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Acute Toxicity: inhalation

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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 source

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Scientific Opinion on the safety assessment of carvone, considering all sources of exposure
Author:
European Food Safety Authority (EFSA)
Year:
2014
Bibliographic source:
EFSA Journal 2014;12(7):3806
Reference Type:
secondary source
Title:
Annex 1 Background document to the Opinion proposing harmonised classification and labelling at Community level of carvone
Author:
Committee for Risk Assessment RAC -ECHA
Year:
2013
Bibliographic source:
Annex 1 Background document to the Opinion proposing harmonised classification and labelling at Community level of carvone , Committee for Risk Assessment RAC -ECHA ,adopted on 4 June,2013
Reference Type:
secondary source
Title:
Proposal for Harmonised Classification and Labelling - Carvone
Author:
European Chemicals Agency (ECHA)
Year:
2012
Bibliographic source:
Proposal for Harmonised Classification and Labelling – Carvone, European Chemicals Agency (ECHA), 21 September 2012
Reference Type:
secondary source
Title:
Review report for the active substance carvone
Author:
COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL,Standing Committee on the Food Chain and Animal Health
Year:
2008
Bibliographic source:
Review report for the active substance carvone Finalised in the Standing Committee on the Food Chain and Animal Health, in view of the inclusion of carvone in Annex I of Directive 91/414/EEC,22 January 2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
Acute inhalation toxicity study of 2-Methyl-5-(1-methylethenyl)-2-cyclohexenone (99-49-0) in rats according to OECD Guideline 403 (Acute Inhalation Toxicity).
GLP compliance:
not specified
Test type:
other: no data available
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
D-p-mentha-1(6),8-dien-2-one
EC Number:
202-759-5
EC Name:
D-p-mentha-1(6),8-dien-2-one
Cas Number:
99-49-0
Molecular formula:
C10H14O
IUPAC Name:
(5R)-2-Methyl-5-prop-1-en-2-ylcyclohex-2-en-1-one
Test material form:
liquid
Details on test material:
- Name of test material (IUPAC name): 2-Methyl-5-(1-methylethenyl)-2-cyclohexenone- Common name: Carvone- Molecular formula: C10H14O- Molecular weight: 150.2196 g/mol- Smiles notation: CC(=C)C1CC=C(C)C(=O)C1- InChl: 1S/C10H14O/c1-7(2)9-5-4-8(3)10(11)6-9/h4,9H,1,5-6H2,2-3H3- Substance type: Organic- Physical State: Liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report):2-Methyl-5-(1-methylethenyl)-2-cyclohexenone- Molecular formula :C10H14O- Molecular weight :150.2196 g/mol- Substance type:organic

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data available

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
not specified
Remark on MMAD/GSD:
No data available
Details on inhalation exposure:
No data available
Remarks on duration:
No data available
Concentrations:
5.66 mg/l in air (5660 mg/m3)
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
Details on study design:- Necropsy of survivors performed: yes- Other examinations performed: clinical signs
Statistics:
No data available

Results and discussion

Preliminary study:
No data available
Effect levels
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 5.66 mg/L air
Based on:
test mat.
Remarks on result:
other: No 50% mortality was observed at dose 5.66 mg/l(5660 mg/m3)
Mortality:
One female died the day after the exposure.
Clinical signs:
other: During exposure a decreased breathing frequency, and less frequently, post-inspiratory apnoea and superficial breathing were observed.After exposure and increased breathing frequency,post-inspiratory apnoea and dyspnoea were seen. Clinical signs during ex
Body weight:
Body weight gain was impaired in most rats during the first week after treatment. Normal body weight gain was observed in the second week, except for two females that showed only marginal body weight gain.
Gross pathology:
Gross Pathology revealed no abnormalities, except in the female that died the day after exposure: dark foamy lungs, light coloured liver and air-filled stomach and intestines were observed.
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Conclusions:
The LC50 value for acute inhalation toxicity test was considered to be >5.66 mg/l in air (5660 mg/m3),when rats were exposed with 2-Methyl-5-(1-methylethenyl)-2-cyclohexenone (99-49-0) by inhalation according to OECD Guideline 403 (Acute Inhalation Toxicity).
Executive summary:

In acute inhalation toxicity study, rats were exposed to 2-Methyl-5-(1-methylethenyl)-2-cyclohexenone(99-49-0)in the concentration of 5.66 mg/l in air (5660 mg/m3) inhaled as a Single dose. One female died the day after the exposure. During exposure a decreased breathing frequency, and less frequently, post-inspiratory apnoea and superficial breathing were observed. After exposure and increased breathing frequency, post-inspiratory apnoea and dyspnoea were seen. Clinical signs during exposure were restlessness and stress and in coordination and tremors. A dirty and wet fur was observed 24-48h after treatment. Alopecia was observed in a few rats at days 7-13. Body weight gain was impaired in most rats during the first week after treatment. Normal body weight gain was observed in the second week, except for two females that showed only marginal body weight gain.GrossPathology revealed no abnormalities, except in the female that died the day after exposure: dark foamy lungs, light coloured liver and air-filled stomach and intestines were observed.

Therefore, LC50 value was considered to be >5.66 mg/l in air (5660 mg/m3), when rats were exposed with 2-Methyl-5-(1-methylethenyl)-2-cyclohexenone (99-49-0) by inhalation according to OECD Guideline 403 (Acute Inhalation Toxicity).