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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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not available
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 83-4 (Reproduction and Fertility Effects)
- 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:
- Badrac 2280
- IUPAC Name:
- Badrac 2280
- Details on test material:
- The test material was Bardac 2280 (Didecyldimethylammonium Chloride; DDAC, in aqueous/alcohol solution), batch number B-1889, obtained from Lonza Inc. The substance was described as a very viscous honey coloured liquid, supplied as 80.8% a.s. in aqueous/ethanol solution.
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
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The test animals were male and female Sprague-Dawley rats (Crl:CD (SD) BR), obtained from Charles River Breeding Laboratories (MI, USA). The animals were acclimatised for approximately 2 weeks. Representative animals were selected for faecal examination, serum viral antibody analysis and histological examination of selected organs. The rats were housed in pairs during quarantine, and singly thereafter (except during cohabitation and lactation) in stainless steel mesh cages. From gestational day 20 through to weening, females were housed in plastic shoebox cages with bedding.
The rats were 6 weeks old at study initiation and weighed 204.2-205.8 g (males) and 153.3-155.2 g (females). Diet (Certified Ground Rodent Chow #5002) and tap water were provided ad libitum. Room temperature and humidity were monitored, and a 12 hour light/dark cycle was maintained.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- The test substance was mixed direcly into the animal diet (fed ad libitum). All weights of the test material were corrected for percent active ingredient for diet preparation, and loss of ethanol during diet preparation was also taken into account. The test diets were stored at room temperature.
- Details on mating procedure:
- Rats were mated one male to one female for 3 weeks.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentration of the test substance in the diet, homogeneity and stability were determined using gas chromatography with Nitrogen-Phosphorous detection. Homogeneity was confirmed, and the test diets were demonstrated to be stable for 21 days when stored in closed polyethylene containers and for at least 14 days when stored in open glass jars at room temperature. Periodic analyses of the test diets indicated that the mean test substance concentrations in the diet for the 300, 750 and 1500 ppm levels were 96.2-108.8%, 98.8-108.8% and 94.5-109.2% of nominal, respectively.
- Duration of treatment / exposure:
- F0: 27 weeks (from 1st prebreed dose to last F0 sacrifice)
F1: 32 weeks (from 1st F1B wean to last F1B sacrifice)
F2B: to weaning - Frequency of treatment:
- Continuous - ad libitum dietary exposure
- Details on study schedule:
- After a 10-week pre-breed period, rats were mated (one male to one female) for three weeks to produce the F1A generation. The observation of a dropped copulation plug or the presence of vaginal sperm was considered evidence of successful mating. Exposures continued through mating, gestation, parturition and lactation. At least 10 days after the weaning of the F1A litters, the F0 parents were paired again to produce the F1B generation. At weaning, 28F1B weanlings/sex/group were selected to produce the F2 generation, and were then exposed to the same dietary concentrations of Didecyldimethylammonium Chloride as their parents for 10 weeks. After their pre-breed exposure, F1 animals were paired as described above to produce F2A and F2B litters.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 300 ppm
- Remarks:
- Basis:
nominal in diet
- Dose / conc.:
- 750 ppm
- Remarks:
- Basis:
nominal in diet
- Dose / conc.:
- 1 500 ppm
- Remarks:
- Basis:
nominal in diet
- No. of animals per sex per dose:
- 28/sex/group
- Control animals:
- yes, plain diet
- Details on study design:
- Initial animals (F0) were randomly assigned to groups using a computer generated stratified body weight programme. Only healthy animals with a body weight ±20% of the mean weight for each sex were included in the study.
- Positive control:
- Not applicable.
Examinations
- Parental animals: Observations and examinations:
- Detailed clinical observations were performed once each week. Observations for overt clinical signs were made twice daily on days when detailed observations were not conducted. Observations for mortality were made twice daily.
Bodyweights were recorded weekly during the pre-beeding period and during mating for both sexes. Bodyweights were recorded for females on gestational day (gd) 0, 6, 15 and 20 and on postnatal day (pnd) 0, 7, 14 and 21.
Food consumption was recorded weekly during the pre-breeding period for both sexes, and for females in 3 or 4 day intervals throughout gestation and to pnd 4. - Oestrous cyclicity (parental animals):
- Not determined.
- Sperm parameters (parental animals):
- Not determined.
- Litter observations:
- All pups were weighed on postnatal day (pnd) 1, 4, 7 and 14, and at weaning (day 21).
- Postmortem examinations (parental animals):
- All F0 and F1 parental animals were necropsied and examined for gross lesions. Reproductive tissues and other tissues with gross lesions identified as potentially related to treatment were harvested. All these tissues from the high dose and control groups and any tissues or organs showing gross alterations from the low and mid dose groups were examined histologically. A complete gross necropsy and histopathologic examination were conducted for any parental animals dying on test.
- Postmortem examinations (offspring):
- Examination for gross lesions was performed on any pup appearing abnormal or dying on test. Ten F1A, F1B and F2 weanlings/sex/group were randomly selected and examined for gross lesions. Remaining nonselected F1 and F2 pups at weaning were euthanised and discarded after the necropsy of the selected pups.
- Statistics:
- The results of the quantitative continuous variables (e.g., body weights, food consumption, etc.) were intercompared for the three treatment groups and one control group by use of Leaven’s test for equal variances, analysis of variance and (pooled or separate variance) t-test. Non-parametric data were statistically evaluated using the Kruskal-Wallis test followed by the Mann-Whitney U test for pairwise comparisons when appropriate. Frequency data were compared using the Fisher’s exact test.
- Reproductive indices:
- Mating index, fertility index, gestational index, live birth index, 4-day survival index, 7-day survival index, 14-day survival index, 21-day survival index, lactation index, 28-day survival index.
- Offspring viability indices:
- See above.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- 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 at 1500 ppm a.s.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- reduced at 1500 ppm a.s.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
No significant signs of toxicity during the pre-breed, mating, gestation or lactation periods at any dose for either generation. There were no mortalities.
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
F0 and F1 10-Week Pre-mating Exposure: No treatment-related effects on body weights were observed at 300 or 750 ppm a.s.. Males and females at 1500 ppm a.s. had reductions in body weight beginning one week after treatment. Body weight gain was also reduced.
F0 and F1 Gestation/Lactation: No treatment-related effects on body weights were observed at 300 or 750 ppm a.s.. Females in the 1500 ppm a.s. group showed significant reductions in body weights but no body weight gain reductions during the first (producing the F1A and F2A litters) breeding period. Body weight but not weight gain was also reduced throughout lactation. During the second breeding (producing the F1B and F2B litters), gestational body weights and weight gains appeared to be lower than control and lactational body weights but not weight gains were reduced.
TEST SUBSTANCE INTAKE (PARENTAL ANIMALS)
F0 and F1 10-Week Pre-mating Exposure: No treatment-related effects on food consumption were observed at 300 or 750 ppm a.s.. Food consumption in males and females was reduced throughout the pre-breed periods for the 1500 ppm a.s. group.
F0 and F1 Gestation/Lactation: Food consumption during gestation and lactation for both breeding periods was unaffected by test substance treatment at any dose.
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
Reproductive parameters were unaffected by treatment for all groups during the first and second breeding of both the F0 and F1 animals.
ORGAN WEIGHTS (PARENTAL ANIMALS)
No treatment-related findings were observed.
GROSS PATHOLOGY (PARENTAL ANIMALS)
No treatment-related findings were observed.
HISTOPATHOLOGY (PARENTAL ANIMALS)
No treatment-related findings were observed.
OTHER FINDINGS (PARENTAL ANIMALS)
No other findings were reported.
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 750 ppm (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to ca. 928 ppm test substance. Based on reduced body weights and food consumption at 1500 ppm a.s.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- reduced at 1500 ppm a.s.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not examined
- Anogenital distance (AGD):
- not examined
- Nipple retention in male pups:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Details on results (F1)
There were no signs of toxicity in the F1A, F1B, F2A or F2B animals.
BODY WEIGHT (OFFSPRING)
No treatment-related effects on body weights were observed at 300 or 750 ppm. F1A litters exhibited reduced body weights and weight gains from pnd 14 through 28 at 1500 ppm. A similar effect was observed for F1B, F2A and F2B pups.
ORGAN WEIGHTS (OFFSPRING)
There were no treatment-related findings in the F1A, F1B, F2A or F2B weanling animals at necropsy.
GROSS PATHOLOGY (OFFSPRING)
There were no treatment-related findings in the F1A, F1B, F2A or F2B weanling animals at necropsy.
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 750 ppm (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to ca. 928 ppm test substance. Based on reduced body weights and food consumption at 1500 ppm a.s.
Results: F2 generation
Effect levels (F2)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 750 ppm (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to ca. 928 ppm test substance. Based on reduced body weights at 1500 ppm a.s.
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 750 ppm
- Treatment related:
- yes
Applicant's summary and conclusion
- Conclusions:
- These results indicate that continuous exposure to test item in the diet for two generations in Sprague-Dawley (CD®) rats resulted in no adverse reproductive effects. Parental toxicity was observed at 1500 ppm, limited to body weight reduction, weight gain depression and decreased food consumption. Postnatal toxicity was observed at 1500 ppm, consisted of reduced pup body weights. The adult effect levels are equivalent to 112.6 mg of test chemical per kg body weight at 1500 ppm. The "no observable effect level" (NOEL) for adults in this study was 750 ppm. The NOEL for offspring in this study was 750 ppm (males: 38 - 79 mg/kg bw/day and females: 49 - 82 mg/kg bw/day), indicating no increased risk to offspring in the absence of maternal effects.
- Executive summary:
The study was carried out in accordance with EPA OPP 83-4. Sprague-Dawley rats were given diets containing Bardac 2280 ( Didecyldimethylammonium Chloride in aqueous/alcohol solution) at concentrations of 0, 300, 750 and 1500 ppm a.s.. A 10-week pre-breed exposure was used for both the F0 and F1 generations. Two litters per generation were produced. Body weights were decreased in males and females at 1500 ppm for most of the pre-breeding exposure period as well as for the F1A, F1B, F2A, and F2B offspring during lactation. Food consumption was also reduced during the pre-breeding periods for both the F0 and F1 parental animals. No other treatment-related effects were observed including on any reproductive parameters. On the basis of these results the NOAEL (parental, F1 offspring and F2 offspring) was considered to be 750 ppm a.s. (equivalent to ca. 928 ppm test substance). It was concluded that the test substance was not toxic to reproduction under the conditions of the study.
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