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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-2 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- DDAC
- IUPAC Name:
- DDAC
- Reference substance name:
- 1-Decanaminium, N-decyl-N,N-dimethyl-, chloride
- IUPAC Name:
- 1-Decanaminium, N-decyl-N,N-dimethyl-, chloride
- 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
- Details on test material:
- The test substance was described as a yellow liquid. Storage at room temperature. The test substance is hydrolytically and photolytically stable under the study conditions and has been shown to be stable in aqueous alcohol and alcohol/aqueous solutions for extended periods, e.g. at least 7 years under standard laboratory conditions.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The test animals were male and female New Zealand White young adult rabbits, obtained from Gota-Frisco Farms, Ohio. The animals were housed individually in suspended stainless steel cages in an environmentally controlled room with a 12 hour light/dark cycle. Feed (Agway Prolab Rabbit Ration) and fresh water were provided ad libitum. The rabbits were allowed to acclimatise to the laboratory conditions for at least 5 days. Only healthy animals were selected for the study. The rabbits weighed 2.245-3.09 kg (males) and 2.195-2.956 kg (females) at study initiation.
In-life dates were 3 to 17 March, 1987.
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- other: 10% v/v ethanol and water
- Details on dermal exposure:
- The test substance (in vehicle: 10% v/v ethanol in water) was applied dermally to the rabbits. The volume of liquid administered to each animal was adjusted based on the 80% content of the active ingredient, to achieve the specified treatment level. The vehicle was prepared fresh prior to dosing.
On the day prior to dosing, the fur was clipped from the dorsal area of the trunk of each rabbit using small animal clippers. The exposed area on each animal measured approximately 12 x 20 cm (approximately 10% of the animal's total body surface). The following day, the test substance was applied uniformly over the exposed skin. An occlusive binder (8 ply gauze dressing, a layer of rubber dam and several wrappings of 3 inch Elastoplast tape) was secured around the trunk of the animal immediately after treatment. The dressing was removed after 24 hours and residual test material was wiped from the skin using clean gauze and distilled water. - Duration of exposure:
- 24 hours
- Doses:
- Doses were prepared taking into account the purity of the test substance (80%): 0, 552, 1104, 3328 and 4448 mg a.s./kg bw, corresponding to dose volumes 0.69, 1.38, 4.16 and 5.56 ml/kg, respectively. 5.56 ml/kg bw of the vehicle (10% v/v ethanol and water) was applied to the controls.
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Healthy animals were allocated to treatment groups randomly. The exposure period was 24 hours, and the observation period was 15 days. The rabbits were observed daily for clinical signs and mortality. Bodyweights were recorded on Days 1, 8 and 15. Gross necropsy was performed on animals that died during the study and those that survived to study termination.
- Statistics:
- Probit Analysis (Finney, 1997) was used in LD50 calculations.
Results and discussion
- Preliminary study:
- Not applicable.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5.56 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Actual dose administered, assuming a density of 1
- Mortality:
- No mortalities occurred at concentrations below 3328 mg a.s./kg bw. 3/5 males and 2/5 females died at a concentration of 3328 mg a.s./kg bw and 5/5 males and 3/5 females died at a concentration of 4448 mg a.s./kg bw.
- Clinical signs:
- other: No clinical signs were observed in 552 mg/kg bw group. The most common observations at 1104 mg/kg bw and above was reduced faeces, ocurring within 72 hours of dosing and persisting for 1-4 days. Additional observations in one 1104 mg/kg bw animal included
- Gross pathology:
- Necropsy findings were minimal. At a dose rate of 4448 mg a.s./kg the test substance caused a pale cortex of the kidneys in 4/10 animals and a distention of the atrium and/or ventricles in 3/10 animals. One animal in the 3328 mg/kg bw group had a heavily pigmented gel in the large intestines.
- Other findings:
- The test substance caused eschar formation in all animals at all doses at the treatment site within 24 hours.
Any other information on results incl. tables
Table 1. Mortality data
|
|
|
Study day |
|
||||||||||||||
Sex |
Test subs. conc. (mg a.s./kg bw) |
No. Animals |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
Total |
M |
552 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1104 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3328 |
5 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
3 |
|
4448 |
5 |
0 |
0 |
0 |
1 |
3 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
5 |
F |
552 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1104 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3328 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
2 |
|
4448 |
5 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Table 2. Clinical Signs
Clinical Signs |
Test substance concentration (mg a.s./kg bw) |
||||
0 |
552 |
1104 |
3328 |
4448 |
|
Soft stools and/or faecal stain |
1/10 |
0/10 |
1/10 |
5/10 |
1/10 |
Few faeces |
1/10 |
3/10 |
9/10 |
10/10 |
10/10 |
Laboured breathing |
0/10 |
0/10 |
0/10 |
1/10 |
4/10 |
Prostration |
0/10 |
0/10 |
0/10 |
4/10 |
2/10 |
Convulsions |
0/10 |
0/10 |
0/10 |
0/10 |
1/10 |
Thrashing in cage |
0/10 |
0/10 |
0/10 |
0/10 |
1/10 |
Rales |
0/10 |
0/10 |
0/10 |
0/10 |
1/10 |
Nasal discharge |
0/10 |
0/10 |
2/10 |
1/10 |
1/10 |
Activity decreased |
0/10 |
0/10 |
1/10 |
10/10 |
10/10 |
Tremors |
0/10 |
0/10 |
0/10 |
1/10 |
3/10 |
Ataxia |
0/10 |
0/10 |
0/10 |
1/10 |
3/10 |
Emaciated |
0/10 |
0/10 |
0/10 |
7/10 |
5/10 |
Dark material around mouth |
0/10 |
0/10 |
1/10 |
2/10 |
1/10 |
Urine stain |
0/10 |
0/10 |
0/10 |
2/10 |
1/10 |
Mucoid material in litter pan |
0/10 |
0/10 |
2/10 |
3/10 |
0/10 |
Table 3. Mean body weight data (kg)
|
|
Study day |
|
|
Sex |
Test substance concentration (mg a.s./kg) |
1 |
8 |
15 |
Male |
552 |
2.832 |
2.806 |
2.988 |
|
1104 |
2.667 |
2.431 |
2.606 |
|
3328 |
2.730 |
1.868 |
2.057 |
|
4448 |
2.770 |
n/d |
n/d |
Female |
552 |
2.641 |
2.575 |
2.415 |
|
1104 |
2.502 |
2.222 |
2.415 |
|
3328 |
2.583 |
1.819 |
1.818 |
|
4448 |
2.678 |
1.894 |
1.905 |
n/d no data (all animals were dead)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 (both sexes) was calculated as 3342 mg/kg bw (5.56 mL/kg bw test substance, assuming a density of 1)
- Executive summary:
The acute dermal toxicity of DMD10AC (80% Didecyldimethylammonium Chloride) was evaluated in male and female New Zealand White rabbits. The test substance was applied dermally to the skin of the rabbits for 24 hours, at the following concentrations: 0, 552, 1104, 3328 and 4448 mg/kg bw. The rabbits were observed for 15 days post-exposure for clinical signs of toxicity, mortality and bodyweight changes. Gross necropsy was performed on survivors at study termination and on rabbits that died during the study.
The test substance caused skin irritation at the dose site in all animals. 5 rabbits died at a concentration of 3328 mg/kg bw and 8 rabbits died at a concentration of 4448 mg/kg bw. There was a dose-related reduction in body weight. At a dose rate of 4448 mg/kg bw the test substance caused a pale cortex of the kidneys in 4/10 animals and a distention of the atrium and/or ventricles in 3/10 animals. The LD50 (both sexes) was calculated as 3342 mg/kg bw (equivalent to 5.56 mL/kg bw test substance, assuming a density of 1) with confidence limits 0 - 4293 mg/kg bw, and therefore no classification is required.
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