tert-butyl 3,5,5-trimethylperoxyhexanoate

Acute Toxicity: dermal

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)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl 3,5,5-trimethylperoxyhexanoate

EC Number:

236-050-7

EC Name:

tert-butyl 3,5,5-trimethylperoxyhexanoate

Cas Number:

13122-18-4

Molecular formula:

C13H26O3

IUPAC Name:

tert-butyl 3,5,5-trimethylhexaneperoxoate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system 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: All the animals had free access to A04 C pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France).
- Water: 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: 21 ± 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: 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

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No death occurred during the study

Clinical signs:

other: No clinical signs and no cutaneous reactions were observed during the study.

Gross pathology:

Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

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.