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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

Toxicological information

Repeated dose toxicity: oral

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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:
2015
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

Constituent 1
Chemical structure
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

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.