(±)-neomenthol

Acute Toxicity: oral

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

Test material information

Constituent 1

Reference substance name:

Menthol

EC Number:

201-939-0

EC Name:

Menthol

Cas Number:

89-78-1

Molecular formula:

C10H20O

IUPAC Name:

2-isopropyl-5-methylcyclohexanol

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.