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Description of key information

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Publication; RA study
Justification for type of information:
Refer to the section 13 of the IUCLID dataset for details on the read across justification. The repeated dose toxicity study: oral with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
Reason / purpose for cross-reference:
read-across: supporting information
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
Species:
rat
Strain:
not specified
Sex:
male
Route of administration:
oral: gavage
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
112 d
Frequency of treatment:
once daily
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 weights investigated: liver, kidneys, spleen, adrenals, testes.
Biochemical parameters: Hb, Total protein, ascorbic acid, cholinesterase, ALT, AST
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, kidneys, spleen, adrenals, testes
Histophatological examination
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 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
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
Key result
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
Key result
Critical effects observed:
no
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 read-across substance L-glutamic acid, N-coco acyl derivs., monosodium salts 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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 200 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
a short-term toxicity study does not need to be conducted because a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration
Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
a short-term toxicity study does not need to be conducted because a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration
Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
a short-term toxicity study does not need to be conducted because a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration
Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
a short-term toxicity study does not need to be conducted because a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A study was conducted to determine the oral repeated dose toxicity of the read-across substance L-glutamic acid, N-coco acyl derivs., monosodium salts 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).

Justification for classification or non-classification

Based on the results of a sub-chronic repeated dose toxicity study with the read-across substance L-glutamic acid, N-coco acyl derivs., monosodium salts

, no classification is warranted for repeat dose toxicity according to EU CLP (1272/2008) criteria.

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