Registration Dossier
Registration Dossier
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EC number: 212-855-9 | CAS number: 873-94-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-10-23 to 1995-11-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3,3,5-trimethylcyclohexan-1-one
- EC Number:
- 212-855-9
- EC Name:
- 3,3,5-trimethylcyclohexan-1-one
- Cas Number:
- 873-94-9
- Molecular formula:
- C9H16O
- IUPAC Name:
- 3,3,5-trimethylcyclohexan-1-one
- Details on test material:
- 3,3,5-trimethylcyclohexanone of Hüls AG, purity 98.7 % (GC-FID area), produced April 1995, ID No. 0637/81 736, internal No. 0166
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Strain: Hsd/Win:WU (SPF)
- Source: Harlan Winkelmann GmbH, Borchen (Germany)
- Weight at study initiation: males 255-290 g, females 219-253 g
- Controls: no-
- Diet: ad libitum, R10 special diet for rats, SSniff R
- Water: ad libitum, tab water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark
- Air changes (per hr): 15 per hour
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- ADMINISTRATION:
- Area covered: dorsolumbar region, approximately 10 % of the body surface, shaved 24 hours in advance
- Total volume applied: 2.25 ml/kg bw
- Occlusion: semiocclusive gauze dressing
- Removal of test substance: after 24 hours with corn oil and cellulose - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- EXAMINATIONS:
- Mortality, clinical signs: 30 minutes, 1, 2, 3, 4, 5, 6 hours after dosing, once daily for next 2 weeks
- Dermal response: Daily after patch removal
- Body weights: days 0 (prior to dosing), 7, and 14
- Macroscopic examination: day 14 - Statistics:
- not reliable
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- MORTALITY: No deaths
- Clinical signs:
- other: CLINICAL SIGNS - No signs of intoxication were observed throughout the observation period. SKIN REACTION: - at patch removal: erythema and edema (1 male), edema (1 male) - 48 hours after treatment: erythema (1 male, 1 female) - later / other 7 anima
- Gross pathology:
- NECROPSY FINDINGS: No indications of treatment related macroscopic organ changes were observed, particularly in skin and subcutaneous tissue.
- Other findings:
- no other findings
Any other information on results incl. tables
no further remarks
Applicant's summary and conclusion
- Conclusions:
- According to this study the LD50 value (dermall) was determined to > 2000 mg/kg bw in rats for the test item 3,3,5-trimethylcyclohexanone
- Executive summary:
The test item 3,3,5-trimethylcyclohexanone was applied to the dorsolumbar region (shaved 24 hours in advance) in a dose of 2000 mg/kg bw undiluted to 5 male and 5 female Wistar rats. The area was covered for 24 hours, afterwards the test item was removed with corn oil. one male and one female showed erythema and edema after patch removal, one male showed erythema 48 hours after treatment. Later there were no signs of irritation.No signs of intoxication were observed throughout the observation period and no indications of treatment related macroscopic organ changes were observed, particularly in skin and subcutaneous tissue. According to this study the LD50 value (dermall) was determined to > 2000 mg/kg bw in rats for the test item 3,3,5-trimethylcyclohexanone
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