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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From October 25, 1989 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

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:
No evidence of systemic toxicity was noted during the study period.
Body weight:
No toxicologically significant effects in bodyweight were 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:
Under the study conditions, the acute oral LD50 of the substance in rats was determined to be >2000 mg/kg bw.
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).