tert-butyl peroxypivalate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD TG 201

Principles of method if other than guideline:

5 doses were applied orally by gavage to rats, which were observed the following 14 days.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl peroxypivalate

EC Number:

213-147-2

EC Name:

tert-butyl peroxypivalate

Cas Number:

927-07-1

Molecular formula:

C9H18O3

IUPAC Name:

tert-butyl 2,2-dimethylpropaneperoxoate

additive 1

Reference substance name:

2,2,4,6,6-pentamethylheptane

EC Number:

236-757-0

EC Name:

2,2,4,6,6-pentamethylheptane

Cas Number:

13475-82-6

Molecular formula:

C12H26

IUPAC Name:

isododecane

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Industries, Inc. Indianapolis; Indiana
- Weight at study initiation: 200 to 248 g
- Fasting period before study: overnight period before administration of test item
- Housing: 5 rats per sex per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 8 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Amount of vehicle: 10 mL to 20 mL

MAXIMUM DOSE VOLUME APPLIED: 20 mL

Doses:

1585; 2512; 3980; 6308 and 10000 mg/kg bw

No. of animals per sex per dose:

5 per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: during the first 4 hours, at 24 h and daily for a total of 14 days
- Frequency of weighing: prior to dosing and on day 7 and 14
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 169 mg/kg bw

Based on:

test mat.

95% CL:

> 3 587 - < 4 845

Mortality:

1585 mg/kg bw : 0/10
2512 mg/kg bw: 0/10
3980 mg/kg bw: 4/10
6308 mg/kg bw: 10/10
10000 mg/kg bw: 10/10

Clinical signs:

other: no data

Gross pathology:

no data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicits study with TBPPI in rats a combinded LD50 value of 4169 mg/kg bw was determined.

Executive summary:

Twenty-five male and twenty- five female rats of the Sprague Dawley strain were used for an acute oral toxicity study. The test material was administered orally by gavage as a solution in corn oil at the following dosage levels to male and female rats: 1585; 2512; 3980 and 10000 mg/kg bw. Five rats of each sex were used at each dosage level. All the dosage levels were administered at a volume of 10 mL/ kg except for the high dose, which was administed at a volume of 20 mL/kg.

The rats were observed for mortality, only, during the first four hours following dosing, at 24 hours and daily thereafter for a total of 14 days. Body weights were recorded immediately prior to dosing and at 7 and 14 days.

No animal died at the two lowest dosage levels. Four females died at the dosage level of 3980 mg/kg bw and all animals died in the two highest dosage levels.

The combined male and female acute oral LD50 value was 4169 mg/kg bw and the 95th confidence interval was 3587 - 4845 mg/kg bw.