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EC number: 271-756-9 | CAS number: 68607-24-9
- 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- 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.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Quaternary ammonium compounds, benzyl C12-C16 (even numbered) -alkyldimethyl chlorides
- Molecular formula:
- C12-14H25-29-(CH3)2-C6H5-N.CL
- IUPAC Name:
- Quaternary ammonium compounds, benzyl C12-C16 (even numbered) -alkyldimethyl chlorides
- Reference substance name:
- Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chloride (i.e., benzyl C12-16 alkyl dimethyl ammonium chloride)
- IUPAC Name:
- Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chloride (i.e., benzyl C12-16 alkyl dimethyl ammonium chloride)
- Details on test material:
- containing ca. 50%
C12-16-benzyldimethylammonium chloride (CAS no.: 68424-85-1)
in water only.
Specification: C12-16 BKC (C12: 72.0%; C14: 27.7%; C16: 0.3%)
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Administration / exposure
- Route of administration:
- oral: gavage
- 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
- 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
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 3 mg/kg bw/day
- Basis for effect level:
- body weight and weight gain
- gross pathology
- mortality
Results (fetuses)
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day
- Basis for effect level:
- other: no treatment related 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
is not teratogenic in rabbits.
Maternal effects:
At 30 mg/kg bw/d:
- 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 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/d:
- 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 feces 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 bw/d:
no signs of maternal toxicity,
Teratogenic / embryotoxic effects:
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.
Litter and foetal evaluation:
The fluctuations noted in the mean number of corpora lutea,
implantation sites and post-implantation were slight and not
dose-related, they were consequently considered not to be
treatment-related.
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.
The percentage of male foetuses was considered similar among
the groups and the fetal body weight was unaffected by treatment.
External, soft tissue and skeletal observations in foetuses
and final fetal assessment:
The occurrence of some external and 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.
Concerning the skeletal observations, 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.
Conclusion: Test substance is 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/d (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/d. 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/d, being the highest tested dose.
Applicant's summary and conclusion
- Conclusions:
- The developmental toxicity of C12-16 ADBAC was investigated in accordance with OECD 414 in rabbits . The maternal NOAEL was 3 mg/kg/d and the developmental NOAEL was 30 mg/kg/d. No indication of developmental toxicity was found.
- Executive summary:
A guideline equivalent developmental toxicity study was conducted in rabbits. C12-16 ADBAC was administered to pregnant rabbits by gavage from Day 6 to 28 post-coitum at the dose-levels of 3, 10 or 30 mg/kg bw/day of active substance. The dose of 30 mg/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. Under the condition of the study, the NOAEL for maternal toxicity was 3 mg/kg bw/day while the NOAEL for embryo-foetal development was 30 mg/kg bw/day.
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