Registration Dossier
Registration Dossier
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EC number: 200-665-9 | CAS number: 67-71-0
Acute Toxicity: inhalation
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:
- 2 007
- 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:
- 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 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
- 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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)BR
- Sex:
- male/female
- Details on test animals or test system 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:
- other: 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.
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