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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Not spcified.
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
According to 'Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics' published by the Association of Food and Drugs Officials of the United States.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyldioctylammonium chloride
EC Number:
226-901-0
EC Name:
Dimethyldioctylammonium chloride
Cas Number:
5538-94-3
Molecular formula:
C18H40NCl
IUPAC Name:
dimethyldioctylazanium chloride
Test material form:
liquid
Specific details on test material used for the study:
Quat LF-50
50% active, but the test concentrations employed were based on 100% actives.

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on exposure:
The substance (4 ml) was applied daily to the skin to cover 10% of the body surface for 20 consecutive days.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Twenty days of repeated daily applications.
Frequency of treatment:
Daily.
Doses / concentrationsopen allclose all
Dose / conc.:
0.002 other: based on 100% actives
Dose / conc.:
0.001 other: based on 100% actives
Dose / conc.:
0 other: based on 100% actives
No. of animals per sex per dose:
Two/sex/dose
Control animals:
yes, concurrent no treatment
Positive control:
None.

Examinations

Observations and examinations performed and frequency:
Food, bodyweight, fluid intake, excretions and behaviour and appearance were oberved. Blood and urine studies were performed at the begining of the test, at the 20 day interval and prior to autopsy.
Sacrifice and pathology:
Following sacrifice tissues were collected for gross and histological examinations. The tissues collected were skin, thyroid, lungs, heart, liver, spleen, adrenal, kidney, ovary, uterus and testes. Histopathology was examined in skin, thyroid, liver, lung, spleen, heart, adrenal, testes, ovary and fallopian tubes.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Dermal irritation:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
no effects observed
Ophthalmological findings:
not examined
Haematological findings:
no effects observed
Clinical biochemistry findings:
not examined
Urinalysis findings:
no effects observed
Behaviour (functional findings):
no effects observed
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
no effects observed
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed

Effect levels

Key result
Dose descriptor:
NOEL
Effect level:
0.002 other: %
Based on:
test mat.
Sex:
male/female
Basis for effect level:
behaviour (functional findings)
body weight and weight gain
clinical signs
dermal irritation
gross pathology
haematology
histopathology: non-neoplastic
mortality
urinalysis
Remarks on result:
not determinable due to absence of adverse toxic effects

Applicant's summary and conclusion

Conclusions:
The substance caused no significant toxicity or pathology in rabbits following daily dermal exposure to concentrations of 0.002, 0.001 and 0.00025%.
Executive summary:

In a subacute toxicity study the substance was administered to male and female (2/sex/dose) rabbits (strain unspecified) by dermal application levels of 0.00025, 0.001 and 0.002% of a 100% active solution. At no time during the study were there any aberrations in food or fluid intake, excretions, appearance or behaviour noted. All blood and urine findings were within normal limits. Gross and histopathological examinations of significant organs and tissues were all unremarkable. The NOEL is identified to 0.002%.