Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not specified.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
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:
Lot numbers:
Bardac-20: B35307 (25%)
Bardac-LF: B3414 (50%)

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
Adult female rats were mated with young adult males and detection of the vaginal sperm plug was considered to occur on day 0 of gestation.
Duration of treatment / exposure:
GD 6 to 15
Frequency of treatment:
Once daily.
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
10 mg/kg bw/day (nominal)
Dose / conc.:
25 mg/kg bw/day (nominal)
Dose / conc.:
50 mg/kg bw/day (nominal)
No. of animals per sex per dose:
Bardac-20:
10 mg/kg bw/day - 25 females
25 and 50 mg/kg bw/day - 24 females

Bardac-LF:
10 mg/kg bw/day - 26 females
25 mg/kg bw/day - 23 females
50 mg/kg bw/day - 26 females
Control animals:
yes, concurrent vehicle
other: Aspirin (250 mg/kg bw/day)

Examinations

Maternal examinations:
Body weights were recorded on days 0, 6, 11, 15 and 20 of gestation. All animals were observed daily for appearance and behaviour with particular attention to food consumption and weight, in order to rule out any abnormalities which may have occurred as a result of anorexic effects.
Ovaries and uterine content:
Uterine contentts were examined and the number of implantation sites for each uterine horn were recorded. Number of live pups, dead pups and resorption sies were also recorded. The weight of each pup and number of corpora lutea was recorded.
Fetal examinations:
The urogenital tract was examined for signs of gross abnormality. One third of the pups in each litter were randomly chosen and fixed in Bouin's solution and these animals were examined for soft tissue abnormalities. All pups showing any gross abnormality were included in this preparation.
Statistics:
Incidence of occurrence ratios of treated groups were compared with the ratio for the control group using confidence Belts for Proportions (confidence coefficient of 0.95). Fetus weights were evaluated by analyses of variance and compared to the control value sing Scheffe's test.

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

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

Maternal developmental toxicity

Number of abortions:
no effects observed
Pre- and post-implantation loss:
not specified
Total litter losses by resorption:
effects observed, non-treatment-related
Early or late resorptions:
not specified
Changes in pregnancy duration:
not specified
Description (incidence and severity):
Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed
Changes in number of pregnant:
not specified

Effect levels (maternal animals)

Key result
Dose descriptor:
NOEL
Effect level:
50 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
body weight and weight gain
number of abortions
total litter losses by resorption

Results (fetuses)

Fetal body weight changes:
no effects observed
Description (incidence and severity):
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified
Reduction in number of live offspring:
not specified
Changes in sex ratio:
not specified
Changes in litter size and weights:
not specified
Changes in postnatal survival:
not specified
External malformations:
no effects observed
Skeletal malformations:
no effects observed
Visceral malformations:
effects observed, non-treatment-related
Description (incidence and severity):
The most common abnormalities were hemorrhagic thorax and abdomen and gastroschisis. The incidence of accurrence was no greater in substance ttreated groups than in the controls.

Effect levels (fetuses)

Key result
Dose descriptor:
NOEL
Effect level:
50 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
external malformations
skeletal malformations
visceral malformations

Overall developmental toxicity

Key result
Developmental effects observed:
no
Lowest effective dose / conc.:
50 mg/kg bw/day

Applicant's summary and conclusion

Conclusions:
No teratological findings could be ascribed to the substances employed at doses up to 50 mg/kg bw/day in rats when dosed during GD 6 to 15.
Executive summary:

The substance was administered to pregnant rats for 10 days at doses of 10, 25 and 50 mg/kg bw/day. There were no deleterious effects on gestation, but the substances did cause more dams to resorb one or more fetuses at the 50 mg/kg bw/day dose level. No teratological findings could be ascribed to the substances employed at doses up to 50 mg/kg bw/day in rats when dosed during GD 6 to 15.