Registration Dossier

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:
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. certificate)
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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, eyes and mucous membranes alteration in respiratory, circulatory, autonomic and central nervous system and somatomotor activity. Particular attention was done to apparition of convulsions, salivation, lethargy, tremors, diarrhea, coma and death. All observations were registers.

In clinical examinations, the tested animals did not show systemic signs of toxicity
Body weight:
the difference between final and initial weight, there a little increse, the increased weights between the animals in a test group varied, but not exceeded the initial average weight of 25%.
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.