Rape oil, reaction products with diethanolamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted on the structural analogue amides, C18(unsatd.), N,N-bis(hydroxyethyl) according to standard scientific principles.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

In the acute oral toxicity study, groups of adult SD rats were given the single calculated dose by stomach intubation and placed in screen bottom cages for a two week observation period and determination of lethal dose.

GLP compliance:

not specified

Test type:

other: No data provided

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N-bis(2-hydroxyethyl)oleamide

EC Number:

202-281-7

EC Name:

N,N-bis(2-hydroxyethyl)oleamide

Cas Number:

93-83-4

Molecular formula:

C22H43NO3

IUPAC Name:

N,N-bis(2-hydroxyethyl)octadec-9-enamide

Constituent 2

Reference substance name:

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

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

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:

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

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.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 of the test substance in SD rats was found to be 10,000 mg/kg bw. Hence, it can be considered to be not classified as per EU CLP classification system.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance amides, C18 -unsatd., N,N-bis(hydroxyethyl) in SD rats. Under the study conditions, the oral LD50 was determined to be 10,000 mg/kg bw and does not meet the requirement for classification according to according to EC criteria (67/548/EEC) and according to CLP criteria (EC 1272/2008).