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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

Constituent 1
Chemical structure
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 peracetate

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: e.g. 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 levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
2 130 mg/kg bw
Based on:
test mat.
95% CL:
1 698 - 2 671
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
3 083 mg/kg bw
Based on:
test mat.
95% CL:
2 458 - 3 866
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:
see any other information on results
Clinical signs:
not described
Body weight:
The body weight gain was reduced in one female between day 7 and 14.
Gross pathology:
not investigated
Other findings:
no

Any other information on results incl. tables

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).