Disodium Capryloyl Glutamate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From October 25, 1898 to November 08, 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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:

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

Test material form:

solid

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 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 d
- Frequency of observations and weighing: once a day; and body weights were recorded on Days 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

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A study was conducted to determine the acute oral toxicity of the substance according to OECD Guideline 401, in compliance with GLP. Male and female Sprague-Dawley rats were administered

Executive summary:

A study was conducted to determine the acute oral toxicity of the substance according to OECD Guideline 401, in compliance with GLP. Male and female Sprague-Dawley rats were administered the test substance by oral gavage at a dose of 2000 mg/kg bw. Following administration, the animals were observed for 14 d and mortality, clinical signs and body weights were recorded daily. At the end of this period, rats were examined for macroscopic and microscopic abnormalities. There was no mortality. No evidence of systemic toxicity was noted. No toxicologically significant effects on bodyweight were recorded during the study period and no abnormalities were seen at necropsy of animals killed at the end of the study. Under the study conditions, the acute oral LD50 of the substance in rats was determined to be >2000 mg/kg bw (Safepharm Laboratories Limited, 1989a).