Bis(α,α-dimethylbenzyl) peroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study design comparable to OECD Guideline 401. Study in Japanese with complete English translation.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

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 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

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:

Purity: 98.9%
Lot No.: 8X04
Supplier: Nippon Oil & Fats Co., Ltd

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River japan, Yokohama
- Age at study initiation: 6 weeks
- Weight at study initiation: m= 165-175g, f= 123-130g
- Fasting period before study: 3 hr
- Housing: 5 in a stainless steel wire mesh cage
- Diet (e.g. ad libitum): Pelleted diet, lot No: 980910, Oriental Yeats Co., Ltd
- Water (e.g. ad libitum): Tap water
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.3-24.4°C
- Humidity (%): 51-67%
- Air changes (per hr): 20 per hr
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: not given
- Amount of vehicle (if gavage): 0.5 mL per 100 g bw
- Justification for choice of vehicle: corn oil
- Lot/batch no. (if required): V5E1697

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days

Statistics:

Statistical analysis was not performed.

Results and discussion

Preliminary study:

no animals died in the preliminary study at 2000 mg/kg bw

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 animal died

Clinical signs:

other: Neither males nor females showed abnormal general conditions throughout the observation period.

Gross pathology:

No pathological lesions were observed in males or females in the necropsy at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 values were more than 2000 mg/kg for both sexes.

Executive summary:

In a study performed according to OECD 401, no deaths occurred in either sex of rats during the observation period. Abnormalities of general condition were not observed in any males or females during the observation period. Therefore, the LD50 is >2000 mg/kg.