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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998-06-24 to 1998-07-08
Reliability:
1 (reliable without restriction)
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
1992
Deviations:
no
Principles of method if other than guideline:
NA
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): PEROXY-3, 5, 5-TRIMETHYL HEXANOATE DE t-BUTYLE
- Physical state: colourless liquid
- Analytical purity: 99%
- Lot/batch No.: 620-9802-716
- CAS No.: 13122-18-4

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa Crédo, 69210 L'Arbresle, France
- Age and Weight at study initiation: On the day of treatment, the animals were approximately 8 weeks old, and had a mean body weight ± standard deviation of 255 ± 3 g for the males and 222 ± 11 g for the females.
- Fasting period before study:
- Housing: During the acclimatization period, four to seven animals of the same sex were housed in polycarbonate cages (48 cm x 27 cm x 20 cm). During the treatment period, the animals were housed individually in polycarbonate cages (35.5 cm x 23.5 cm x 19.3 cm)
- Diet (e.g. ad libitum): All the animals had free access to A04 C pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France).
- Water (e.g. ad libitum): Drinking water filtered by FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimatization: at least 5 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2°C
- Humidity (%): 30 to 70 %
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 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: females: 5 cm x 6 cm; males: 5 cm x 7 cm
- % coverage: approximately 10 %
- Type of wrap if used: A hydrophilic gauze pad was applied to the skin. The test substance and the gauze pad were held in contact with the skin for 24 hours by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At least once a day until day 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Not performed

Results and discussion

Preliminary study:
NA
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No death occurred during the study
Clinical signs:
No clinical signs and no cutaneous reactions were observed during the study.
Body weight:
The body weight gain of one female was reduced between day 1 and 15 and another female lost weight during this sample period. The overall body weight gain of the other animals was not affected by treatment with the test substance.
Gross pathology:
Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
Other findings:
NA

Any other information on results incl. tables

No remarks

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions, the dermal LD0 of the test substance tert-Butylperoxy-3,5,5-trimethylhexanoat is equal to or higher than 2000 mg/kg in rats.
Executive summary:

Tert-Butylperoxy-3,5,5-trimethylhexanoat was tested in a single dermal application to rats. The application was performed with the undiluted test substance at the dose of 2000 mg/kg, taking into consideration that its specific gravity was 0.89. 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 substance. All animals were subjected to necropsy.

No death occurred at 2000 mg/kg. No clinical signs were observed. The body weight gain of one female was reduced between day 1 and 15 and another female lost weight during this same period. The overall body gain of the other animals was not affected by treatment with the test substance. No cutaneous reactions were observed. No apparent abnormalities were observed at necropsy.

Under these experimental conditions, the dermal LD0 of the test substance tert-Butylperoxy-3,5,5-trimethylhexanoat is equal to or higher than 2000 mg/kg in rats.