1,3,2-dioxathiane 2,2-dioxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

OECD Guideline for Testing of Chemicals - Section 4: Health Effects, 423, 2001

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

1,3,2-dioxathiane 2,2-dioxide

EC Number:

214-022-5

EC Name:

1,3,2-dioxathiane 2,2-dioxide

Cas Number:

1073-05-8

Molecular formula:

C3H6O4S

IUPAC Name:

1,3,2λ⁶-dioxathiane-2,2-dione

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material: 1,3,2-dioxathiane 2,2-dioxide
- IUPAC name: 1,3,2-Dioxathiane 2,2-dioxide
- Molecular formula: C3H6O4S
- Molecular weight: 138.14 g/mol
- Substance type: Organic
- Physical state: Solid

Specific details on test material used for the study:

- Name of test material: 1,3,2-dioxathiane 2,2-dioxide
- IUPAC name: 1,3,2-Dioxathiane 2,2-dioxide
- Molecular formula: C3H6O4S
- Molecular weight: 138.14 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals

Species:

rat

Strain:

other: Rattus norvegicus

Sex:

female

Details on test animals or test system and environmental conditions:

Test animals
Nine rats female (Rattus norvegicus) young adult lineage Wistar, nulliparous and non-pregnant were used after inspection and acclimation to the laboratory conditions for 5 days.
1st Treatment
Age: 9 weeks
Weight between: 176.30 g to 189.94 g
Acquired from: ANILAB – Animais de Laboratório Criação e Comércio Ltda
Batch: 021/18

2nd Treatment
Age: 9 weeks
Weight between: 173.29 g to 200.55 g
Acquired from: ANILAB – Animais de Laboratório Criação e Comércio Ltda
Batch: 021/18

3rd Treatment
Age: 9 weeks
Weight between: 182.91 g to 197.20 g
Acquired from: ANILAB – Animais de Laboratório Criação e Comércio Ltda
Batch: 022/18

Environmental Conditions
The animals’ rooms were maintained in controlled and monitored environmental conditions during the entire study conduct for: temperature, humidity and room ventilation. Temperature and humidity data were noted in book of records.
Temperature: Min: 19.0 ºC; Max: 22.8 ºC
Humidity: Min: 41 %; Max: 69%
Light cycles: 12 hours light / 12 hours dark
Room Ventilation: 10 to 15 air changes per hour

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

300 and 2000 mg Kg-1 of body weight

No. of animals per sex per dose:

3 animals

Control animals:

not specified

Details on study design:

This acute oral toxicity study in rats (Rattus norvegicus) was carried out in order to evaluate the possible toxic effects of the test substance 1,3,2-Dioxathiane, 2,2-dioxide administered by the oral route. Nine females, divided in groups of three animals, were tested in three steps at the dose levels of 300 and 2000 mg kg-1 of body weight. The test substance was applied diluted using purified water as vehicle. The volume administered to each animal was calculated according to the body weight determined on the day of treatment. After dosing by gavage, the animals were observed during 14 days to evaluate deaths, and behavioral and clinical alterations.

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 mg/kg bw

Based on:

test mat.

Mortality:

when administered by oral route in female rats, cause deaths, for every step taken at the dose levels of 2000 mg kg-1 of body weight. 3 (all) females in the high dose group died (1 at 5.4 hours and 2 on day 1)

Clinical signs:

other: The animals were examined for death and systemic signs of toxicity with special attention during the first 4 hours after dosing and during 14 days after the test substance application. Observations included but not limited at: changes in skin and fur, eye

Gross pathology:

No test-article related changes were reported.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute oral LD50 value of the test substance 1,3,2-Dioxathiane, 2,2-dioxide was estimated to be greater than 300 mg/kg of body weight for female rats.

Executive summary:

In this guideline (OECD 423) comparable study, the test substance 1,3,2-Dioxathiane, 2,2-dioxide, when administered by oral route in female rats, cause deaths, for every step taken at the dose levels of 2000 mg kg-1 of body weight. In clinical examinations, the tested animals did not show systemic signs of toxicity. In macroscopic evaluations no alterations were observed during the necropsies. Based on the flow chart with the starting dose of 300 mg kg-1 of body weight, the test substance was classified as category 4, according to the GHS (Globally Harmonized Classification System for Chemical Substances and Mixtures). The oral LD50 value of test substance 1,3,2-Dioxathiane, 2,2-dioxide, for female rats, was estimated to be 300 mg kg-1 of body weight.