Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-2005
Reliability:
1 (reliable without restriction)

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:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
24th February 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
31st July 1992
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source/Breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 8 weeks old
- Weight at study initiation: 321 +/- 10 g for the males and 211 +/- 4 g for the females
- Fasting period before study: no data
- Housing: individually in polycarbonate cages with stainless steel lid (35.5 cm x 23.5 cm x 19.3 cm)
- Diet: free access to adapted pelleted diet
- Water: Drinking water filtered by a FG Millipore membrane (0.2 micron) was provided ad libitium.
- Acclimation period: at least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature: 22+/- 2 °C
- Humidity: 30 to 70 %
- Air changes: approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod: 12 h light/12 h dark

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 cm x 7 cm for males and 5 cm x 6 cm for the females
- Type of wrap if used: an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage

TEST MATERIAL
- Amount(s) applied: 2.41 mL/kg
- Constant volume or concentration used: yes

Duration of exposure:
single
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: The animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day 15. Type, time of onset and duration of clinical signs were recorded for each animal individually. From day 2, any local cutaneous reaction was recorded.
The animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study.
Clinical signs:
No clinical signs and no cutaneous reactions were observed during the study.
Body weight:
A slightly reduced body weight gain was seen in 2/5 females during the second week of the study.
Gross pathology:
Macroscopic examination of main organs of the animals revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD0 of the test item cyclohexylidenebis[tert-butyl] peroxide is higher than or equal to 2000 mg/kg in rats.
Executive summary:

The acute dermal toxicity of the test item cyclohexylidenebis[tert-butyl] peroxide was evaluated in rats according to OECD guideline No. 402 and EU method B.3. The test item was applied to the skin of one group of ten Sprague-Dawley rats (five males and five females).

The application was performed with diluted test item at the dose-level of 2000 mg/kg, taking into consideration that its specific gravity was 0.83 g/mL. The test site was then covered by a semi-occlusive dressing for 24 hours.

Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test item. All animals were subjected to necropsy.

No clinical signs, no cutaneous reactions and no deaths were observed during the study. A slightly reduced body weight gain was seen in 2/5 females during the second week of the study. The overall body weight gain of the other animals was similar to that of CIT historical control animals. No apparent abnormalities were observed at necropsy in any animal.

The dermal LD0 of the test item cyclohexylidenebis[tert-butyl] peroxide is higher than or equal to 2000 mg/kg in rats.