L-menthan-3-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

No study period is specified in the report, but the report was finalized on 1974-04-29.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Only a short description of the study is gven in the present report and few experimental details are provided. The study was not conducted according to any guideline and did not follow the rules of GLP, as it was performed prior to the implementation of GLP.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

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 the test item, "d-menthol dest." 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 1, 1.5, 2, 2,5, and 3 g/kg 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:

not specified

Remarks:

The study was performed prior to the implementation of GLP.

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

d-menthol dest.

IUPAC Name:

d-menthol dest.

Constituent 2

Reference substance name:

(+)-menthol

EC Number:

239-387-8

EC Name:

(+)-menthol

Cas Number:

15356-60-2

Molecular formula:

C10H20O

IUPAC Name:

(1S,2S,5R)-5-methyl-2-propan-2-ylcyclohexan-1-ol

Details on test material:

No details were provided.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

no data

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 1, 1.5, 2, 2,5, and 3 g/kg.

No. of animals per sex per dose:

10 female animals 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 1, 1.5, 2, 2,5, and 3 g/kg.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:

2 046 mg/kg bw

95% CL:

> 1 777 - 2 303

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 2 d after administration of the test item.

Clinical signs:

other: Animals were in a narcosis-like state.

Gross pathology:

no data

Other findings:

no data

Any other information on results incl. tables

Table 1: Acute toxicity of "d-menthol dest." in rats

Dose (g/kg)	No. of animals used	No. of animals that died
1	10	0
1.5	10	1
2	10	5
2.5	10	7
3	10	10

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In this acute oral toxicity study in female Wistar rats, the LD50 of "d-menthol dest." was determined as 2.046 g (range: 1.777-2.303 g). Accordingly, the acute toxicity of the test item in rats after oral administration can be considered low.

Executive summary:

In an acute oral toxicity study in female Wistar rats (n=10 per dose), "d-menthol dest." was administered by gavage at dose levels of 1, 1.5, 2, 2,5, and 3 g/kg 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 "d-menthol dest." was determined as 2.046 g/kg (range: 1.777-2.303 g). Accordingly, the acute toxicity of the test item in rats after oral administration can be considered low.