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Diss Factsheets

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:
2005
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

Constituent 1
Chemical structure
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
Constituent 2
Chemical structure
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
Constituent 3
Chemical structure
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
Constituent 4
Chemical structure
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
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:
There were no signs of systemic toxicity
Body weight:
All animals showed expected gains in bodyweight over the study period
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.