specified in the report, but the study report was finalized on 1974-06-27.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Only a short description of the study is given in the present report and few experimental details are provided. Study was conducted before the implementation of GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The acute oral toxicity of racemic menthol was determined in female Wistar rats (n=10 per dose). The test item (10-20 mL/kg) was applied by gavage at dose levels of 2; 2.,5, 3; and 3.5 g/kg bw in peanut oil. The animals were observed for 14 d post-dose. LD50 values were calculated from the experimental data using Probit analysis.
GLP compliance:
no
Remarks:
The study was conducted before the implementation of GLP.
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
peanut oil
Details on oral exposure:
The animals received a single oral dose of the test item via gavage. The test item was administered in peanut oil.
Doses:
The test item was administered at dose levels of 2; 2.5, 3; and 3.5 g/kg bw.
No. of animals per sex per dose:
10 females were used per dose.
Control animals:
no
Details on study design:
Female Wistar rats (n=10 per dose) received a single oral dose dose of the test item in peanut oil item via gavage. The test item was administered at dose levels of 2; 2.5, 3; and 3.5 g/kg bw. The animals were observed for 14 d post-dose. LD50 values were calculated from the experimental data using Probit analysis.
Statistics:
LD50 values were calculated from the experimental data using Probit analysis.

Results and discussion

Preliminary study:
no preliminary study
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
2 602 mg/kg bw
Based on:
test mat.
95% CL:
> 2 328 - < 2 861
Mortality:
Please, see section "Any other information on results incl. tables" for the mortality rates observed at the different dose levels. In the animals that died, death occurred within 1 to 3 d after administration of the test item.
Clinical signs:
1-3 days after application animals were in a narcosis-like state.
Body weight:
no data
Gross pathology:
no data
Other findings:
no data

Any other information on results incl. tables

Table 1: Acute toxicity of "Menthol racemisch 100" in female rats

Dose (g/kg)

No. of animals used

No. of animals that died

2

10

1

2.5

10

4

3

10

7

3.5

10

10

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In this acute oral toxicty study in female Wistar rats, the LD50 of menthol was determined as 2.602 g/kg bw (range: 2.328-2.861 g/kg bw). Accordingly, the acute toxicity of the test item can be considered low.
Executive summary:

In an acute oral toxicity study in female Wistar rats (n=10 per dose), menthol was administered by gavage at dose levels of 2; 2.5, 3; and 3.5 g/kg bw in peanut oil. The animals were observed for 14 d post-dose. LD50 values were calculated from the experimental data using Probit analysis.

The LD50 of menthol was determined as 2.602 g/kg bw (range: 2.328 -2.861 g). Accordingly, the acute toxicity of the test item can be considered low.