tert-butyl hydroperoxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: modified 40 CFR 163.81-1

Deviations:

yes

Remarks:

method equivalent to original EU B.1 LD50 method

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl hydroperoxide

EC Number:

200-915-7

EC Name:

tert-butyl hydroperoxide

Cas Number:

75-91-2

Molecular formula:

C4H10O2

IUPAC Name:

2-methylpropane-2-peroxol

Details on test material:

Aqueous solution containing ca 70 wt% TBHP
TBHP content 70%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Marland Farms, Hewitt, New Jersey
- Weight at study initiation: 113-163 g
- Fasting period before study: night before study
- Housing: 5 per sex per cage
- Diet (e.g. ad libitum): wayne lab blox
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 19 days

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Oral gavage assumed

Doses:

0.6, 0.8, 1.0, 1.2, 1.4, 1.6 ml/kg

No. of animals per sex per dose:

10 animals per dose (5 male; 5 female)

Control animals:

no

Details on study design:

Following dosing, the behaviour of the animals were observed frequently for the first day and then four times daily for a period of 14 days. All dead animals were necropsied and survivors were killed with CO2 and necropsied at the end of 15 days.

Statistics:

The LD50 was calculated using the method of Litchfield and Wilcoxon.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 560 mg/kg bw

95% CL:

>= 476 - <= 658

Mortality:

1/10 rats dosed with 0.6 mL/kg, 5/10 rats dosed with 0.8 mL/kg, 7/10 rats dosed with 1.0 mL/kg and 10/10 rats dosed with 1.2, 1.4 and 1.6 mL/kg died during the test period.

Clinical signs:

other: Depression, pallor, loss of righting, lacrimation, hypothermia and haematuria were observed.

Gross pathology:

Gastric erosions, blood in the GI tract, haematuria. Greyish tan lungs, stomach, duodenums, pancreas and adrenals. Pale kidneys and pancreas were observed at most dose levels.

Any other information on results incl. tables

The LD50 value is reported in terms of both test material (aqueous solution) and TBHP itself (present at 70 wt%): for dry TBHP, an LD50 value of 560 mg/kg was determined.

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Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

It is concluded that TBHP in test material is moderately toxic to rats via exposure through the oral route, with an acute LD50 value of 560 mg/kg.

Executive summary:

The study shows that TBHP is moderately toxic to rats when given via the oral route, with an acute LD50 value of 560 mg/kg. The results presented here corresponds to a classification of acute oral toxicity category 4 under Regulation 1272/2008, CLP GHS.