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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
A read-across study with an analogous substance was scientifically justified, because the target substance is the major component, and the central member of an homologous series of components, of the source substances, possessing identical functional groups and extremely similar structures. It is reasonable to expect that the toxicological properties of the target and source substances will not be markedly different. On this basis, experimental data on the source substances are expected to be directly applicable to the target substance, and can be used to adequately predict its properties. Further details are provided in an attached document to the repeated dose toxicity endpoint summary.

Data source

Reference
Reference Type:
publication
Title:
Toxicological properties of N-lauryl-L-glutaminic acids - surface active substances in the food industry
Author:
Zaitsev et al.
Year:
1984
Bibliographic source:
(1984), Vopr. Pitan. (4), p. 58-60

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
Principles of method if other than guideline:
112 treatment days. Relative organ weights investigated: liver, kidneys, spleen, adrenals, testes. Biochemical parameters: Hb, Total protein, ascorbic acid, cholinesterase, ALT, AST
GLP compliance:
no
Limit test:
yes

Test material

Constituent 1
Reference substance name:
L-Glutamic acid, N-coco acyl derivs., disodium salts
EC Number:
269-085-1
EC Name:
L-Glutamic acid, N-coco acyl derivs., disodium salts
Cas Number:
68187-30-4
IUPAC Name:
L-glutamic acid, N-coco acyl derivs., disodium salts

Test animals

Species:
rat
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
112 days
Frequency of treatment:
once per day
Doses / concentrations
Remarks:
Doses / Concentrations:
1200 mg/kg bw
Basis:
actual ingested
No. of animals per sex per dose:
no data.
Control animals:
yes
Details on study design:
112 treatment days. Relative organ weights investigated: liver, kidneys, spleen, adrenals, testes. Biochemical parameters: Hb, Total protein, ascorbic acid, cholinesterase, ALT, AST

Examinations

Statistics:
Student t-Test

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

Effect levels

Dose descriptor:
NOAEL
Effect level:
ca. 1 200 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male
Basis for effect level:
body weight and weight gain
mortality

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The NOAEL in this study was 1200 mg/kg bw.
Executive summary:

The repeated dose toxicity of N-cocoacyl glutaminic acid, sodium salts has been investigated in male albino rats. The animals received 0 or 1200 mg/kg bw per day for a treatment period of 112 days. No mortality or clinical signs were observed during treatment. No mortality occured. The body weight development statistically did not differ between dose and control group.

After necropsy the following parameters were assessed: relative organ weights of liver, kidneys, testes, adrenals, spleen. The following clinical chemical and hematological parameters were: hemoglobin, total serum protein, total liver protein, ascorbic acid in adrenals, testes and liver tissue. All values were statistically not different between control and dose groups or were within historical controls. The authors conclude that the NOAEL is 1200 mg/kg bw..

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