Bis(α,α-dimethylbenzyl) peroxide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study with full report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(α,α-dimethylbenzyl) peroxide

EC Number:

201-279-3

EC Name:

Bis(α,α-dimethylbenzyl) peroxide

Cas Number:

80-43-3

Molecular formula:

C18H22O2

IUPAC Name:

1,1'-(dioxydipropane-2,2-diyl)dibenzene

Details on test material:

- Identification : Perkadox BC FF
- Substance type: white crystalline powder
- Physical state: solid
- Analytical purity: 99.4%
- Lot/batch No.: 0419908022443
- Expiration date of the lot/batch: 04.10.2000

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 8 weeks
- Weight at study initiation: m= 314+/-26 g, f = 220+/- 12g
- Fasting period before study:
- Housing:
- Diet: pelleted laboratory animal diet (from Carfil Quality BVBA)
- Water: tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 30-70%
- Air changes (per hr): 15/h
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

corn oil

Details on dermal exposure:

TEST SITE
- Area of exposure: 25 cm2 for males and 18 cm2 for females
- % coverage: 10
- Type of wrap if used: dressing, consisted of surgical gauze patch, successively covered with aluminium foil and Coban flexible bandage (Micropore tape used additionally in females only)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: 24h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg (10 ml/kg)

Duration of exposure:

24h

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: mortality twice daily, body weights d1, d8 and d15, clinical signs daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs of systemic toxicity were noted in any of the animals.

Gross pathology:

No abnormalities were found at macroscopic pots mortem examination.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 value of the substance was found to be greater than 2000 mg/kg bw.

Executive summary:

In a study performed according to OECD 402, no deaths occurred in either sex of rats during the observation period at a limit dose of 2000 mg/kg. Abnormalities of general condition were not observed in any males or females during the observation period. Therefore, the LD50 is >2000 mg/kg.