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Toxicological information

Acute Toxicity: oral

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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

Referenceopen allclose all

Reference Type:
publication
Title:
Toxicity of the given substance in rats
Author:
Horvath et al.
Year:
2002
Bibliographic source:
Food and Chemical Toxicology
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
No adverse effects or clinical signs of toxicity were observed for any animals dosed during the study.
Body weight:
No discernible differences in weight gain were noted between treatment groups.
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.