Butanoic acid, 3-oxo-, 1,1'-[2-[(1,3-dioxobutoxy)methyl]-2-ethyl-1,3-propanediyl] ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

422-630-9

EC Name:

-

Cas Number:

22208-25-9

Molecular formula:

C18H26O9

IUPAC Name:

2,2-bis({[(3-oxobutanoyl)oxy]methyl})butyl 3-oxobutanoate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:(WI) BR

Sex:

male/female

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

other: No vehicle was used. The test substance was dosed undiluted.

Doses:

2000 mg/kg bw

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

not specified

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

salivation

Body weight:

other body weight observations

Remarks:

The body weight gain of the animals over the study period was considered to be similar to that expected of normal animals of the same age and strain.

Gross pathology:

Macroscopic post mortem examination of the animals at termination did not reveal any abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 in rats was higher 2000 mg/kg bw.

Executive summary:

The study was conducted according to EU Method B.1 and OECD 401 (GLP study). Albino wistar male and female rats were exposed orally to 2000 mg/kg bw test substance (limit test). Not significant clinical signs neither organ effects were observed. Thus, the oral LD50 was determined to be higher than 2000 mg/kg bw.