Bisdecanoyl peroxide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2 july 1998 to 16 july 1998

Reliability:

1 (reliable without restriction)

Cross-reference

Reason / purpose for cross-reference:

reference to same 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)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bisdecanoyl peroxide

EC Number:

212-092-1

EC Name:

Bisdecanoyl peroxide

Cas Number:

762-12-9

Molecular formula:

C20H38O4

IUPAC Name:

decanoyl decaneperoxoate

Test material form:

solid: compact

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'Arbesle, France.
- Age at study initiation: approximately 8 weeks old.
- Weight at study initiation: mean body weight of 253 +/- 12 g for males, and 234 +/- 4 g for females.
- Housing: during the acclimatization periode, four to sevens animals of the same sex were housed in polycarbonate cages.
during the treatment period, the animals were housed individually in polycarbonate cages.
- Diet (e.g. ad libitum): free acces to A04 C pelleted diet.
- Water (e.g. ad libitum): was filtered by a FG Millipore membrane (0.22 micron) and provided ad libitum
- Acclimation period: 5 days before the study beginning

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C +/- 2°C
- Humidity (%): 30 to 70 %
- Air changes (per hr): 12 cycles/hour
- Photoperiod (hrs dark / hrs light): 12h/12h

IN-LIFE DATES: From: 2 july 1998 To: 16 july 1998

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

purified

Details on dermal exposure:

TEST SITE
- Area of exposure: for males : 5 cm x 6 cm; for females : 5 cm x 7 cm
- % coverage: approximately 10% (calculated by Meeh's formula)
- Type of wrap if used: hydrophilic gauze pad pre-moistened with 2 ml of water. It's held in contact by an adhesive hypoallergenic aerated semi-occlusive dressing and a restaining bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test substance was removed using a dry gauze pad

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg of animal body weight

Duration of exposure:

24 hours

Doses:

2000 mg/kg. To dose applied to each animal was ajusted according to body weight determined on the day of treatment.

No. of animals per sex per dose:

5 females/dose
5 males / dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: rats were observed frequently during the hours following administration of the test substance, for detection of possible treatment-related clinical signs. thereafter, observation of the animals was made at least once a day.
animals were weight individually just before administration of the test substance on day 1 and then on day 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: After death, macroscopic examination of the main organs (digestive tract, heart, kidney...)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

No deaths occured

Clinical signs:

other: No clinical signs

Gross pathology:

Necropsy after the death revealed no abnormalities.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under experimental conditions, the dermal LD0 of didecanoyl peroxide is higher than 2000 mg/kg in rats.

Executive summary:

The acute dermal toxicity of didecanoyl peroxide (purity: 99.1%) was evaluated in rats according to OECD N° 402 guideline and EC 92/69/EEC B.3 guidelines (Acute Toxic Standard Method). It was applied to the skin of groups of 5 males and 5 females Sprague Dawley rats at dose of 2000 mg/kg with a semi-occlusive dressing for 24 hours. Following treatment, rats were observed frequently following hours after treatment. Thereafter, they were observed daily. Rats were weighted the day of treatment (day 1), then days 8 and 15. A necropsy examination was performed at the time of scheduled euthanasia (Day 15).

No deaths occurred during the study. No clinical signs and no cutaneous reactions were observed. The body weight gain was lower for 1 female during the period of day 1 to day 8, and for another female during the period of day 8 to day 15. Necropsy after death reveals no abnormalities.

Under experimental conditions, the dermal LD0 of didecanoyl peroxide is equal to or higher than 2000 mg/kg in rats.