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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

In a subchronic repeated dose toxicity study in male albino rats performed with L-Glutamic acid, N-coco acyl derivs., disodium salts (CAS 68187-30-4) , a NOAEL >1200 mg/kg bw was concluded.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
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:
Klimisch criteria. 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.
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
Species:
rat
Strain:
not specified
Sex:
male
Route of administration:
oral: gavage
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
112 days
Frequency of treatment:
once per day
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
Statistics:
Student t-Test
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
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
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:
other: No treatment-related adverse effects observed up to and including the highest dose.
Critical effects observed:
not specified
Conclusions:
The NOAEL in this study was 1200 mg/kg bw.
Executive summary:

The repeated dose toxicity of N-cocoacyl glutaminic acid, sodium salts, a close homologue of the registered substance, 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.

Although the study has its restrictions in terms of documentation and parameters assessed, the result reflects the fact that during hydrolysis the test substance forms two physiological cleavage products: Coco fatty acids and glutamic acid. Both are natural constituents of conventional foods which are consumed on a gram per day level. Under these circumstances it is scientifically not justified to repeat the subchronic study in order to fill potantial data gaps (histopathology, missing organ weights and clinical chemical and hematological parameter, missing female animals). Therefore, the NOAEL of 1200 mg/kg bw is considered to be a valoid point of departure.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 200 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Although the study has some restrictions, it is considered to fulfill basic requirements of data reporting.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The repeated dose toxicity of N-cocoacyl glutaminic acid, sodium salts, a close homologe of the registered substance (see justification for read across below), 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. The body weight development did not differ statistically 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 was >1200 mg/kg bw.

 

Although the study has its limitations in terms of documentation and parameters assessed, the result reflects the fact that during hydrolysis the test substance forms two physiological cleavage products: Coco fatty acids and glutamic acid. Both are natural constituents of conventional foods which are consumed on a gram per day level. Under these circumstances it is scientifically not justified to repeat the subchronic study in order to fill potantial data gaps (histopathology, missing organ weights and clinical chemical and hematological parameter, missing female animals). Therefore, the NOAEL of 1200 mg/kg bw is considered to be a valid point of departure.

 

The read across justification is given in an extra rationale document.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result, the substance is not classified for repeated dose toxicity under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.