Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 939-616-8 | CAS number: 68391-03-7
- 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
- Flammability
- Explosiveness
- Oxidising properties
- 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
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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
- Report date:
- 2005
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:
- Quaternary ammonium compounds, benzyl C12-C16 (even numbered)-alkyldimethyl chlorides
- EC Number:
- 939-253-5
- Molecular formula:
- C12-16H25-33-(CH3)2-C6H5-N.CL
- IUPAC Name:
- Quaternary ammonium compounds, benzyl C12-C16 (even numbered)-alkyldimethyl chlorides
- Test material form:
- liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- KBL New Zealand White, Specific Pathogen Free (S.P.F.).
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Laboratories (Elevage Scientifique des Dombes, Châtillon-sur- Chalaronne, France).
- Sex: Female
- Age/weight at study initiation: 18-20 weeks; mean body weight of 3451 g (range: 2950 g to 4095 g).
- Number of animals per group:22
The animals were individually housed in stainless steel cages, in a barriered rabbit unit, under specific pathogen free (SPF) standard laboratory conditions.
. temperature : 18 ± 3°C
. relative humidity : 50 ± 20%
. light/dark cycle : 8h dark/16h light (5:00 - 21:00)
. ventilation : about 8 to 10 cycles/hour of filtered, non-recycled air.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- - Concentration in vehicle: 0, 0.3, 1 and 3 mg test substance/mL The test item dosage forms were prepared daily and stored at room temperature prior to use.
- Chemical analysis: The concentration of samples taken from each control and test substance dosage form prepared for use on the first day of treatment and on the last day of treatment was determined.
- Total volume applied: The quantity of dosage form administered to each animal was adjusted according to the most recently recorded body weight. A constant dosage-volume of 10 mL/kg/day was used. - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Animals were mated at the breeder's facilities. The day of confirmed mating (visual assessment) was designated as day 0 post-coitum (p.c.) or day 0 of gestation (GD 0). The animals were supplied to CIT on day 1 post-coitum; consequently they were acclimated for a period of 5 days before the beginning of the treatment period.
- Duration of treatment / exposure:
- Day 6 to 28 post coitum
- Frequency of treatment:
- Daily
- Duration of test:
- 23 d
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:
- The dose-levels were selected following the results of a previously conducted range finding study (CIT/Study No. 26147RSL): no maternal toxic effects were recorded at 3, 10 or 30 mg a.s./kg/day, but marked toxicity was observed at 50 and 100 mg/kg/day, which resulted in the deaths of a high number of females in both high dosegroups. At these two latter dose-levels, clinical signs (orange coloured urine, soft faeces, soiled urogenital area, emaciated appearance…), body weight loss, lower food consumption and reddish colour of the stomach mucosa were observed in most females. Consequently, the dose-levels of 3, 10 and 30 mg/kg/day were selected for the main study.
Examinations
- Maternal examinations:
- - Body weight Yes: each female on days 2, 4, 5, 6, 9, 12, 15, 18, 22, 26 and 29 post-coitum.
- Food consumption: The quantity of food consumed by each female was recorded for days 2-4, 4-5, 5-6, 6-9, 9-12, 12-15, 15-18, 18-22, 22-26 and 26-29 post-coitum. Any obvious spillage of food was documented.
- Clinical signs: Morbidity and mortality. From the start of the treatment period, each animal was observed at least once a day, at approximately the same daily time for the recording of clinical signs (including evidence of abortion/desorption). - 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
- Details on results:
- At 30 mg/kg/day:
- three females died and two females were prematurely sacrificed for ethical reasons or abortion,
- the relevant clinical signs concerned the deceased females and two prematurely sacrificed females. No other clinical signs were noted in females from this group.
- body weight gain was transiently reduced (GD 9-12, -70% below the control, p<0.05) but returned to normal values thereafter,
- the necropsies revealed in 8/22 females: accentuated lobular pattern in the liver, pale liver, whitish areas and/or blackish deposits and/or oedema 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/day:
- there were no deaths. Reduction of maternal body weight gain and food consumption did not reach statistical significance,
- 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 faeces from day 26 post- coitum,
- 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,
At 3 mg/kg/day:
no signs of maternal toxicity.
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
- 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)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- systemic toxicity
- Effect level:
- 3 mg/kg bw/day
- Based on:
- act. ingr.
- Basis for effect level:
- gross pathology
- other: based on dilated gall bladder, accentuated lobular pattern in liver, transient but severe body weight gain reduction on GD 9-12 and mortality at top dose
- Remarks on result:
- other: Blackish content in stomach and intestines is indicative of local corrosive effects of test substance related to the dosing of substance by gavage
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
- 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:
Range-finding study:
Groups of six mated female rabbits received daily oral administration at 0 (vehicle, purified water), 3, 10 or 30 mg C12 -16 ADBAC/kg bw/day from day 6 to day 28 post-coitum. In the absence of maternal toxicity, additional groups with dose levels 0, 50 and 100 mg C12 -16 ADBAC/kg bw/day were added.
C12 -16 ADBAC from Day 6-28 p.c. produced marked maternal toxicity at 50 and 100 mg/kg/day shown by high number of deceased females and severe clinical conditions in most animals.
At 30 mg/kg bw/day, slightly high mean number of post-implantation loss associated with slightly low mean number of live foetuses were recorded. No maternal toxicity or effects on litter data parameters were noted at 3 and 10 mg/kg/day.
Based on these results, the 30 mg/kg bw/day dose-level was chosen as the high dose-level in the further developmental toxicity study (CIT Study No. 26148 RSL).
Main study:
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 NOAEL for maternal toxicity and embryo-foetal development was established at 3 and 30 mg a.i./kg bw/day respectively in rabbits.
- Executive summary:
A study was conducted to determine the developmental toxicity and teratogenicity of the test substance, C12-16 ADBAC (49.9% active in water), 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 0, 3, 10 or 30 mg a.i./kg bw/day. Based on the results of a range-finding study, the test subsatnce was administered as a solution by daily oral administration at 3, 10 and 30 mg a.s./kg/day from day 6 to day 28 post-coitum. One group of 22 females received the vehicle alone (purified water) under the same experimental conditions and acted as a control group. A standard dosage-volume of 10 mL/kg body weight was used for each group. Food consumption and body weight were recorded daily throughout the study period. Clinical signs were checked each day. On day 29 post-coitum, all the surviving dams were sacrificed and subjected to a macroscopic post-mortem examination. The foetuses 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 foetuses were recorded. The foetuses were weighed and submitted to external examination. 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. 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 and/or oedema 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, also an indication of corresponding lower food consumption was observed. 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). Blackish content in stomach and intestines was considered to be indicative of local corrosive effects of the test substance. 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 NOAEL for maternal toxicity and embryo-foetal development was established at 3 and 30 mg a.i./kg bw/day respectively in rabbits (Gaoua, 2005).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Although ECHA is providing a lot of online material in your language, part of this page is only in English. More about ECHA’s multilingual practice.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
the-echa-website-uses-cookies
find-out-more-on how-we-use-cookies