1,3-Oxathiolane-2-carboxylic acid, 5-hydroxy-, (1R,2S,5R)-5-methyl-2-(1-methylethyl)cyclohexyl ester, (2R,5R)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05.02.2004 to 16.03.2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed according to the OECD guideline 425 and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

OS Menthol Ester

IUPAC Name:

OS Menthol Ester

Constituent 2

Reference substance name:

(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl (2R,5R)-5-hydroxy-1,3-oxathiolane-2-carboxylate

EC Number:

604-569-1

Cas Number:

147126-62-3

Molecular formula:

C14H24O4S

IUPAC Name:

(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl (2R,5R)-5-hydroxy-1,3-oxathiolane-2-carboxylate

Test material form:

other: White solid

Test animals

Species:

rat

Strain:

other: CD(R)[Crt:CD(R)(SD)BR]

Sex:

female

Details on test animals or test system and environmental conditions:

- Age at study initiation: X days (at study initiation / at test item administration)
- Weight at study initiation: females 200-300 g
- Fasting period before study: overnight
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 23 days
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 1% methyl cellulose in water

Details on oral exposure:

The animals were dosed at 2000.0 mg/kg (10.0 mL/kg by volume). The individual doses of the test article preparation were individually calculated for each animal based on the body weight of the animal. All doses were administered orally using a feeding needle, inserted into the stomach of the animals.

Doses:

The individual doses of the test article will be individually calculated for each animal based on the body weight of the animal. All doses will be administered orally using No. 6 infant feeding cannula or feeding needle, inserted into the stomach of the animals. The maximum dose volume will not exceed 2 mL/100 g
for aqueous solutions, or 1 mL/1 00 g for non aqueous solutions.

No. of animals per sex per dose:

5 female rats at 2000 mg/kg

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: at 0.5 and 4 h after dosing and once daily thereafter
- Frequency of weighing: day 0 (prior to dosing), day 7 day 13 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: gross examination of organs at necropsy, organ weights, histopathology

Statistics:

Not applicable due to no mortalities.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortalities at 2000 mg/kg bw

Mortality:

No mortalities were observed during the 14-day post treatment observation period.

Clinical signs:

other: No signs of toxicity were recorded during the 14-day post treatment observation period.

Gross pathology:

Each animal was sacrificed at the end of the 14-day observation period, and full gross necropsy was performed. No gross pathological findings were observed at the time of necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information > 2000 with no deaths or evident toxicity Criteria used for interpretation of results: EU

Conclusions:

Based on the foregoing results, the acute oral LD50 in rats of the test article, OS Menthol Ester was found to be in excess of 2000.0 mg/kg.
Thus, the test article is considered not to present a sigoificant acute toxic risk if swallowed.
The Globally Harmonized Classification System for Chemicals and Mixtures classifies compounds in which the estimated LDso is greater than 2000.0 mg/kg with no deaths or evidence of toxicity as being Category 5 chemicals.

Executive summary:

As no mortalities were observed in female rats orally dosed at 2000 mg/kg bw the substance was not classified.