Bisdecanoyl peroxide

Endpoint summary

Description of key information

Acute oral toxicity

In an acute oral toxicity test the substance was given by gavage as a 50 % (w/v) solution in Shellsol T to groups of 10 male and female Wistar rats (Til, 1979). There were very few details on the substance and no individual records. Nevertheless the study was sufficient for acute oral toxicity assessment. The animals received 10 ml per kg, therefore approximately 5000 mg/kg didecanoyl peroxide of body weight. Following treatment, rats were observed frequently following hours after treatment. Thereafter, they were observed daily. The rats were weighted the day of treatment after an overnight fasting. A necropsy examination was performed at the time of scheduled euthanasia (14 days after substance test administration). No deaths occurred during the study. But within a few hours after dosing the rats showed sluggishness, humpback behaviour, and sever diarrhoea. Signs of unthriftiness were observed throughout the first few post-treatment days. Then rats recovered gradually and looked quite healthy at the end of observation period. Moreover macroscopic examination of the survivor did not reveal any treatment-related gross alterations.The LD0 was > 5000 mg/kg.

Acute dermal toxicity

The acute dermal toxicity of didecanoyl peroxide (purity: 99.1 %) was evaluated in rats according to OECD N° 402 guideline (Manciaux, 1998). No deaths occurred during the study. No clinical signs and no cutaneous reactions were observed. The body weight gain was lower for one 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 revealed no abnormalities. The LD0 was > 2000 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 2e: study acceptable for assessment, but very few data, no Certificat of Analysis, no GLP compliant

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no CoA, not GLP, no individual data

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Institute's colony
- Age at study initiation: it is indicated "young"
- Weight at study initiation: for males, weight varied from 188 g to 230 g; for females, weight varied from 104 to 138 g
- Housing: in groups of five in screen-bottomed stainless steel cages
- Diet (e.g. ad libitum): stock diet
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: no submitted
- Fasting before dosing: yes, rats were fasted overnight before dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/-1°C
- Humidity (%): no submitted
- Air changes (per hr): no submitted (but it is indicated it was "well-ventilated"
- Photoperiod (hrs dark / hrs light): no submitted

IN-LIFE DATES: no submitted

Route of administration:

oral: gavage

Vehicle:

other: Shellsol T : isoparaffinic hydrocarbon solvent

Details on oral exposure:

VEHICLE : Shellsol T
- Concentration in vehicle: 50 %

Doses:

single dose of 5000 mg/ kg of body weight

No. of animals per sex per dose:

10 animals per sex and per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD0

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths occured

Clinical signs:

other: Few hours after dosing, the rats showed: - sluggishness - humpback behaviour - severe diarrhoea During the first few post-treatment days: - signs of unthriftiness Then later on the rats recovered gradually and look quite healthy at the end of the observ

Gross pathology:

Macroscopic examination of the survivors ( all rats) did not reveal any treatment related gross alterations.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under experimental conditions, the oralLD 0 of didecanoyl peroxid is higher than 5000 mg/kg in rats

Executive summary:

The acute oral toxicity of didecanoyl peroxide was tested in an acute oral toxicity test, similar to OECD n°401 guideline. The substance was given by gavage as a 50 %(w/v) solution in Shellsol T to groups of Wistar rats (10 males and 10 females). The animals received 10 ml per kg, therefore 5000 mg/kg didecanoyl peroxide of body weight.

Following treatment, rats were observed frequently following hours after treatment. Thereafter, they were observed daily. The rats were weighted the day of treatment after an overnight fasting. A necropsy examination was performed at the time of scheduled euthanasia (14 days after substance test administration)

No deaths occured during the study. But within a few hours after dosing the rats showed sluggishness, humpback behaviour, and sever diarrhoea. Signs of unthriftiness were observed throughout the first few post-treatment days. Then rats recovered gradually and looked quite healthy at the end of observation period. Moreover macroscopic examination of the survivor did not reveal any treatment-related gross alterations.

Under experimental conditions, the oral LD 0 of didecanoyl peroxide is higher than 5000 mg/kg in rats

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

Klimisch 2 study, not GLP compliant, with few data, but sufficient for assessment of acute oral toxicity.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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)

Reason / purpose for cross-reference:

reference to same study

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))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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

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...)

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.

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.

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

Klimisch 1 study, GLP compliant.

Justification for classification or non-classification

According to EU Regulation (EC) N0. 1272/2008 (CLP), the substance is not classified for acute toxicity.