Registration Dossier
Registration Dossier
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EC number: 613-816-2 | CAS number: 6553-64-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 February to 21 March 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Study conducted in compliance with OECD Guideline 423 without any deviation but not under GLP.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- 6,6-dimethylcyclohex-2-en-1-one
- EC Number:
- 613-816-2
- Cas Number:
- 6553-64-6
- Molecular formula:
- C8H12O
- IUPAC Name:
- 6,6-dimethylcyclohex-2-en-1-one
- Test material form:
- liquid
- Details on test material:
- Batch No.: LF 375 067
Purity: > 98%
Name of test material (as cited in study report): DIMETHYL-6,6-CYCLOHEXEN-2-ONE-1
Physical state: yellow liquid
Storage temperature: ambient temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier, Le Genest-Saint-Isle, France
- Weight at study initiation: 192-235 g
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20-23°C
- Humidity: 30-53 %
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2000 mg/kg bw
300 mg/kg bw - No. of animals per sex per dose:
- - Batch 1 (control): 6 rats females
- Batch 2 (2000 mg/kg): 3 rats females
- Batch 3 (300 mg/kg): 6 rats females - Control animals:
- yes
- Statistics:
- None
Results and discussion
- Preliminary study:
- Not Applicable
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed at dose 300 mg/kg bw
Death was observed for the 3 rats treated at dose 2000 mg/kg bw - Clinical signs:
- No clinical signs related to the administration of the test item were observed at dose 300 mg/kg bw.
A reduction in spontaneous activity, muscle tone and righting reflex were observed during the first hours of the treatment for the animals treated at 2000 mg/kg bw. - Body weight:
- Body weight gain of the treated animals was not affected by test item at dose 300 mg/kg bw
- Gross pathology:
- At 2000 mg/kg bw, red coloration was observed in the fundic mucosa of the stomach. At 300 mg/kg bw, white thickening of the ventricular mucosa was observed in the stomach.
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 for 6,6-DIMETHYL-2-CYCLOHEXENONE is 500 mg/kg bw in female rats therefore it is classified in category 4 (H302) according to CLP Regulation (EC) No 1272/2008.
- Executive summary:
In an acute oral toxicity study performed according to OECD Guideline 423 (using acute toxic class method), Sprague Dawley female rats were treated with two doses, 2000 and 300 mg/kg bw by gavage. Animals were then observed for mortality, clinical signs and bodyweights and were all sacrificed for macroscopic examination.
No mortality was observed at dose 300 mg/kg bw and death was observed for the 3 rats treated at dose 2000 mg/kg.
No clinical signs related to the administration of the test item were observed at dose 300 mg/kg bw. Body weight gain of the treated animals was not affected by test item at dose 300 mg/kg bw.
Animals treated at 2000 mg/kg showed a reduction in spontaneous activity, muscle tone and righting reflex during the first hours of the treatment.
In this study, the oral LD50 of 6,6-DIMETHYL-2-CYCLOHEXENONE was considered to be 500 mg/kg bw in female rats.
Therefore, 6,6-DIMETHYL-2-CYCLOHEXENONE is lassified in category 4 (H302) according to CLP Regulation (EC) No 1272/2008.
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