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EC number: 638-747-5 | CAS number: 1228186-17-1
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study predates official guidelines and GLP but is performed according to former scientific standards and is well documented. Animal species used had been rabbits.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- assessment report
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- in majority mild redness in high dose group
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- The dermal treatment resulted in some slight irritative responses mainly in high dose animals. No clinical or morphological sign of substance-induced systemic toxicity.
- Dose descriptor:
- NOAEL
- Effect level:
- 40 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: based on systemic effects ( NOAEC = 2% )
- Dose descriptor:
- NOAEL
- Effect level:
- 4 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: based on local skin effects ( NOAEC = 0.2% )
- Critical effects observed:
- not specified
- Conclusions:
- Based on the results of this study, the NOAEL for systemic effects was 40 mg/kg body weight per day (or 2% v/v) and the NOAEL for local skin effects was 4 mg/kg body weight per day (or 0.2 % v/v).
- Executive summary:
The study used as source investigated repeated dermal toxicity.The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- 20 dermal applications to rabbits (one per day, 5 days per week, 4 weeks) of 2 mL per kg body weight of 0, 0.2 and 2% aqueous test substance solution
- GLP compliance:
- no
- Remarks:
- study predates GLP
- Limit test:
- no
Test material
- Reference substance name:
- Dihydrogenatedtallowalkyldimethylammonium chloride
- IUPAC Name:
- Dihydrogenatedtallowalkyldimethylammonium chloride
- Details on test material:
- - Name of test material (as cited in study report): Präpagen WK
- Physical state: pasty
- Analytical purity: 75 % active in isopropanol/water
- Impurities (identity and concentrations): < 2% tertiary amine
- Composition of test material, percentage of components: 75% active, isopropanol, water
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: 1976
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stable
- Storage condition of test material: darkness at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Gelbsilber
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 2.24 +/- 0.24 kg
- Fasting period before study: no
- Housing: single in metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24°C (medium temperature)
- Humidity (%): 60% (medium relative humidity)
- Air changes (per hr): approximately 12
- Photoperiod (hrs dark / hrs light): 12 hours periodically
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on exposure:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100
- Time intervals for shavings or clipplings: one day prior to start of treatment, thereafter once weekly
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL
- Concentration (if solution): 0, 0.2, 2% (v/v)
- Constant volume or concentration used: yes
- For solids, paste formed: yes/no
VEHICLE
- Justification for use and choice of vehicle (if other than water): water
USE OF RESTRAINERS FOR PREVENTING INGESTION: no - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 20 dermal applications (5 per week for 4 weeks)
- Frequency of treatment:
- single treatment per day
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 %
Basis:
nominal per unit body weight
- Remarks:
- Doses / Concentrations:
0.2 %
Basis:
nominal per unit body weight
- Remarks:
- Doses / Concentrations:
2 %
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 3 male and 3 female rabbits per group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: expert judgement
- Rationale for animal assignment (if not random): random
- Rationale for selecting satellite groups: no satellite groups
- Post-exposure recovery period in satellite groups: n.a.
- Section schedule rationale (if not random): random - Positive control:
- not required
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily each working day
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily each workin day
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: daily each workin day
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION:
- Food consumption: Yes (continuously)
WATER CONSUMPTION: Yes
- Time schedule for examinations: daily each workin day
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: weekly
- Dose groups that were examined: all groups
HAEMATOLOGY: Yes
- Time schedule for collection of blood: prior to start of study and after study termination
- Anaesthetic used for blood collection: No
- Animals fasted: No data
- How many animals: all animals
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at termination of study
- Animals fasted: No data
- How many animals: all animals
URINALYSIS: Yes / No / No data
- Time schedule for collection of urine:
- Metabolism cages used for collection of urine: Yes / No / No data
- Animals fasted: Yes / No / No data
- Parameters checked in table [No.?] were examined.
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: prior to start of study and after termination
- Dose groups that were examined: all dose groups
- Battery of functions tested: no data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- in majority mild redness in high dose group
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- The dermal treatment resulted in some slight irritative responses mainly in high dose animals. No clinical or morphological sign of substance-induced systemic toxicity.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 40 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: based on systemic effects ( NOAEC = 2% )
- Dose descriptor:
- NOAEL
- Effect level:
- 4 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: based on local skin effects ( NOAEC = 0.2% )
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study, the NOAEL for systemic effects was 40 mg/kg body weight per day (or 2% v/v) and the NOAEL for local skin effects was 4 mg/kg body weight per day (or 0.2 % v/v).
- Executive summary:
Technical grade dihydrogenatedtallowalkyldimethylammonium chloride (DHTDMAC; "Präpagen WK") containing approximately 77% in isopropanol/water was tested in a dermal repeated dose study in rabbits. The study predated official test guidelines and GLP but is of sufficient quality to give some information on the potential systemic toxicity of DHTDMAC via the dermal route of exposure.Groups of 3 male and 3 female rabbits (strain "Gelbsilber") received 20 dermal applications (5 days per week for 4 consecutive weeks) of aqueous solutions containing 0, 0.2 and 2% DHTDMAC (corresponding to about 0, 4 and 40 mg/kg body weight per day). General behaviour, general health condition, food consumption were not influenced by the treatment. Additionally no neurological disturbances, tooth cognition or ophthalmologic investigations of the cornea showed no findings. Haematology, clinical chemistry and urinalysis revealed no significant findings. Gross pathology of the animals at study termination as well as histopathological investigations of heart, lung, liver, spleen, adrenals, testes and ovaries, pituitary gland, and thyroids revealed no substance related changes. Local skin effects in form of slight redness and foldings were observed in some of the high dose animals. Based on the results of this study the NOAEL for systemic dermal effects was greater 2% (v/v) aqueous DHTDMAC solution or greater 40 mg/kg body weight per day.
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