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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:
25 October 1989 to 8 November 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
Chemical structure
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
Molecular formula:
C17 H32 N1 O4 Na1
IUPAC Name:
l-Glutamic acid, N-coco acyl derivs., monosodium salts

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- 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: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 51 - 66%
- Air changes (per hr): 15 air changes per hour
- 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
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:
other: Not classified according to EU criteria
Conclusions:
Under the conditions of the study, the acute oral LD50 was determined to be in excess of 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 standardised guidelines OECD 401 and EU Method B.1, under GLP conditions.

During the study, 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.

Under the conditions of the study, 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 and 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 therefore concluded to be greater than 2000 mg/kg bw.