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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 guidelineopen allclose all
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
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

Constituent 1
Chemical structure
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.