tert-butyl peracetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978-08-23 and 1978-12-15

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

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:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl peracetate

EC Number:

203-514-5

EC Name:

tert-butyl peracetate

Cas Number:

107-71-1

Molecular formula:

C6H12O3

IUPAC Name:

tert-butyl ethaneperoxoate

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: 222 to 300 g
- Fasting period before study: for an overnight period of approximately 18 hours immediately preceding oral administration during which food, but not water, was withheld
- Housing: housed by sex, in groups of five rats per cage, in hanging wire-mesh cages in temperature and humidity controlled quarters.
- Diet and water: ad libitum
- Acclimation period: 27 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

All the dosage levels were administered at a volume of 10 mL/kg.

Doses:

807.1, 1281, 2034, 3229 and 5126 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: Mortality was observed, only, during the first 4 hours following dosing and twice daily thereafter for a total of 14 days.
- Frequency of weighing: Body weights were recorded immediately prior to dosing (control weight) and at 7 and 14 days.

Statistics:

95% confidence limits

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

2 130 mg/kg bw

Based on:

test mat.

95% CL:

1 698 - 2 671

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

3 083 mg/kg bw

Based on:

test mat.

95% CL:

2 458 - 3 866

Effect levels 3

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 562 mg/kg bw

Based on:

test mat.

95% CL:

2 153 - 3 050

Mortality:

please refer to Table 1 ("Any other information on results incl. tables")

Clinical signs:

other: not described

Gross pathology:

not investigated

Other findings:

no

Any other information on results incl. tables

Table 1: Summary of mortality

Time of Observation	Number of Deaths
	Dosage Level (mg/ kg)
	807.1		1281		2034		3229		5126
	M	F	M	F	M	F	M	F	M	F
0 – 4 hours									2	2
Day 1					1		4	2	3	3
Day 2					1			1
Day 3							1
Day 4 -14
Total	0/5	0/5	0/5	0/5	2/5	0/5	5/5	3/5	5/5	5/5

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

Based upon the data obtained, the acute oral LD50 values and 95% confidence limits for the test material (75% act. ingr.) were calculated to be as follows: Male Rats: 2130 (1698 - 2671) mg/kg bw, Female Rats: 3083 (2458 - 3866) mg/kg bw, Combined Male and Female Rats: 2562 (2153 - 3050) mg/kg bw. For a mixture containing 50% active ingredient the acute oral LD50 values are expected to be 3195 mg/kg bw (males), 4624.5 mg/kg bw (females) and 3843 mg/kg bw (combined males and females).

Executive summary:

An acute oral toxicity study was performed in 25 male and 25 female rats of the Sprague-Dawley strain, obtained from Harlan Industries. The test material, 75% TBPA in Shellsol 71, was administered orally by gavage as a solution in corn oil at the following dosage levels: 807.1, 1281, 2034, 3229 and 5126 mg/kg bw. Five rats of each sex were used at each dosage level. Water and diet were available ad libitum, except for an overnight period of approximately 18 hours immediately preceding oral administration during which food, but not water, was withheld. The rats were observed for mortality, only, during the first 4 hours following dosing and twice daily thereafter for a total of 14 days. Mortality was observed within 3 days at the dosage levels of 2034, 3229 and 5126 mg/kg bw. The acute oral LD50 values are 2130 mg/kg bw (males), 3083 mg/kg bw (females) and 2562 mg/kg bw (combined males and females). For a mixture containing 50% active ingredient the acute oral LD50 values are calculated to be 3195 mg/kg bw (males), 4624.5 mg/kg bw (females) and 3843 mg/kg bw (combined males and females).