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EC number: 943-328-8 | CAS number: -
- Life Cycle description
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 11 to 25, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: GLP study comparable to OECD TG 401.
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:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Section 1500.3 - Federal Hazardous Substances Act Regulations - 16 CFR
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- environmental conditions not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction Mass of 4-(2,6,6-trimethylcyclohex-1-en-1-yl)butan-2-one and 4-(2,6,6-trimethylcyclohex-2-en-1-yl)butan-2-one and 4-[(1RS,6RS)-2,2,6-trimethylcyclohexyl]butan-2-one and (2RS,4aRS)-2,5,5-trimethyl-1,2,3,4,4a,5,6,7-octahydronaphthalen-2-ol and 2,5,5-trimethyl-1,2,3,4,5,6,7,8-octahydronaphthalen-2-ol
- EC Number:
- 943-328-8
- Molecular formula:
- Not applicable
- IUPAC Name:
- Reaction Mass of 4-(2,6,6-trimethylcyclohex-1-en-1-yl)butan-2-one and 4-(2,6,6-trimethylcyclohex-2-en-1-yl)butan-2-one and 4-[(1RS,6RS)-2,2,6-trimethylcyclohexyl]butan-2-one and (2RS,4aRS)-2,5,5-trimethyl-1,2,3,4,4a,5,6,7-octahydronaphthalen-2-ol and 2,5,5-trimethyl-1,2,3,4,5,6,7,8-octahydronaphthalen-2-ol
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): MT-112
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sherman-Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200-300 g
- Fasting period before study: Animals were fasted overnight before dosing.
- Diet: Food, ad libitum
- Water: Water, ad libitum
IN-LIFE DATES: From: February 11, 1981 To: February 25, 1981.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- No data
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing:
Animals were observed for mortality and clinical signs daily for 14 days. Initial and final bodyweights of animals were recorded.
- Necropsy of survivors performed: Yes; animals were subjected to gross necropsy. - Statistics:
- None
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 2/5 males and 1/5 female were died within 24 h of dosing.
- Mortality:
- - 2/5 males and 1/5 females were died within 24 h of dosing.
- Clinical signs:
- other: other: - Animals were depressed, ruffled and dirty within 3-4 h of dosing. - After 5-6 h several animals were severely depressed or semicomatose. - Surviving animals remained in generally poor health for 4-5 days before recovering.
- Gross pathology:
- - No abnormalities were noted at necropsy.
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Oral LD50 Combined > 5000 mg/kg bw
- Executive summary:
In an acute oral toxicity study (limit test), performed similarly to OECD Guideline No. 401, a group of Sherman-Wistar rats (5/sex) were administered a single oral dose of test material at 5000 mg/kg bw by gavage. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.
2/5 males and 1/5 females were died within 24 h of dosing. Animals were depressed, ruffled, dirty within 3 -4 h of dosing and severely depressed or semicomatose after 5-6 h of dosing. Surviving animals remained in generally poor health for 4-5 days before recovering. All animals showed expected gains in bodyweight over the 14 -day study period. No abnormalities were noted at necropsy
Oral LD50 Combined > 5000 mg/kg bw
Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP).
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
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