Registration Dossier
Registration Dossier
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EC number: 233-546-5 | CAS number: 10226-30-9
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Sensory irritation and pulmonary irritation of n-methyl ketones: receptor activation mechanisms and relationships with threshold limit values
- Author:
- Lea Frimann Hansen, Gunnar Damghrd Nielsen
- Year:
- 1 994
- Bibliographic source:
- Arch Toxicol (1994) 68:193-202
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The acute inhalation study was performed on CF1 male mice exposed for 10 mins by chemical methyl hexyl ketone
- GLP compliance:
- no
- Test type:
- standard acute method
Test material
- Reference substance name:
- Octan-2-one
- EC Number:
- 203-837-1
- EC Name:
- Octan-2-one
- Cas Number:
- 111-13-7
- IUPAC Name:
- octan-2-one
- Reference substance name:
- Methyl hexyl ketone
- IUPAC Name:
- Methyl hexyl ketone
- Details on test material:
- - Name of test material (as cited in study report): Methyl hexyl ketone
- Molecular formula (if other than submission substance): C8H16O
- Molecular weight (if other than submission substance): 128.2134
- Substance type: Organic
- Physical state: Liquid
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- - Source: Statens Seruminstitut, Denmark
- Age at study initiation: No data available
- Weight at study initiation: 26.3 g (SD 2.9 g)
- Fasting period before study:
- Housing: wire mesh cages placed inside polycarbonate (Macrolone) cages with sawdust bedding
- Diet (e.g. ad libitum): standard diet (Altromin no. 1324).
Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period:
Administration / exposure
- Route of administration:
- other: inhalation without cannula
- Type of inhalation exposure:
- not specified
- Vehicle:
- air
- Details on inhalation exposure:
- No data available
- Duration of exposure:
- 10 min
- Concentrations:
- 0, 17.9 and 27 ppm/min
- No. of animals per sex per dose:
- 9 mice
- Control animals:
- yes
- Details on study design:
- No data available
- Statistics:
- No data available
Results and discussion
- Preliminary study:
- No data available
Effect levels
- Sex:
- male
- Dose descriptor:
- other: decrease in respiratory rate RD0 with 95% concentration limits and slope function with 95% concentration limits
- Effect level:
- 75 mg/L air
- Based on:
- test mat.
- 95% CL:
- 13 - 412
- Exp. duration:
- 2 min
- Remarks on result:
- other: For 0-2 minutes RD0- 115 (33-395)ppm; slope function - 30.0 (11-49) , Mean for 11-20 min RD0 - 75 (13-412)ppm; slope function - 30.2 (8-52)
- Mortality:
- No mortality observed.
- Clinical signs:
- other: 50 % decrease in respiratory rate was observed in treated mice.
- Body weight:
- No data available
- Gross pathology:
- No data available
- Other findings:
- No data available
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The RD0 was found to be 115 (33-395) and 75 (13-412) ppm with duration of 0-2 and 11-20 mins respectively when exposed to male mice by chemical methyl hexyl ketone.
- Executive summary:
In a acute inhalation toxicity study,CF-1 male mice were treated with Methyl hexyl ketoneinhaled by air in the concentration of 0, 17.9 and 27 ppm/min. No mortality was observed in treated mice 50 % decrease in respiratory rate was observed in treated mice. Therefore, RD0 was considered to be 115 (33-395) and 75 (13-412) ppm with duration of 0-2 and 11-20 min when CF-1 male mice were treated withMethyl hexyl ketone inhaled by air.
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