Amides, C8-10, N-(hydroxyethyl)

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:

supporting study

Study period:

November 1992 - March 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline compliant study and generally conducted according to GLP principles

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

not specified

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Remarks:

-"OECD Principles of Good Laboratory Practice" (Decision C(81)30 Final), 12 May1981. -"Bonnes Pratiques de Laboratoire" described in the French "Instruction du Ministere des Affaires Sociales et delal Solidarité Nationale" 31 May 1983.

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

35627-69-4

IUPAC Name:

35627-69-4

Test material form:

other: liquid

Details on test material:

amide of fatty acid (C18-branched) and alkanolamine ( 2-hydroxypropylamine): isostearic acid monoisopropanolamide.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

No information

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test material was administered as supplied.

Doses:

preliminary study: 506, 1003 and 2006 mg/kg bw
main study: 2006 mg/kg bw

No. of animals per sex per dose:

preliminary study: 2.
main study: 5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Animals were observed for clinical signs at 15 min, 1, 2 and 4 h after administration and daily thereafter for 14 d. Animals were weighed one day prior to dosing, on the day of dosing, on Days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic observations of the organs were performed following necropsy on Day 15.

Statistics:

No information

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 006 mg/kg bw

Mortality:

No moratlity observed

Clinical signs:

other: No treatment related clinical signs observed

Gross pathology:

No treatment related macroscopic necropsy findings observed

Other findings:

None

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 acute oral LD50 of the test material was found to be > 2006 mg/kg bw in Sprague Dawley rats

Executive summary:

A limit test was conducted to determine the acute oral toxicity of the test material in Sprague Dawley rats.

The test material was administered, as supplied, through oral gavage as a single dose of 2006 mg/kg bw to 5 male and 5 female rats. Thereafter the rats were observed for mortality, clinical signs and change in body weight for 14 d. On day 15, the animals were necropsied and the macroscopic observation of the organs were carried out.

All animals survived tiil the end of observation period.There were no treatment related changes in body weights, clinical signs and gross pathology.

Hence, under the test conditions, the acute oral LD50 of the test material was found to be > 2,006 mg/kg bw in Sprague Dawley rats.