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EC number: 205-352-0 | CAS number: 139-08-2
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 06, 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A study was conducted to determine the short term repeated dose dermal toxicity of the test substance following application of 1 mL/kg bw (i.e., equivalent to 0.8 mg/kg bw/day) and 4 mL/kg bw (i.e., equivalent to 3.2 mg/kg bw/day) of the test solution in rabbits for 20 days.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Miristalkonium chloride
- EC Number:
- 205-352-0
- EC Name:
- Miristalkonium chloride
- Cas Number:
- 139-08-2
- Molecular formula:
- C23H42N.Cl
- IUPAC Name:
- N-benzyl-N,N-dimethyltetradecan-1-aminium chloride
- Reference substance name:
- Dimethyl(tetradecyl)amine
- EC Number:
- 204-002-4
- EC Name:
- Dimethyl(tetradecyl)amine
- Cas Number:
- 112-75-4
- Molecular formula:
- C16H35N
- IUPAC Name:
- n,n-dimethyltetradecan-1-amine
- Reference substance name:
- N,N-Dimethyltetradecan-1-amine--hydrogen chloride (1/1)
- Cas Number:
- 2016-47-9
- Molecular formula:
- C16H36ClN
- IUPAC Name:
- N,N-Dimethyltetradecan-1-amine--hydrogen chloride (1/1)
- Test material form:
- solid
- Remarks:
- Powder
Constituent 1
impurity 1
impurity 2
- Specific details on test material used for the study:
- 8 oz jar containing a white powder
Lot no.: 263-S
Test substance: Myristyl dimethyl benzyl ammonium chloride
Purity: 99.1%
Dilution of 800 ppm in water was made, based on a 100% active material and used in test
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on exposure:
- TEST SITE
- Area of exposure: Backs and flanks
- % coverage: 10% of total body area
- Type of wrap if used: Rubberized fabric
- Time intervals for shavings or clipplings: Hair was clipped from their backs and flanks. One half of each test area was abraded as required, while the remainder was left intact
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing
- Time after start of exposure: 27 days
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 mL/kg (0.8 mg/kg bw/day) and 4 mL/kg (3.2 mg/kg bw/day)
- Constant volume or concentration used: Yes - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Dose groups:
1 mL/kg = 0.8 mg/kg bw/day
4 mL/kg = 3.2 mg/kg bw/day - Duration of treatment / exposure:
- 20 d
- Frequency of treatment:
- once a day
- No. of animals per sex per dose:
- 1 animal per sex per dose
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- Food, fluid intake, excretions, behavior and appearance of the animals were observed daily. The animals were weighed, as required. Blood and urine studies were performed at the beginning of the test, at the 20 d interval end prior to autopsy.
- Sacrifice and pathology:
- At autopsy, gross findings were made and tissues retained for histological examination.
Results and discussion
Results of examinations
- Clinical signs:
- not examined
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- Minimal erythema was observed in the treated rabbits on day 5, with minimal edema evident on day 9 in the animals receiving the larger dose. In the same group the erythema became more pronounced on day 11, and persisted with minimal edema at those levels through the rest of the treatment interval. At the lower dose level (1 mL/kg bw) minimal hyperemia showed occasional correction with no edema. On day 15 in the same group hyperemia increased slightly in intensity, but became minimal on day 19 and remained that way to day 21. Minimal edema was observed in the 1 mL/kg bw animals on day 17 through the end of treatment. In the control rabbits minimal hyperemia was observed in the rabbits from day 11 through day 21. All rabbits showed complete recovery of dermal irritation within 4 days after cessation of treatment.
- Mortality:
- not examined
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Weights increases were normal.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Food intake was all within normal parameters at all times.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Description (incidence and severity):
- Water intake was all within normal parameters at all times.
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Hematology studies were all within normal parameters at all times.
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Description (incidence and severity):
- Urine analysis studies were all within normal parameters at all times.
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- At no time did any of the rabbits manifest abnormal behavior or appearance.
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Gross findings at autopsy were not significant.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- The histological findings in the treated rabbits were identical to those in the controls.
- Histopathological findings: neoplastic:
- not examined
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- Sysmetic toxicity
- Effect level:
- ca. 3.2 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: non-neoplastic
- urinalysis
- water consumption and compound intake
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 0.8 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- dermal irritation
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 0.8 mg/kg bw/day
- System:
- integumentary
- Organ:
- skin
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Any other information on results incl. tables
Table 1: Histopathology results
Rabbit |
Dose 800 ppm |
Findings |
1 F |
1 mL/kg |
As in control |
2 M |
1 mL/kg |
As in control |
3 F |
4 mL/kg |
As in control |
4 M |
4 mL/kg |
As in control |
5 F |
4 mL/kg |
Water control |
6M |
4 mL/kg |
Water control |
Dose groups:
1 mL/kg = 0.8 mg/kg bw/day
4 mL/kg = 3.2 mg/kg bw/day
Table 2: Dermal reactions 24 h after each set of applications
Day of treatment |
|
1F |
2M |
3F |
4M |
5F* |
6M* |
2 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
|
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
|
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
|
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
Erythema |
0 |
0 |
0 |
1 |
0 |
0 |
|
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
Erythema |
1 |
0 |
1 |
1 |
0 |
0 |
|
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
7 |
Erythema |
1 |
0 |
1 |
1 |
0 |
0 |
|
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
8 |
Erythema |
1 |
1 |
1 |
1 |
0 |
0 |
|
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
9 |
Erythema |
1 |
1 |
1 |
1 |
0 |
0 |
|
Edema |
0 |
0 |
0 |
1 |
0 |
0 |
10 |
Erythema |
0 |
1 |
2 |
2 |
0 |
0 |
|
Edema |
0 |
0 |
0 |
1 |
0 |
0 |
11 |
Erythema |
1 |
1 |
2 |
2 |
1 |
1 |
|
Edema |
0 |
0 |
0 |
1 |
0 |
0 |
12 |
Erythema |
0 |
0 |
2 |
2 |
1 |
1 |
|
Edema |
0 |
0 |
1 |
1 |
0 |
0 |
13 |
Erythema |
0 |
0 |
2 |
2 |
1 |
1 |
|
Edema |
0 |
0 |
1 |
1 |
0 |
0 |
14 |
Erythema |
0 |
0 |
2 |
2 |
0 |
1 |
|
Edema |
0 |
0 |
1 |
1 |
0 |
0 |
15 |
Erythema |
0 |
0 |
2 |
2 |
0 |
1 |
|
Edema |
0 |
0 |
1 |
1 |
0 |
0 |
16 |
Erythema |
0 |
0 |
2 |
2 |
0 |
1 |
|
Edema |
0 |
0 |
1 |
1 |
0 |
0 |
17 |
Erythema |
0 |
0 |
2 |
2 |
0 |
1 |
|
Edema |
0 |
0 |
1 |
1 |
0 |
0 |
18 |
Erythema |
0 |
0 |
2 |
2 |
0 |
1 |
|
Edema |
0 |
0 |
1 |
1 |
0 |
0 |
19 |
Erythema |
1 |
1 |
2 |
2 |
0 |
1 |
|
Edema |
1 |
1 |
1 |
1 |
0 |
0 |
20 |
Erythema |
1 |
1 |
2 |
2 |
1 |
1 |
|
Edema |
1 |
1 |
1 |
1 |
0 |
0 |
21 |
Erythema |
1 |
1 |
2 |
2 |
1 |
1 |
|
Edema |
1 |
1 |
1 |
1 |
0 |
0 |
Applicant's summary and conclusion
- Conclusions:
- Under study conditions, NOAEL for systemic effects and LOAEL for dermal irritation (local effect) were considered to be 3.2 mg/kg bw/day and 0.8 mg/kg bw/day respectively.
- Executive summary:
A study was conducted to determine the short term repeated dose dermal toxicity of the test substance, C14 ADBAC (Purity 99.1%), according to the procedure described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, published by the Association of Food and Drug Officials of the United States. In the study, 1 mL/kg bw (i.e., equivalent to 0.8 mg/kg bw/day) and 4 mL/kg bw (i.e., equivalent to 3.2 mg/kg bw/day) of the 800 PPM solution of the test substance were applied over 10% of the total body surface (Hair clipped back and flank) of the rabbits (one rabbit per sex per dose level) for 20 days. After each application of test substance the torsos of the test animals were wrapped with a rubberized fabric to prevent grooming by the rabbits with possible inhalation or ingestion of test product. Survivors were maintained for two weeks after the last application when all animals were autopsied, as required by the reference. Food, fluid intake, excretions, behaviour and appearance of the animals were observed daily. The animals were weighed, as required. Blood and urine studies were performed at the beginning of the test, at the 20 d interval end prior to autopsy. At autopsy, gross findings were made and tissues retained for histological examination. At no time did any of the rabbits manifest abnormal behaviour or appearance. Food and water intake, excretions, blood and urine studies were all within normal parameters at all times. Weights increases were normal. Minimal erythema was observed in the treated rabbits on day 5, with minimal edema evident on day 9 in the animals receiving the larger dose. In the same group the erythema became more pronounced on day 11, and persisted with minimal edema at those levels through the rest of the treatment interval. At the lower dose level (1 mL/kg bw = 0.8 mg/kg bw/day) minimal hyperemia showed occasional correction with no edema. On Day 15 in the same group hyperemia increased slightly in intensity, but became minimal on Day 19 and remained that way to Day 21. Minimal edema was observed in the 1 mL/kg bw animals on Day 17 through the end of treatment. In the control rabbits minimal hyperemia was observed in the rabbits from day 11 through Day 21. All rabbits showed complete recovery of dermal irritation within 4 d after cessation of treatment. Gross findings at autopsy were not significant. The histological findings in the treated rabbits were identical to those in the controls. Under study conditions, NOAEL for systemic effects and LOAEL for dermal irritation (local effect) were considered to be 3.2 and 0.8 mg/kg bw/day respectively (Luy and Frances, 1972).
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