Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Repeated dose toxicity: oral
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:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicological properties of the test substance - surface active substances in the food industry
- Author:
- Zaitsev
- Year:
- 1 984
- Bibliographic source:
- 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)
- Deviations:
- not specified
- GLP compliance:
- no
- Limit test:
- yes
Test material
- 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
Constituent 1
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 d
- Frequency of treatment:
- once daily
Doses / concentrations
- Dose / conc.:
- 1 200 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- no data
- Control animals:
- yes
- Details on study design:
- Relative organ weight investigation: liver, kidneys, spleen, adrenals, testes
Biochemical parameters: Hb, totla protein, acsorbic acid, cholinesterase, ALT, AST
Examinations
- Observations and examinations performed and frequency:
- Mortality, clinical signs, body weight, food consumption
Biochemical parameters: Hb, Total protein, ascorbic acid, cholinesterase, ALT, AST
Behaviour - Sacrifice and pathology:
- Gross pathological observation
Relative organ weights investigated: liver, kidnesys, spleeen, adrenals, testes
Histophatological examination - 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 examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Endocrine findings:
- not specified
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- No treatment-related effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 200 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other:
- Remarks on result:
- other: no treatement-related adverse effects
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the sub-chronic NOAEL of the substance in rats was determined to be 1200 mg/kg bw/day
- Executive summary:
A study was conducted to determine the oral repeated dose toxicity of the substance according to a method similar to OECD Guideline 408. The study was conducted in male albino rats. The animals received the test substance by oral gavage at 0 or 1200 mg/kg bw/day for a period of 112 d. No mortality or clinical signs were observed during treatment. The body weight development did not statistically differ between the treated and the control groups. The following clinical chemical and hematological parameters were recorded: hemoglobin, total serum protein, total liver protein, ascorbic acid in adrenals, testes and liver tissue. None of the values were statistically significant between control and dose groups or were within historical values. After necropsy, the relative organ weights of liver, kidneys, testes, adrenals and spleen were measured and did not reveal any difference between groups. Under the study conditions, the sub-chronic NOAEL of the substance in rats was determined to be 1200 mg/kg bw/day (Zaitsev, 1984).
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