Propanoic acid, 2-hydroxy-, (1R,2S,5R)-5-methyl-2-(1-methylethyl)cyclohexyl ester, (2S)-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed under GLP conditions according to OECD and EU guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Menthyl lactate

IUPAC Name:

Menthyl lactate

Constituent 2

Reference substance name:

Methyl lactate

EC Number:

208-930-0

EC Name:

Methyl lactate

Cas Number:

547-64-8

IUPAC Name:

methyl 2-hydroxypropanoate

Constituent 3

Reference substance name:

Propanoic acid, 2-hydroxy-, (1R,2S,5R)-5-methyl-2-(1-methylethyl)cyclohexyl ester, (2S)-

EC Number:

612-179-8

Cas Number:

61597-98-6

Molecular formula:

C13H24O3

IUPAC Name:

Propanoic acid, 2-hydroxy-, (1R,2S,5R)-5-methyl-2-(1-methylethyl)cyclohexyl ester, (2S)-

Details on test material:

Menthyl lactate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin & Klingman Ltd.
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: male: 201-230g, female 200 - 227g
- Fasting period before study: not reported
- Housing: solid-floor polypropylene cages with sawdust bedding
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24°C
- Humidity (%): 40 - 56%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12h dark / 12 h light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: skin of the back and flanks, totalling about 10% of the total body surface area
- % coverage: semi-occlusive, not specified
- Type of wrap if used: self-adhesive bandage (HYPERTIE)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated skin and surrounding hair was wiped with cotton wool moistened with distilled water
- Time after start of exposure: 24 hours after application following removal of cover

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not reported
- Concentration (if solution): not applicable

VEHICLE
- no vehicle used

Duration of exposure:

24 hours of semi-occlusive skin contact

Doses:

10 g/kg bw of undiluted Menthyl lactate was applied onto skin area of about 4 x 5 cm

No. of animals per sex per dose:

5 male and 5 female rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations for overt signs of toxicity and death: 1 and 4 hours after dosing, at least once daily for 14 days
- Body weight: individual body weights were recorded on the day of treatment and on days seven and fourteen
- Necropsy of survivors performed: all animals were subjected to a gross necropsy examination for any macroscopic abnormalities
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal died during the study period.

Clinical signs:

other: No evidence of systemic toxicity or skin irritation was noted during the observation period of 14 days.

Gross pathology:

No abnormalities were noted at necropsy of animals killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal median lethal dose (LD50) of the test material, Menthyl lactate, to Sprague-Dawley rats was found to be greater than 10 g/kg bodyweight. The substance is not classified according to CLP.

Executive summary:

The acute dermal toxicity of the test material in the Sprague-Dawley rat was determined according to the OECD Guideline for Testing of Chemicals (1981) No. 402 "Acute Dermal Toxicity" with a group of ten animals (five males and five females).

A single, 24-hour, semi-occluded dermal application of the test material to intact skin, at a dose level of 10 g/kg bodyweight was given. Animals were observed for a period of 14 days after application. There were no deaths, no evidence of systemic toxicity or skin irritation and no toxicologically significant effects on bodyweight noted during the study period. Also no abnormalities were noted at necropsy of animals killed at the end of the study.

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley rat was found to be greater than 10 g/kg bodyweight.