Dimethyl sulphone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Data is from peer-reviewed journal.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Toxicity of the given substance in rats

Author:

Horvath et al.

Year:

2002

Bibliographic source:

Food and Chemical Toxicology

Reference 2

Reference Type:

other: secondary database

Title:

Report on the test chemical

Author:

Food and Drug Administration

Year:

2007

Bibliographic source:

Food and Drug Administration

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute oral toxicity of the substance was assessed in Sprague-dawley rats.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl sulphone

EC Number:

200-665-9

EC Name:

Dimethyl sulphone

Cas Number:

67-71-0

Molecular formula:

C2H6O2S

IUPAC Name:

dimethyl sulphone

Details on test material:

- IUPAC Name: Dimethyl sulphone
- InChI: 1S/C2H6O2S/c1-5(2,3)4/h1-2H3
- Smiles: S(C)(C)(=O)=O
- Molecular formula:C2H6O2S
- Molecular weight:94.1334 g/mole
- Substance type:Organic
- Physical state:Solid

SOURCE OF TEST MATERIAL
- Source of test material: Cardinal Nutrition (Cardinal OptiMSMTM, Vancouver, WA, USA
- Lot/batch No.of test material: 98019

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories (Raleigh, NC, USA).
- Age at study initiation: 6 weeks old
- Weight at study initiation: 206–220 g (males), 146–165 g (females)
- Housing: housed individually in solid-bottomed polycarbonate cages lined with heat-treated hardwood chip bedding
- Diet (e.g. ad libitum): Certified Rodent Diet #5002
- Water (e.g. ad libitum): tap water public
water supply
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 69 and 750 °F
- Humidity (%): between 37 and 60%.
- Photoperiod (hrs dark / hrs light): 12-h light/dark cycle.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

sterile water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2g/kg
MAXIMUM DOSE VOLUME APPLIED: 10ml/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

10 male and 10 female rats

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were checked for clinical signs and mortality twice a day. Each rat was weighed on days 1, 5, 8, 12 and 15.
- Necropsy of survivors performed: yes, rats were sacrificed on day 15 by CO2 asphyxiation.
Necropsy examinations included a thorough inspection of all external surfaces, organs and orifices. The following organs and tissues were examined: adrenals, aorta, brain, cecum, colon, duodenum, epididymides, esophagus, eyes, heart, ileum, jejunum, kidneys, larynx, liver, lungs, lymph nodes (mesenteric, mandibular), mammary glands, ovaries, pancreas, parathyroid, prostate, rectum, salivary glands, skeletal muscle, skin, spleen, stomach (fundic area), testes, thyroid, tongue, trachea, urinary bladder, uterus and vagina.

Statistics:

not specified

Results and discussion

Preliminary study:

not specified

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality observed

Mortality:

No mortality was observed at the dose concentration of 2000 mg/kg bw.

Clinical signs:

other: No adverse effects or clinical signs of toxicity were observed for any animals dosed during the study.

Gross pathology:

No gross lesions were noted in any rats on necropsy.

Other findings:

not specified

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The acute oral LD50 value was considered to be >2000 mg/kg bw, when 10 male and 10 female Sprague-dawley rats were treated with the given test chemical via oral gavage route.

Executive summary:

The acute oral toxicity study was conducted by using the given test chemical in when 10 male and 10 female Sprague-dawley rats at the dose concentration of 0 and 2000 mg/kg bw.

The given test chemical was dissolved in sterile water and administered as 10 ml/kg via oral gavage route. The control animals received sterile water only.

Animals were checked for clinical signs and mortality twice a day. Each rat was weighed on days 1, 5, 8, 12 and 15. Necropsy of survivors performed. Rats were sacrificed on day 15 by CO2 asphyxiation. Necropsy examinations included a thorough inspection of all external surfaces, organs and orifices. The following organs and tissues were examined: adrenals, aorta, brain, cecum, colon, duodenum, epididymides, esophagus, eyes, heart, ileum, jejunum, kidneys, larynx, liver, lungs, lymph nodes (mesenteric, mandibular), mammary glands, ovaries, pancreas, parathyroid, prostate, rectum, salivary glands, skeletal muscle, skin, spleen, stomach (fundic area), testes, thyroid, tongue, trachea, urinary bladder, uterus and vagina.

No mortality was observed at the dose concentration of 2000 mg/kg bw. No adverse effects or clinical signs of toxicity were observed for any animals dosed during the study. No discernible differences in weight gain were noted between treatment groups. No gross lesions were noted in any rats on necropsy.

Under the condition of the study, the LD50 value was considered to be >2000 mg/kg bw, when 10 male and 10 female Sprague-dawley rats were treated with the given test chemical via oral gavage route.