Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary database

Data source

Reference
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:
The toxicity study was conducted to evaluate the acute toxic effects of administration of the given test chemical in rat by the inhalation route.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material: Methane, 1,1'-sulfonylbis-
- Molecular formula: C2-H6-O2-S
- Molecular weight: 94.1334 g/mol
- Smiles: S(C)(C)(=O)=O
- Inchi: 1S/C2H6O2S/c1-5(2,3)4/h1-2H3
- Substance type: Organic
- Physical state: solid

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)BR
Sex:
male/female
Details on test animals and environmental conditions:
not specified

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
nose only
Vehicle:
other: water
Remark on MMAD/GSD:
not specified
Details on inhalation exposure:
VEHICLE
- Concentration of test material in vehicle (if applicable): MSM was administered as a 16% solution in water by the intranasal route at a dose of 0.6 ml/kg.
Analytical verification of test atmosphere concentrations:
not specified
Remarks on duration:
Acute study but duration is not reported.
Concentrations:
0.6 ml/kg (600 mg/kg)
No. of animals per sex per dose:
5 per sex
Control animals:
not specified
Details on study design:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology.
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 600 mg/L air
Based on:
test mat.
Remarks on result:
other: Intranasal administration of MSM did not induce mortality, signs of toxicity or local irritation reactions.
Mortality:
No deaths were noted.
Clinical signs:
No general/local clinical changes were noted.
Body weight:
No body weight growth abnormalities were noted.
Gross pathology:
No treatment-related changes were noted.
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The acute lethal concentration (LC50) of the given test chemical in rat was considered to be >600 mg/L.
Executive summary:

The toxicity study was conducted to evaluate the acute toxic effects of administration of the given test chemical in Crl:CD(SD)BR rat (n = five per sex) by the inhalation route.

The given test chemical was administered as a 16% solution in water by the intranasal route at a dose of 0.6 ml/kg to six male rats. Clinical observations, body weight determinations and gross pathology examinations were conducted. A detailed post-mortem examination, including gross pathology and histology was performed on nasal turbinate.

No deaths or general/local clinical changes or body weight growth abnormalities were noted. At the post-mortem examinations, no treatment-related changes were noted. It is concluded that intranasal administration of test chemical did not induce mortality, signs of toxicity or local irritation reactions.

Thus, based on the results obtained from present investigation, it can be concluded that test compound is acutely non toxic to rats at the tested concentration of 600 mg/L. The acute lethal concentration (LC50) of test chemical was considered to be >600 mg/L.

Thus, according to CLP criteria for acute toxicity rating for the chemicals, the test compound can be classifying under acutely non toxic compound at the tested dose levels.