tert-butyl 3-oxobutanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-01-17 - 1985-02-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted according to OECD guideline and GLP.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Principles of method if other than guideline:

No further information available.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acetessigsäure-tert.butylester

IUPAC Name:

Acetessigsäure-tert.butylester

Constituent 2

Reference substance name:

t-Butyl-acetoacetate

IUPAC Name:

t-Butyl-acetoacetate

Test material form:

other: liquid

Details on test material:

Product no.: IMAH 005
Appearance: liquid, clear
Storage: at 22°C, under the hood, in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Oleum Sesami Ph. Eur. III

Doses:

2000 mg/kg
3150 mg/kg
5000 mg/kg
6.2 mg/kg
7.2 mg/kg

No. of animals per sex per dose:

5 female were used for each dose level.
5 male for dose level 3150 mg/kg and 5 male for dose level 5000 mg/kg were used.

Control animals:

no

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

4 480 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

Clinical symptoms were seen for all male and female rats after application of the test substance: Unsteady locomotion, unkempt coats, abnormal breathing, prone position and a general loss of activity. Mortality was noted at dosis 3150 mg/kg bw and at dosis 5000 mg/kg bw for male and female rats.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The calculated LD50 value of tert-Butyl acetoacetate is >5000 mg/kg/bw for male rats and for female rats 4480 mg/kg bw. Therefore, the test item will be not classified as acute toxic according to GHS/CLP classification criteria.

Executive summary:

The study was performed 1985, according to GLP- and OECD-testing guideline. The calculated LD50 value of tert-Butyl acetoacetate is >5000 mg/kg/bw for male rats and for female rats 4480 mg/kg bw. Therefore, the test item will be not classified as acute toxic according to GHS/CLP classification criteria.