Reaction mass of sodium hydrogen N-(1-oxooctadecyl)-L-glutamate and stearic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989/10/25 - 1989/11/08

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The registered substance is a UVCB material which contains substances of varying chain length. Read across was performed to an analogous material whose carbon chain length differs by an average of two CH2-groups from the registered substance. Because of the UVCB nature of these substances, the components of the registered substance were also present in the test material, albeit at slightly different concentration levels.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

L-Glutamic acid, N-coco acyl derivs., monosodium salts

EC Number:

269-087-2

EC Name:

L-Glutamic acid, N-coco acyl derivs., monosodium salts

Cas Number:

68187-32-6

IUPAC Name:

68187-32-6

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin & Kingman Ltd., Grimston, Aldborough, Hull, U.K.
- Age at study initiation: 5-8 weeks
- Weight at study initiation: male: 120-145g; female: 120-137g
- Fasting period before study: overnight immediately before dosing and for approximately two hours after dosing
- Housing: in groups of 5 by sex in polypropylene cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 51-66
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.94 mL/kg bw

Doses:

single dose of 2000 mg/kg bw

No. of animals per sex per dose:

10 (5 males and 5 females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once a day; bw were recorded on day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights, histopathology

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality occured.

Clinical signs:

other: No evidence of systemic toxicity was noted during the study period.

Gross pathology:

No abnormalities were noted at necropsy of animals killed at the end of the study.

Any other information on results incl. tables

Conclusion

The acute oral median lethal dose (LD50) of the test material, HOE S 3580-2, in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bw.

Executive summary

A study was performed to determine the acute oral median lethal dose (LD50) of the test material, administered undiluted, in the Sprague-Dawley strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 401 "Acute Oral Toxicity" referenced as Method B.1 in Annex V of EEC Commission Directive 84/449/EEC. A group of ten fasted Sprague-Dawley Rats (five males and five females) was given a single oral dose of undiluted test material at a dose level of 2000 mg/kg bodyweight. There were no deaths. No evidence of systemic toxicity was noted during the study period. No toxicologically significant effects on bodyweight were noted during the study period. No abnormalities were noted at necropsy of animals killed at the end of the study. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat, was found to be greater than 2000 mg/kg body-weight.

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

The test substance has not to be labelled with regard to oral toxicity.

Executive summary:

The test substance has been investigated for its oral toxicity in accordance with OECD guideline 401 under GLP conditions in male and female rats. All animals survived the treatment at the limit dose of 2000 mg/kg bw with no signs of toxicosis. The test substance has not to be labelled with regard to oral toxicity.