[No public or meaningful name is available]

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:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Principles of method if other than guideline:

Groups of 6 males were administered 0, 5000, 10000 and 20000 mg/kg bw of the test substance by stomach intubation. The animals were observed for 14 d.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of C14-C18 (even numbered) and C14-C18-unsatd. (even numbered) fatty acids or triglycerides with diethanolamine

Molecular formula:

not applicable gor UVCB

IUPAC Name:

Reaction products of C14-C18 (even numbered) and C14-C18-unsatd. (even numbered) fatty acids or triglycerides with diethanolamine

Test material form:

liquid: viscous

Details on test material:

see Section 1.2 for detailed composition

Reference

Constituent 1

Reference substance name:

Amides, C18-unsatd., N,N-bis(hydroxyethyl)

EC Number:

700-972-2

Molecular formula:

C22H43NO3

IUPAC Name:

Amides, C18-unsatd., N,N-bis(hydroxyethyl)

Details on test material:

- Name of test material (as cited in study report): Varamide A-7

Specific details on test material used for the study:

The discrepancy between originally usded identifier of the substance and new test material information is due to change in the main identifier through the Substance identity adaptation service offered by ECHA. The new identifier is covered by old identifier mentioned in Additional test material information section

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: male: 150-250 g
- Fasting period before study: 24 h
- Housing: Screen bottom cages
- Diet (e.g. ad libitum): Laboratory chow (ad libitum)
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

Six adult SD rats per dose group were given the test substance by stomach intubation.

Doses:

0, 5,000, 10,000 and 20,000 mg/kg.

No. of animals per sex per dose:

Males: 6/dose/group

Control animals:

not specified

Details on study design:

Male SD rats were fasted for 24 h and then administered single doses of the test substance by stomach intubation followed by 14 d of observation period.

Statistics:

No data

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

10 000 mg/kg bw

Based on:

test mat.

Mortality:

Number of dead/number dosed:
- No mortality occured at lowest dose of 5,000 mg/kg, i.e., 0/6
- 50% mortality was observed In the mid dose group of 10,000 mg/kg, i.e., 3/6
- Almost all animals died in the highest dose group of 20,000 mg/kg, i.e., 5/6.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of the test substance in SD rats was found to be 10000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance in Sprague Dawley rats. Groups of 6 males were administered 0, 5000, 10000 and 20000 mg/kg bw by stomach intubation and observed for 14 d. Approximately 50% mortality occurred at the mid dose. Under the study conditions, the oral LD50 was therefore 10000 mg/kg bw (Casey, 1976).