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EC number: 204-527-9 | CAS number: 122-19-0
- 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: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
Reference
- Endpoint:
- appearance / physical state / colour
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From December 06, 2017 to December 06, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.6302 (Color)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.6303 (Physical State)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.6304 (Odor)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Identity: Benzyldimethyl(octadecyl)ammonium chloride
Batch no: 14217
Content: Cationic activity 97.6%
Expiry date: 06/2019
Storage conditions: Room temperature, protect from humidity and water - Physical state at 20°C and 1013 hPa:
- solid
- Key result
- Form:
- solid
- Colour:
- White
- Odour:
- sweetish
- Substance type:
- organic
- Conclusions:
- Under the study conditions, the test substance is a white solid with sweetish odour at ambient temperature.
- Executive summary:
A study was conducted to determine the physical state, color and odour of the test substance, C18 ADBAC (active: 97.6%), according to the OCSPP Guidelines 830.6302, 830.6303 and 830.6304, in compliance with GLP. Under the study conditions, the test substance is a white solid with sweetish odour at ambient temperature (Wannenwetsch, 2017).
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Vapour pressure:
- 0 Pa
- at the temperature of:
- 25 °C
The vapour pressure of the test substance was determined using the static method, according to EU Method A.4, (Chilworth, 2017) as well using three QSAR i.e., EPI Suite v.4.11, US EPA T.E.S.T (US EPA, 2018) and ChemProp (UFZ, 2018).
In absence of a reliable experimental study with the test substance, the vapour pressure (VP) endpoint has been assessed based on the below weight of evidence:
- Experimental VP = 6.6 Pa at 20 °C; the measured VP value is considered to be reliable with restrictions, as it can be suspected to be influenced by trapped gas/solvent/impurities.
- Estimated VP = 1.59E-11 Pa at 25°C (using modified grain method of EPI Suite v.4.11 program); 7.38E-7 at 25°C (using consensus method of T.E.S.T. v.4.2.1); the estimates are considered to be reliable with restrictions, as they do not completely fall within of the applicability domain. Also, the two QSAR models are not powered enough to predict ionic substances. Therefore the VP was estimated using a third QSAR model, ChemProp v.6.0, which resulted in VP values 5.75E-5 Pa and 1.12E-7 Pa at 25°C using modified Grain Antoine and modified Grain Watson methods respectively.
- Experimental VP of structurally similar substance, C12-16 ADBAC: 1.5E-03 Pa at 20°C and 1.58E-3 Pa at 25°C (ECHA REACH dossier; EC: 939-253-5).
Overall, based on the available weight of evidence, the test substance can be considered to have low volatility. However, in absence of a reliable experimental value, the higher QSAR based VP value (i.e., 5.75E-5 Pa) at25°C has been considered further for hazard/risk assessment.
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- KL2 due to RA
- Justification for type of information:
- Refer to the section 13 of IUCLID dataset for details on the read across justification. The algae study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- dog
- Strain:
- Beagle
- Sex:
- male/female
- Route of administration:
- oral: feed
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Continuous
- Remarks:
- Doses / Concentrations:
0, 500, 1500 and 3000 ppm of test substance in the diet. The mean achieved dosages of active substance, based on food consumption and body weight information were as follows: 0, 8, 25 and 50 mg/kg bw/day (males); 0, 9, 26 and 45 mg/kg bw/day (females). - No. of animals per sex per dose:
- 4 males and 4 females per dose group
- Control animals:
- yes, plain diet
- Details on study design:
- Post-exposure period: none
- Observations and examinations performed and frequency:
- Observations included: Clinical signs, mortality, body weight, food consumption, Ophthalmology, haematology, clinical chemistry and urinanalysis.
- Sacrifice and pathology:
- Pathology of all animals (organ weight, gross pathology) and histopathology on the control and high dose animals.
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical signs were attributed to treatment with the test substance.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- No treatment related effects on the body weight gain were attributed to the test substance. A mean body weight loss was noted in females from the high-dose group when given 3000 ppm of test substance. This body weight loss was not dose-related and correlated to the decrease of food consumption recorded among the females of that dose group. When the dosing was reduced to 2500 ppm of test substance, a mean body weight gain, similar to that noted in the control females was recorded. Consequently, this effect was associated with the low appetency of the diet at this dose-level.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- In the 500 and 1500 ppm dose group, the food consumption was unaffected in males and females. A markedly lower (-27%) food consumption was noted in females at the high dose group of 3000 ppm. After reduction of the dose-level to 2500 ppm test substance, the food consumption was only slightly lower (-6%). No effects seen at ophthalmoscopic examination, haematology, clinical chemistry and urine analysis.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- From week 8, the concentration of test substance was reduced to 2500 ppm (equivalent to 1250 ppm of active substance) in the high-dose female group, due to low food intake. The mean achieved dosages of active substance, based on food consumption and body weight information were as follows: 0, 8, 25 and 50 mg/kg bw/day (males); 0, 9, 26 and 45 mg/kg bw/day (females).
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male
- Basis for effect level:
- other: No toxicologically significant effect; 1500 ppm (male) and 1250 ppm (female) were corresponding to 50 and 45 mg a.i./kg/ bwday, respectively.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 45 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- female
- Basis for effect level:
- other: No toxicologically significant effect; 1500 ppm (male) and 1250 ppm (female) were corresponding to 50 and 45 mg a.i./kg bw/day, respectively.
- Key result
- Critical effects observed:
- no
- Conclusions:
- Based on the results of the study, the 90 d NOAEL for systemic effects in Beagle dogs is considered to be at the highest tested dose of 1500 or 1250 ppm a.i. in males and females, respectively (i.e., corresponding to 50 and 45 mg a.i./kg bw/d, respectively)
- Executive summary:
A 90-d study was conducted to determine the repeated dose oral toxicity of the read across substance, C12-16 ADBAC (active: 50%) in Beagle dogs, according to OECD Guideline 409, in compliance with GLP. In this study, the test substance was administered to 4 animals per sex per group at dietary concentrations of 0, 500, 1500 and 3000 ppm (equivalent to 0, 250, 750 or 1500 ppm a.i.). From Week 8, the concentration of test substance was reduced to 2500 ppm (1250 ppm of active substance) in the high dose female group due to low food intake. The mean achieved dosage of active substance, based on food consumption and body weight, were 0, 8, 25 and 50 mg a.i./kg bw/d for males and 0, 9, 26 and 45 mg a.i./kg bw/d for females. No treatment-related toxicologically significant effects were observed up to the highest tested dose. A mean body weight loss observed in females from the high dose group was not dose-related and correlated to the decrease of food consumption recorded among the females of that dose group. When the dosing was reduced to 2500 ppm of test substance, a mean body weight gain, similar to that noted in the control females, was recorded. Consequently, this effect was associated with the reduced palatability of the diet at this dose level. Under the conditions of the study, the 90 d NOAEL for systemic effects in Beagle dogs was considered to be at the highest tested dose of 1500 or 1250 ppm a.i. in males and females, respectively (i.e., corresponding to 50 and 45 mg a.i./kg bw/d, respectively) (Guillaumat, 2006). Based on the results of the read across study, similar NOAEL for systemic effects can be considered for the test substance, C18 ADBAC, in 90-d repeated dose oral toxicity in dogs.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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