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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:
other: early study report, scientifically acceptable, equivalent or similar to OECD TG 201

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

Constituent 1
Chemical structure
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
Test material form:
other: clear 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
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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.