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EC number: 226-901-0 | CAS number: 5538-94-3
- 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:
- 3rd March 1987 - 17th March 1987
- 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:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- - Principle of test: to assess the short term toxicity of a test article in rabbits when administered by the dermal route.
- Short description of test conditions: The animals were acclimitised for 5 days prior to treatment. The fur from the dorsal area of the trunk of the test animals was clipped on the day of treatment. The substance was applied uniformly over the clipped area and held in contact with the skin for a 24 hour exposure period using gauze. Residual substance will be removed following the the exposure period using water (if possible).
- Parameters analysed / observed: Bodyweight, mortality, toxic effects, cage side effects (skin, fur, eyes, mucous membranes, respiratory, circulatory automic and central nervous system, somato-motor activity and behaviour patterns). Upon necropsy gross pathology examinations. - GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Dimethyldioctylammonium chloride
- EC Number:
- 226-901-0
- EC Name:
- Dimethyldioctylammonium chloride
- Cas Number:
- 5538-94-3
- Molecular formula:
- C18H40NCl
- IUPAC Name:
- dimethyldioctylazanium chloride
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor provided the substance.
STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Final dilution of a dissolved solid, stock liquid or gel: The volume of liquid product administered to each animal was adjusted based on the stated 80% activity of the material to achieve the speific treatment level.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gota-Frisco Farms, Edon, OH (USA)
- Females (if applicable) nulliparous and non-pregnant:not specified
- Weight at study initiation: 2.704 to 2.745 kg
- Housing: Housed individually in suspended stainless steel cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- ethanol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal area of the trunk
- % coverage: 10% of the animal's total body surface.
- Type of wrap if used: A layer of 8 ply gauze dressing, a lyer of rubber dam and several wrappings of 3 inch Elastoplast tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water.
- Time after start of exposure: 24 hours after treatment.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.06, 0.2, 0.42 or 0.83 ml/kg bw
- Concentration (if solution): 8, 160, 336 or 664 mg/kg bw
- Constant volume or concentration used: not specified
- Duration of exposure:
- 24 hours.
- Doses:
- 8, 160, 336 or 664 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- yes, concurrent vehicle
- Remarks:
- 10% v/v denat. ethanol in water
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed for mortality and toxic effects for 8 hours after dosing and daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, gross pathology.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 259 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 82 - <= 639
- Mortality:
- No deaths occurred in the vehicle control animals and in the 8 mg/kg bw group (lowest dose).
In the 160 mg/kkg bw group 4 out of 10 animals had died.
In the 336 mg/kkg bw group 6 out of 10 animals had died.
In the 664 mg/kkg bw group 7 out of 10 animals had died. - Clinical signs:
- other: The substance produced significant dermal irritation in the animals which was characterised by eschar formation at the treatment site. In all animals, eschar formation was evident by the day following dose administration. A dose-response related incidence
- Gross pathology:
- There were a number of gross pathologic findings reported throughout both the test and control groups with no apparent dose-response relationship. The findings in the dead animals could be an artefact of post-mortem changes, such as increased incidence of colour changes in kidneys and lungs. There was a single animal with white material in the lungs from a treatment group, this was atributed to pulmonary infection in this rabbit. Cardiac anomalies was noted in several animals from the treatment groups with no apparent dose-response relationship.
Any other information on results incl. tables
Treatment | Dose | No. of Deaths/No. Dosed | ||
Males | Females | Sexes Combined | ||
10% Ethanol/Water | 5.6 ml/kg bw | 0/5 | 0/5 | 0/10 |
Substance | 8 mg/kg bw | 0/5 | 0/5 | 0/10 |
160 mg/kg bw | 2/5 | 2/5 | 4/10 | |
336 mg/kg bw | 3/5 | 3/5 | 6/10 | |
664 mg/kg bw | 4/5 | 3/5 | 7/10 |
Clinical Finding(s) | Incidence of Finding in Treatment Groups | ||||
Vehicle Control | 8 mg/kg bw | 160 mg/kg bw | 336 mg/kg bw | 664 mg/kg bw | |
Soft stools and/or faecal stain | 1/10 | - | - | 1/10 | 1/10 |
Few faeces | 1/10 | 4/10 | 6/10 | 8/10 | 4/10 |
Laboured breathing | - | - | - | 1/10 | 2/10 |
Prostration | - | - | - | - | 1/10 |
Nasal discharge | - | 1/10 | - | - | - |
Activity decreased | - | 1/10 | 2/10 | 3/10 | 5/10 |
Tremors | - | - | - | - | 2/10 |
Ataxia | - | - | - | 1/10 | - |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The dermal LD50 in rabbits is 259 mg/kg bw. Based on the observations the substance is considered to be corrosive to the skin and toxic by the dermal route as established by the LD50.
- Executive summary:
In an acute dermal toxicity study an 80% solution of the substance was administered to rabbits (5 animals/sex/dose) by dermal administration at dose levels of 8, 160, 336 or 664 mg/kg bw (single administration) for a duration of 24 hours. A number of animals died in the top 3 dose groups and clinical toxicity was observed in the treatment animals, this included significant dermal irritation characterised by eschar formation at the treatment site. In all animals, eschar formation was evident by the day following dose administration. A dose-response related incidence of clinical effects included reduced faeces, laboured breathing and decreased activity. Prostration, nasal discharge, tremors and ataxia was observed in the top dose only. Mean body weights in the top 3 dose groups was reduced, but generally a partial or complete recovery of body weights was observed in the majority of animals that survived to termination. The dermal LD50 in rabbits is 259 mg/kg bw.
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