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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from secondary source

Data source

Reference
Reference Type:
other: Secondary source
Title:
Repeated oral toxicity study of test chemical
Author:
U. S. Environmental Protection Agency (EPA)
Year:
2001
Bibliographic source:
U. S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) Risk Assessment Division (RAD), 2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
To determine the repeated oral toxicity of test chemical in rats.
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUPAC name:Amides, coco, N-(hydroxyethyl)
Molecular formula: CH3(CH2)nCONHCH2CH2OH
Smiles: CCCCCCCCCCCC(=O)NCCO
InChI=1S/C14H29NO2/c1-2-3-4-5-6-7-8-9-10-11-14(17)15-12-13-16/h16H,2-13H2,1H3,(H,15,17)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
One daily dose administered for 28 days
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
28 days
Frequency of treatment:
5 days/week for 28 days
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (actual dose received)
Remarks:
Control
Dose / conc.:
70 mg/kg bw/day (actual dose received)
Dose / conc.:
250 mg/kg bw/day (actual dose received)
Dose / conc.:
750 mg/kg bw/day (actual dose received)
Remarks:
increased to 1500 after 14 days of treatment
No. of animals per sex per dose:
Test group: 10 male and 10 female rats used
Recovery group: five males and five females per dose level
Control animals:
yes, concurrent vehicle
Details on study design:
Not specified
Positive control:
Not specified

Examinations

Sacrifice and pathology:
GROSS PATHOLOGY: Yes

HISTOPATHOLOGY: Yes
Statistics:
Not specified

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Description (incidence):
None of the rats died
Body weight and weight changes:
no effects observed
Description (incidence and severity):
Body weight gain and total increase in body weight did not differ from control values.
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:
not specified
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
Biochemical parameters did not show any signs of irregulations. Slight alterations of phosphate in the highest group were noted and regarded as dose/compound -related but not as a critical effect.
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
no effects observed
Description (incidence and severity):
No significant compound-related gross pathology or tissue damage was noted.
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
Gonads were examined histologically and no effects were observed.
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

Effect levels

Dose descriptor:
NOAEL
Effect level:
750 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
mortality
body weight and weight gain
clinical biochemistry
gross pathology
histopathology: non-neoplastic
Remarks on result:
not determinable due to absence of adverse toxic effects

Target system / organ toxicity

Critical effects observed:
no

Applicant's summary and conclusion

Conclusions:
At the highest feasible repeated dose, 750 mg/kg, daily for 28 days, no lethal dose was attained indicating that the test chemical is not toxic in nature.
Executive summary:

A repeated dose toxicity study was performed in rats to determine the toxic nature of the test chemical. Ten male and 10 female rats were used during the 28 days study. The test substance was administered in olive oil, at doses of 750, 250 and 70 mg/kg body weight per day for 14 days. After 14 days the dose in the 750 mg/kg body weight test group was increased to 1500 mg/kg body weight per day. Recovery groups consisting of five males and five females per dose level were used to determine the reversibility of possible compound related findings. The compatibility of the test substance was evaluated after 28 days of treatment. None of the rats died. Body weight gain and total increase in body weight did not differ from control values and no significant compound-related gross pathology or tissue damage was noted. Biochemical parameters did not show any signs of irregulations. Slight alterations of phosphate in the highest group were noted and regarded as dose /compound -related but not as a critical effect. Gonads were examined histologically. At the highest feasible dose, 750 mg/kg, daily for 28 days, no lethal dose was attained indicating that the test chemical is not toxic in nature.