1,3-Benzodioxole-5-carboxylic acid, 3a,6,7,7a-tetrahydro-2,2-dimethyl-7-[(methylsulfonyl)oxy]-, ethyl ester, (3aR,7R,7aR)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998-02-10 to 1998-02-24

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with minor deviations from current standard test guidelines and/or minor methodological deficiencies. However, these deviations do not adversely affect the overall conclusions or the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

yes

Remarks:

minor deviations such as age of rats at dosing

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

yes

Remarks:

minor

GLP compliance:

yes

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl (3aR,7R,7aR)-2,2-dimethyl-7-[(methylsulfonyl)oxy]-3a,6,7,7a-tetrahydro-1,3-benzodioxole-5-carboxylate

EC Number:

606-548-2

Cas Number:

204254-84-2

Molecular formula:

C13 H20 O7 S

IUPAC Name:

Ethyl (3aR,7R,7aR)-2,2-dimethyl-7-[(methylsulfonyl)oxy]-3a,6,7,7a-tetrahydro-1,3-benzodioxole-5-carboxylate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Purity 98.5%
Retest date: 17 October 1998

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Rats were ~6 weeks old at dosing. Body weight range at start of dosing M: 126.5-144.1 g, F: 102.1-115.3 g. Group size = 5 rats/sex, housed singly. Temperature 22°C ± 2°C, Relative humidity 50% +/- 10%. Lighting Fluorescent tubes, 12 hours light/dark cycle.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 5g Sodium Carboxymethylcellulose, 4 mL Tween 80, 5 mL Benzylalcohol and NaCl (0.9%) to 1 L

Details on oral exposure:

Animals were fasted overnight and access to feed was given 3 hours after dosing. Dose administered at 15 mL/kg

Doses:

The dose was selected on the basis of a preliminary toxicity study with 3 rats. The animals received a single oral administration of 500 or 2000 mg/kg. All doses were well tolerated. For the main study the dose level of 2000 mg/kg was selected.

No. of animals per sex per dose:

5 males and 5 females per dose level

Control animals:

not specified

Details on study design:

Clinical Observations and examinations:
Mortalities: Daily
Clinical symptoms: Daily
Body weight development: 2-3 times/week

Results and discussion

Preliminary study:

The animals (sex not stated) received a single oral administration of 500 or 2000 mg/kg. All doses were well tolerated.

Effect levels

Sex:

male/female

Dose descriptor:

other: Maximum Tolerated Dose

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Single-dose administration of 2000 mg/kg (by gavage) was well tolerated in the rats.
No mortalities occurred during the 14-day observation period

Clinical signs:

other: Single-dose administration of 2000 mg/kg (by gavage) was well tolerated in the rats. No uncommon clinical signs were observed during the 14-day observation period

Gross pathology:

At necropsy, no macroscopic findings were observed in any of the rats.

Other findings:

No histopathological evaluation of organs or tissues was included in this study because no uncommon clinical signs were noted during the 14-day observation period and no macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The maximum tolerated dose (MTD) in the rat after acute oral administration was more than 2000 mg/kg bw.

Executive summary:

A single-dose administration of 2000 mg/kg body weight of the test item (by gavage) was well tolerated in male and female rats. No mortalities occurred and no uncommon clinical signs were observed during the 14-day observation period. Furthermore, no macroscopic findings were noted at necropsy.

The maximum tolerated dose (MTD) in the rat after acute oral administration was more than 2000 mg/kg bw.