N,N'-(2-chloro-5-methyl-1,4-phenylene)bis[3-oxobutyramide]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975-09-01

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable for reliability but not in detail documented. Study report meets basic scientific principles. Study was conducted prior to GLP and OECD guideline implementation.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

The results were calculated to the method of Litchfield, J.T. and Wilcoxon, F. (1949) J. Pharm Exp Therap. 96

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-(2-chloro-5-methyl-1,4-phenylene)bis[3-oxobutyramide]

EC Number:

255-235-3

EC Name:

N,N'-(2-chloro-5-methyl-1,4-phenylene)bis[3-oxobutyramide]

Cas Number:

41131-65-1

Molecular formula:

C15H17ClN2O4

IUPAC Name:

N-[5-chloro-2-methyl-4-(3-oxobutanamido)phenyl]-3-oxobutanamide

Details on test material:

The test material was diluted or suspended as necessary in a suitable dose vehicle.
Vehicle: 0.5% Aqueous Tween 80

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5% aqueous Tween 80

Doses:

500 mg/kg
1000 mg/kg
2500 mg/kg
5000 mg/kg

No. of animals per sex per dose:

5 male and 5 female were used for each dose level.

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

There were no signs of toxicity, deaths and incidence of mortality recorded neither in the preliminary range-finding trial nor in the final assay.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

LD50 value of DiAAclomam is > 5000 mg/kg, therefore the test item is not classified.

Executive summary:

The study was performed 1975, following the method of Litchfield, J.T. and Wilcoxon, F. (1949) J. Pharm Exp Therap. 96 , before GLP- and OECD-testing guidelines were available and in force.

In the preliminary range-finding trial and in the final assay no signs of toxicity were recorded. The LD50 of substance DiAAclomam is > 5000 mg/kg and therefore is not classified according to GHS classification criteria.