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EC number: 456-350-3 | CAS number: 878665-13-5
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 06 October 2005 to 20 October 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD test guideline No. 402 and in compliance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Compliance Programme (inspected on 2002-12-02)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- (3S)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
- Molecular formula:
- C25 H46 O S
- IUPAC Name:
- (3S)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
- Reference substance name:
- (3R)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
- Molecular formula:
- C25 H46 O S
- IUPAC Name:
- (3R)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
- Reference substance name:
- (3S)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
- Molecular formula:
- C25 H46 O S
- IUPAC Name:
- (3S)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
- Reference substance name:
- (3R)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
- Molecular formula:
- C25 H46 O S
- IUPAC Name:
- (3R)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
- Test material form:
- liquid
- Details on test material:
- - Physical state: colourless to pale yellow slightly viscous liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Specific details on test material used for the study:
- - Storage condition of test material: Room temperature in the dark under nitrogen
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8-12 weeks of age, female were nulliparous and non-pregnant
- Weight at study initiation: at least 200g
- Fasting period before study: not required
- Housing: solid-floor polypropylene cages furnished with woodflakes (individually housed during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study)
- Diet (e.g. ad libitum): ad libitum (Certified Rat and Mouse Diet, routinely analysed)
- Water (e.g. ad libitum): ad libitum, routinely analysed
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12:12
IN-LIFE DATES: From: 11 June 2008 To: 03 June 2008
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: 10 %
- Type of wrap if used: surgical gauze semi-occluded with a piece of self adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with cotton wool moistened with distilled water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.19 mL/kg bw
- Concentration (if solution): 0.915 mg/mL
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations (clinical sign and dermal irritation): 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
- Frequency of weighing: day 0, 7 & 14.
- Necropsy of survivors performed: yes - Statistics:
- None (limit test at one dose level of at least 2000 mg/kg bw)
Results and discussion
- Preliminary study:
- not applicable
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no death
- Clinical signs:
- other: There were no signs of systemic toxicity
- Gross pathology:
- No abnormalities were noted
- Other findings:
- There were no sign of dermal irritations
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. Under the test conditions, the test material does not meet the criteria for classification according to the Regulation EC No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In a limit acute dermal toxicity study performed according to the OECD guideline No. 402 and in compliance with GLP, groups of young adult Sprague-Dawley rats (5/sex) were semi-occlusively exposed to undiluted test material for 24 hours at dose of 2000 mg/kg bw. The animals were observed for mortality, clinical signs including dermal reactions and body weight for 14 days and then necropsied for macroscopic observations.
There were no death, no signs of systemic toxicity and no signs of dermal irritation. All animals showed expected bodyweight gains during the study. No abnormalities were noted at necropsy.
Dermal LD50 Combined > 2000 mg/kg bw
Under the test conditions, the test material does not meet the criteria for classification according to the Regulation EC No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.
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