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EC number: 619-057-3 | CAS number: 94667-33-1
- 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
- Study period:
- February - March 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 83-3 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- DDAC
- IUPAC Name:
- DDAC
- Reference substance name:
- Didecyldimethylammonium chloride
- EC Number:
- 230-525-2
- EC Name:
- Didecyldimethylammonium chloride
- Cas Number:
- 7173-51-5
- Molecular formula:
- C22 H48 N.Cl
- IUPAC Name:
- N-decyl-N,N-dimethyldecan-1-aminium chloride
- Reference substance name:
- N,N-Didecyl-N,N-dimethylammonium Chloride
- IUPAC Name:
- N,N-Didecyl-N,N-dimethylammonium Chloride
- Reference substance name:
- 1-Decanaminium, N-decyl-N,N-dimethyl-, chloride
- IUPAC Name:
- 1-Decanaminium, N-decyl-N,N-dimethyl-, chloride
- Reference substance name:
- Bardac 2280
- IUPAC Name:
- Bardac 2280
- Details on test material:
- The test material was Bardac 2280 (Didecyldimethylammonium Chloride; DDAC, in aqueous/alcohol solution), supplied by Lonza Inc. The substance was described as a very viscous honey coloured liquid.
DDAC is hydrolytically and photolytically stable under the conditions of this study and has been shown to be stable in aqueous, alcohol and alcohol/aqueous solutions for extended periods, e.g. at least seven years under standard laboratory conditions.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- The test animals were 10-week old female Sprague-Dawley (Crl:CD BR) rats, obtained from Charles River Breeding Laboratories, MI, USA. The animals were quarantined for approximately 2 weeks. Representative animals were subject to faecal screening, serum viral antibody analysis and histological examination of selected organs. Rats were housed in same-sex pairs in stainless steel wire mesh cages during acclimatisation. Rats were housed singly thereafter (except during mating). Food (Purina Certified Ground Rodent Chow) and municipal water were provided ad libitum. Temperature was maintained at 66-77°F, and relative humidity 40-70%, with a 12 hour light/dark cycle.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Millipore water
- Details on exposure:
- The test substance (in deionised water) was administered by gavage to timed pregnant dams (GD 6-15). The concentration of the test substance in the vehicle was 0, 0.2, 2.0 and 4.0 mg/ml. Dose preparations were corrected for percent active ingredient. Solutions were prepared twice during the study. Dose volume was maintained at 5 ml/kg bw. Administered volumes were adjusted on the basis of the most recent body weight of each animal.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Stability and homogeneity studies were conducted, and solutions were analysed for test substance concentration using gas-chromatography with Nitrogen-Phosphorous detection. The dosing solutions were demonstrated to be homogenous, stable for at least 12 days when stored at room temperature, and within 97.0 to 103.85 of nominal.
- Details on mating procedure:
- Rats were mated 1:1 in stainless steel wire mesh cages. Females were checked daily in the morning for copulatory plugs, and cage boards were checked twice daily for dropped copulatory plugs. The date a plug was found was designated gestational day 0. Plug-positive females were singly housed.
- Duration of treatment / exposure:
- Days 6 - 15 of gestation
- Frequency of treatment:
- Once daily during exposure period
- Duration of test:
- Until Day 21 of gestation
- No. of animals per sex per dose:
- 25 females/group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- 25 plug-positive females were assigned to each treatment group by a computer-generated randomisation procedure stratified by body weight on GD 0, so that all groups were equivalent in mean body weight and body weight range. Dose levels for the study were chosen based on a previous range-finding study.
Examinations
- Maternal examinations:
- The rats were observed twice daily for clinical signs and mortality during dosing, and daily thereafter. Bodyweights were recorded on GD 0, 6, 9, 12, 15, 18 and 21 of gestation. Food consumption was determined at 3 day intervals throughout gestation.
Gross necropsy was performed on all rats at terminal sacrifice (GD 21). The gravid uterus, ovaries (including corpora lutea), cervix, vagina, and abdominal and thoracic organs were examined grossly. The lumen of the oesophagus, stomach and trachea were examined for any signs of irritation from the dosing solution. The uterus was examined externally for signs of haemorrhage before removal. Organ weights were obtained for the liver and gravid uterus. - Ovaries and uterine content:
- The number of corpora lutea and the number and status of implantation sites were recorded. All live and dead foetuses and resorption sites were noted and recorded. Uteri from females that appeared nongravid were placed in 10% ammonium sulphide solution for detection of early resorptions
- Fetal examinations:
- All live foetuses were weighed, sexed and examined for external malformations. Half the foetuses were used for skeletal examinations using alizarin red S staining, and half were used for visceral examinations. These foetuses were decapitated and their heads fixed in Bouin's solutions for examination of craniofacial features.
- Statistics:
- Levene’s test for equal variances, analysis of variance, and t-tests with Bonferroni probabilities for pairwise comparisons. Nonparametric data were analyzed with Kruskal-Wallis test followed by Mann-Whitney U test when appropriate. Incidence data were compared using Fisher’s Exact Test.
- Indices:
- No information available.
- Historical control data:
- No information available.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Audible respiration and gasping was observed at 20 mg a.s./kg bw/d. Audible respiration was observed at 10 mg a.s./kg bw/d.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced body weight gain was observed at 20 mg a.s./kg bw/d.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced food consumption was observed at 20 mg a.s./kg bw/d.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- There were no treatment-related effects on gravid uterine weight or liver weights.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Ulceration of the stomach and gas filled intestines were observed in 20 mg a.s./kg bw/d females at gross necropsy.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Description (incidence and severity):
- There were no abortions or early births.
- Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- effects observed, treatment-related
- Description (incidence and severity):
- One dam each at 1 and 10 mg/kg bw/d and two dams at 20 mg/kg bw/d were not pregnant.
- Other effects:
- not specified
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
There were no maternal mortalities. Audible respiration and gasping was observed at 20 mg a.s./kg bw/d. Audible respiration was observed at 10 mg a.s./kg bw/d. Reduced body weight gain and food consumption were observed at 20 mg a.s./kg bw/d. Ulceration of the stomach and gas filled intestines were observed in 20 mg a.s./kg bw/d females at gross necropsy. There were no treatment-related effects on gravid uterine weight or liver weights. There were no abortions or early births.
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 mg/kg bw/day
- Based on:
- act. ingr.
- Basis for effect level:
- clinical signs
- Dose descriptor:
- NOEL
- Effect level:
- 20 mg/kg bw/day
- Based on:
- act. ingr.
- Basis for effect level:
- other: developmental toxicity
Maternal abnormalities
- Key result
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- other: quivalent to ca. 1.2 mg test substance/kg bw/d. Based on clinical signs (audible breathing) observed at 10 mg a.s./kg bw/d
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- There were no treatment-related effects on foetal body weight.
- Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- All pregnant dams had one or more live foetuses at scheduled sacrifice.
- 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
- Description (incidence and severity):
- No malformations were noted at gross necropsy.
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- There were no treatment-related skeletal or visceral variations or malformations.
- Visceral malformations:
- no effects observed
- Description (incidence and severity):
- There were no treatment-related visceral malformations.
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
One dam each at 1 and 10 mg/kg bw/d and two dams at 20 mg/kg bw/d were not pregnant. All pregnant dams had one or more live foetuses at scheduled sacrifice. There were no treatment-related effects on foetal body weight, and no malformations were noted at gross necropsy. There were no treatment-related skeletal or visceral variations or malformations.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 20 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: no developmental toxicity observed at the highest dose level
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
No developmental toxicity including teratogenicity was observed at any dosage employed.
Applicant's summary and conclusion
- Conclusions:
- Maternal toxicity was evident at 10 and 20 mg a.s./kg bw/d. No developmental toxicity including teratogenicity was observed at any dose.
- Executive summary:
The teratogenic potential of the test item was evaluated in female Sprague-Dawley rats according to OECD 414. The test substance was administered by gavage to pregnant rats on gestation days 6 -15, at concentrations of 0, 1, 10 and 20 mg a.s./kg/d. The dams were sacrificed at gestation day 21 and the foetuses were examined for visceral and skeletal variations and malformations.
Pregnant rats treated with 20 mg a.s./kg bw/d showed reduced body weight gain and reduced food consumption. Audible respiration and gasping occurred at 20 mg a.s./kg bw/d and audible breathing also occurred at 10 mg a.s./kg bw/d. Ulceration of the stomach and gas filled intestines were observed at 20 mg a.s./kg bw/d. All other dams and all foetuses remained unaffected. There were no treatment-related effects on foetal body weight or visceral/skeletal findings. The NOAEL for maternal toxicity was 1 mg a.s./kg/day (equivalent to ca. 1.2 mg test substance/kg bw/d); the NOEL for developmental toxicity was at least 20 mg a.s./kg/day (equivalent to ca. 24.8 mg test substance/kg bw/d).
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