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EC number: 203-232-2 | CAS number: 104-74-5
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from authoritative database
Data source
Reference
- Reference Type:
- other: Authoritative database
- Title:
- Repeated dose oral toxcity study of the test chemical
- Author:
- U.S. National Library of Medicine.
- Year:
- 2 015
- Bibliographic source:
- HSDB
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Subchronic repeated dose oral toxicity study for the test chemical was conducted in CD-1 mice.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Didecyldimethylammonium chloride
- EC Number:
- 230-525-2
- EC Name:
- Didecyldimethylammonium chloride
- Cas Number:
- 7173-51-5
- Molecular formula:
- C22H48N.Cl
- IUPAC Name:
- Didecyldimethylammonium chloride
- Details on test material:
- - Name of test material (as cited in study report): Didecyldimethylammonium chloride
- Molecular formula: C22-H48-N.Cl
- Molecular weight: 362.081
- Substance type: Organic
- Physical state: liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on species / strain selection:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Route of administration:
- oral: feed
- Details on route of administration:
- No data
- Vehicle:
- other: diet
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The test chemical was mixed with feed at dose level of 0, 20, 60, 120, 200 or 600 mg/Kg/day
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): Feed
- Concentration in vehicle: 0, 20, 60, 120, 200 or 600 mg/Kg/day
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 89 day (males) or 90 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm
- Remarks:
- 0 mg/Kg/day
- Dose / conc.:
- 100 ppm
- Remarks:
- approx. equivalent to 20 mg/kg bw/day
- Dose / conc.:
- 300 ppm
- Remarks:
- approx. equivalent to 60 mg/kg bw/day
- Dose / conc.:
- 600 ppm
- Remarks:
- approx. equivalent to 120 mg/kg bw/day
- Dose / conc.:
- 1 000 ppm
- Remarks:
- approx. equivalent to 200 mg/kg bw/day
- Dose / conc.:
- 3 000 ppm
- Remarks:
- approx. equivalent to 600 mg/kg bw/day
- No. of animals per sex per dose:
- 15/sex/group
- Control animals:
- yes, concurrent vehicle
- not specified
- Details on study design:
- not specified
- Positive control:
- not specified
Examinations
- Observations and examinations performed and frequency:
- Clinical symptoms, body weight and mortality
- Sacrifice and pathology:
- GROSS PATHOLOGY: Not specified
HISTOPATHOLOGY: Yes - Other examinations:
- Not specified
- Statistics:
- Not specified
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- At 3000 ppm animals exhibited general ill health with hunched posture, emaciation.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- All animals at 3000 ppm died except for one male. Death was attributed to treatment related malnutrition and dehydration
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- At 1000 ppm, males showed decreased body weight gain. Body weight effects were minimal at 1000 ppm
- 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:
- not specified
- 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:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- at 3000 ppm animals exhibited distension and/or watery contents of the intestines.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 200 other: mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- histopathology: non-neoplastic
- mortality
- Remarks on result:
- other: No toxic effects were observed
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for the test chemical was considered to be 200 mg/kg bw/day in CD-1 mice after repeated exposure via oral route.
- Executive summary:
In a subchronic or Prechronic exposure study the test chemical was fed to CD-1 mice (15/sex/group) in the diet at 0 (vehicle = diet), 100, 300, 600, 1000 or 3000 ppm daily for 89 day (males) or 90 days (approx. equivalent to0, 20, 60, 120, 200 and 600 mg/kg bw/day). At 1000 ppm (200 mg/Kg/day), males showed decreased body weight gain. All animals at 3000 ppm (600 mg/Kg/day) died except for one male, also animals exhibited general ill health with hunched posture, emaciation, distension and/or watery contents of the intestines. Death was attributed to treatment related malnutrition and dehydration. Body weight effects were minimal at 1000 ppm, whereas death occurred at 3000 ppm in both sexes. Thus, the No Observed Adverse Effect Level (NOAEL) for the test chemical was considered to be 200 mg/kg bw/day in CD-1 mice after repeated exposure via oral route.
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