N,N-dimethyl-3-oxobutyramide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

Litchfield and Wilcoxan method.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acetoacetdimethylamide

IUPAC Name:

Acetoacetdimethylamide

Test material form:

solid - liquid: suspension

Details on test material:

Test item name: Acetoacetdimethylamide

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Rats:
----
Female Wistar rats weighing 200 +- 20 g. These animals were housed in grid-floor cages under natural lighting conditions with the ambient temperature maintained at 22°C.
Mice:
----
Tylers original strain weighing 20 +- 2 g. These animals were housed in solid floor polycarbonate boxes under natural lighting conditions and maintained at 22°C.
Rabbits:
-------
New Zealand White does weighing 2.0 +- 0.2 kg. All animals were caged individually under natural lighting conditions maintained at 22°C.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water and 0.5% aqueous solution of Tween 80

Details on oral exposure:

Groups of animals were observed for a period of one week and the signs of toxicity and total deaths in each group noted.

Doses:

Range-finding:
--------------
solid material: 5000 mg/kg, 2500 mg/kg, 1000 mg/kg and 500 mg/kg
liquid samples: 5.0 mL/kg, 2.5 mL/kg, 1.0 mL/kg and 0.5 mL/kg
LD 50 Determination:
-------------------
Mouse: 5 mL/kg

No. of animals per sex per dose:

Range -finding:
--------------
Rats, Rabbits and Mice: Two animals per dose
LD 50 Mouse:
------------
Ten animals (5 male and 5 female mice)

Control animals:

no

Details on study design:

All animals were fasted overnight prior to administration and provided their normal food and water subsequent to dosing. All materials were administered by gavage using metal cannulae for mice and rats and a rubber stomach catheter for rabbits.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks:

suspended in 10% aqueous solution

Mortality:

No mortality observed.

Clinical signs:

other: No signs of toxicity or clinical signs observed.

Gross pathology:

No information available.

Other findings:

No other findings were detected.

Any other information on results incl. tables

Tylers Mice and New Zealand White Rabbits were also used in the LD50 investigation. No animals died during the observation period. No clinical signs were observed during the fourteen days.

Therefore, the LD50 of the test item for Mice is > 5 mL/kg bw at a dosing concentration of 10% aqueous solution and the LD50 for Rabbits is > 5 mL/kg bw (test item undiluted).

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No animals died during the observation period. No clinical signs were observed during the fourteen days.
Therefore, the LD50 of the test item is > 5000 mg/kg bw.

Executive summary:

The study was conducted prior to GLP and OECD guideline implementation.

Acceptable for reliability but not in detail documented. Nevertheless, the study report meets basic scientific principles.

This study was undertaken to determine the oral median lethal dose (LD50) of test article LZ705 in Wistar rats. The study was performed during August 1973.

No animals died during the observation period. No clinical signs were observed during the fourteen days.

Therefore, the LD50 of the test item is > 5000 mg/kg bw.