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EC number: 939-253-5 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
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- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- batch number is not presented for the vehicle (purified water) in the study report; autolysed foetuses were not sexed at the time of hysterectomy and head sections were archived in the same way as brain sections.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- batch number is not presented for the vehicle (purified water) in the study report; autolysed foetuses were not sexed at the time of hysterectomy and head sections were archived in the same way as brain sections.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Benzyldimethyloctylammonium chloride
- EC Number:
- 213-502-1
- EC Name:
- Benzyldimethyloctylammonium chloride
- Cas Number:
- 959-55-7
- Molecular formula:
- C17-H30-N.Cl
- IUPAC Name:
- benzyl-dimethyl-octylazanium;chloride
- Reference substance name:
- Benzyl(decyl)dimethylammonium chloride
- EC Number:
- 213-521-5
- EC Name:
- Benzyl(decyl)dimethylammonium chloride
- Cas Number:
- 965-32-2
- Molecular formula:
- C19H34N.Cl
- IUPAC Name:
- benzyl-decyl-dimethylazanium;chloride
- Reference substance name:
- Benzododecinium chloride
- EC Number:
- 205-351-5
- EC Name:
- Benzododecinium chloride
- Cas Number:
- 139-07-1
- Molecular formula:
- C21H38N.Cl
- IUPAC Name:
- Benzenemethanaminium, N-dodecyl-N,N-dimethyl-, chloride
- Reference substance name:
- Miristalkonium chloride
- EC Number:
- 205-352-0
- EC Name:
- Miristalkonium chloride
- Cas Number:
- 139-08-2
- Molecular formula:
- C23H42N.Cl
- IUPAC Name:
- benzyl-dimethyl-tetradecylazanium;chloride
- Reference substance name:
- Cetalkonium chloride
- EC Number:
- 204-526-3
- EC Name:
- Cetalkonium chloride
- Cas Number:
- 122-18-9
- Molecular formula:
- C25H46N.Cl
- IUPAC Name:
- benzyl-hexadecyl-dimethylazanium;chloride
- Reference substance name:
- Benzyldimethyl(octadecyl)ammonium chloride
- EC Number:
- 204-527-9
- EC Name:
- Benzyldimethyl(octadecyl)ammonium chloride
- Cas Number:
- 122-19-0
- Molecular formula:
- C27H50N.Cl
- IUPAC Name:
- benzyl-dimethyl-octadecylazanium;chloride
- Reference substance name:
- Benzyldimethyloleylammonium chloride
- EC Number:
- 253-363-4
- EC Name:
- Benzyldimethyloleylammonium chloride
- Cas Number:
- 37139-99-4
- Molecular formula:
- C27H48N.Cl
- IUPAC Name:
- benzyl-dimethyl-octadec-9-enylazanium;chloride
- Reference substance name:
- Other constituents
- Molecular formula:
- Not applicable for these constituents.
- IUPAC Name:
- Other constituents
- Details on test material:
- This is formulation of 49.2% of the test substance in water.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Administration / exposure
- Route of administration:
- oral: gavage
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Day 6 to 28 post coitum
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- vehicle alone
- Dose / conc.:
- 3 mg/kg bw/day
- Dose / conc.:
- 10 mg/kg bw/day
- Dose / conc.:
- 30 mg/kg bw/day
- No. of animals per sex per dose:
- 22 mated females per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Sex: female
Duration of test: GD 6-28
Examinations
- Maternal examinations:
- - Food consumption and body weight were recorded at designated intervals.
- Clinical signs were checked each day. - Ovaries and uterine content:
- - On Day 29 post-coitum, all the surviving dams were sacrificed and subjected to a macroscopic post-mortem examination. A gross examination of placentas was also performed. The fetuses were removed by hysterectomy and the uterus weighed. The net body weight gain was calculated. The litter parameters, namely, the number of corpora lutea, implantation sites, early and late resorptions, dead and live fetuses were recorded. The fetuses were weighed and submitted to external examination.
- Fetal examinations:
- - The live fetuses were killed and then subjected to a fresh dissection and detailed examination of soft tissue, including body, head and brain. The sex was determined. The carcasses were then fixed and the skeletons (including cartilage) stained and examined.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- At 30 mg/kg bw/day:
- the relevant clinical signs concerned the deceased females and two prematurely sacrificed females. No other clinical signs were noted in females from this group.
At 10 mg/kg bw/day:
- there were no relevant clinical signs except for two females with blood in the bedding on Days 22 and 23 post-coitum or absence of feces from Day 26 post-coitum - Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- At 30 mg/kg bw/day:
- three females died and two females were prematurely sacrificed for ethical reasons or abortion.
At 10 mg/kg bw/day:
- there were no deaths. - Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- At 30 mg/kg bw/day:
- body weight gain was transiently reduced (GD 9-12, -70% below the control, p<0.05) but returned to normal values thereafter.
At 10 mg/kg bw/day:
- reduction of maternal body weight gain did not reach statistical significance. - Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- At 10 mg/kg bw/day:
- reduction of food consumption did not reach statistical significance. - Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- At 30 mg/kg bw/day:
- the necropsies revealed in 8/22 females: accentuated lobular pattern in the liver, pale liver, whitish areas and/or blackish deposits and/or edema in the stomach mucosa, reddish or brownish foci on the lungs, blackish contents in the intestines, dilated intestines and dilated gall bladder.
At 10 mg/kg bw/day:
- the necropsies revealed in 5/22 females: dilated gall bladder, accentuated lobular pattern.
- pale liver, brownish or reddish foci on the lungs, blackish deposit on the stomach mucosa. - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- no effects observed
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The fluctuations recorded for the mean number of resorptions (early or late) and the mean number of dead foetuses and consequently for the percentages of post-implantation loss were also not considered to be treatment-related, as they were minimal and not dose-related.
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The fluctuations recorded for the mean number of resorptions (early or late) and the mean number of dead foetuses and consequently for the percentages of post-implantation loss were also not considered to be treatment-related, as they were minimal and not dose-related.
- Dead fetuses:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The fluctuations recorded for the mean number of resorptions (early or late) and the mean number of dead foetuses and consequently for the percentages of post-implantation loss were also not considered to be treatment-related, as they were minimal and not dose-related.
- Changes in pregnancy duration:
- not examined
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not examined - Changes in number of pregnant:
- not examined
- Other effects:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The fluctuations noted in the mean number of corpora lutea and implantation sites were slight and not dose-related, they were consequently considered not to be treatment-related.
- Details on maternal toxic effects:
- At 3 mg/kg bw/day:
- no signs of maternal toxicity
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- systemic toxicity
- Effect level:
- 3 mg/kg bw/day
- Based on:
- act. ingr.
- Basis for effect level:
- body weight and weight gain
- clinical signs
- gross pathology
- mortality
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- reproductive toxicity
- Effect level:
- 30 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: no reproductive toxicity observed
Maternal abnormalities
- Key result
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- other: general toxicity, no effects observed on reproductive organs
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): no effects observed - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The occurrence of some external malformations throughout all treated groups, including the controls, did not suggest any substance-related origin because of their low incidence, absence of dose-relationship and/or statistical significance.
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No relevant malformations was noted but the presence of a full supernumerary 13th pair of ribs (as a foetal variation), was markedly increased at 10 and 30 mg/kg bw/day. These differences in foetal or litter incidence, which were within background data, were most probably due to a low control value. The incidence of one other skeletal variation (unossified 5th sternebra) was significantly greater but in the low dose-group only.
- Visceral malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The occurrence of some soft tissue malformations throughout all treated groups, including the controls, did not suggest any substance-related origin because of their low incidence, absence of dose-relationship and/or statistical significance.
- Details on embryotoxic / teratogenic effects:
- Conclusion:
There were no treatment-related effects on litter data parameters and no treatment-related findings upon external, visceral or skeletal observation in any of the dose groups. The test substance was not teratogenic in rabbits.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- general and developmental toxicity
- Effect level:
- 30 mg/kg bw/day
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment related developmental effect up to the highest dose
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
Result:
The test substance was not teratogenic in rabbits.
- LO(A)EL maternal toxic effects:
10 mg/kg bw/d, based on necropsy findings in 5/22 animals. Incidence was increased to 8/22 at 30 mg/kg bw/day (dilated gallbladder 3/22, accentuated lobular pattern liver 3/22).
Foci (reddish/brownish) in the lung was also observed in 2 females, but also in view of findings in range finding study and parallel study with comparable compound, this can be caused by inadvertent presence of substance into the airways and not attributable to systemic toxicity. Incidence was not increased in the top-dose group. There is an indication of lower body weight gain, correlating to a lower food consumption, but that was not statistical significant and in the high-dose goup not different from the mid-dose group. Blackish content in stomack and intestines is indicative of local corrosive effects of test substance.
- NO(A)EL maternal toxic effects:
3 mg/kg bw/day. There seems to be a dose-response related increase in necropsy findings in stomach, intestine and liver. Dilated gallbladder incidence was not increased in highest dose group compared to mid-dose.
- LO(A)EL embryotoxic / teratogenic effects:
Based on the number of foetuses presenting malformations or variations and in the absence of a treatment-related increase of such observation, the embryo-fetal development was not considered to be affected by treatment.
- NO(A)EL embryotoxic / teratogenic effects:
30 mg/kg bw/day, being the highest tested dose.
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the rabbit NOAEL for maternal toxicity was 3 mg a.i./kg bw/day while the rabbit NOAEL for embryo-foetal development was considered to be 30 mg a.i./kg bw/day.
- Executive summary:
A study was conducted to determine the developmental toxicity and teratogenicity of the test substance according to OECD Guideline 414 and US EPA OPPTS 870.3700, in compliance with GLP. The substance was administered to pregnant rabbits by gavage from Day 6 to 28 post-coitum at the dose-levels of 3, 10 or 30 mg a.i./kg bw/day. The dose of 30 mg a.i./kg bw/day caused the death of three females, severe clinical condition or abortion in two other females and transient, lower maternal body weight gain. Necropsies revealed in 8/22 females accentuated lobular patterns in the liver, whitish areas and/or blackish deposits in the stomach mucosa and dilated intestines. At 10 mg/kg bw/day, relevant necropsy findings were noted in 5/22 females (dilated gall bladder, accentuated lobular pattern, pale liver, brownish or reddish foci on the lungs, blackish deposit on the stomach mucosa). No maternal toxicity or effects on litter data parameters or embryo-foetal development were noted at 3 mg/kg bw/day. Moreover, there were no effects on litter data parameters and no treatment-related findings upon external, visceral or skeletal observation in any of the dose groups up to 30 mg a.i./kg bw/day. Under the study conditions, the rabbit NOAEL for maternal toxicity was 3 mg a.i./kg bw/day while the rabbit NOAEL for embryo-foetal development was considered to be 30 mg a.i./kg bw/day (Gaoua, 2005).
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