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EC number: 939-350-2 | CAS number: 85409-22-9
- 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: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to the OECD guideline 409 as well as in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides
- EC Number:
- 270-325-2
- EC Name:
- Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides
- Cas Number:
- 68424-85-1
- IUPAC Name:
- N-benzyl-N,N-dimethyltetradecan-1-aminium chloride
- Reference substance name:
- Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chloride (i.e., benzyl C12-16 alkyl dimethyl ammonium chloride)
- IUPAC Name:
- Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chloride (i.e., benzyl C12-16 alkyl dimethyl ammonium chloride)
- Details on test material:
- Test substance: ca. 50%
C12-16-benzyldimethylammonium chloride (CAS no.: 68424-85-1)
in water only. Specification as in 1.1-1.4: C12-16 BKC (C12: 72.0%; C14: 27.7%; C16: 0.3%)
(batch No. 667H3002)
Constituent 1
Constituent 2
Test animals
- Species:
- dog
- Strain:
- Beagle
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Continuous
Doses / concentrations
- 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/d (males); 0, 9, 26 and 45 mg/kg/d (females)
Basis:
- 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
Examinations
- 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.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not examined
- Urinalysis 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
- 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/d (males); 0, 9, 26 and 45 mg/kg/d (females).
No clinical signs were attributed to treatment with the test substance. No mortality observed. Body weight: 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: 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.
No treatment-related effects on organ weights were noted. Gross and histopathology showed no findings.
Effect levels
open allclose all
- 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/d, respectively.
- 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/d, respectively.
- Dose descriptor:
- LOAEL
- Effect level:
- >= 50 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the condition of the study, the 90-d NOAEL for systemic effects in Beagle dogs was established at the highest tested dose of 1500 or 1250 ppm active substance in males and females, respectively (i.e., corresponding to 50 or 45 mg a.i./kg bw/d, respectively).
- Executive summary:
A guideline compliant 90 day dietary study in Beagle dogs was conducted at doses of 0, 500, 1,500 and 3,000 ppm (corresponding to 0, 250, 750 or 1,500 ppm of active substance). Four males and 4 females per dose group were used. From Week 8, the concentration of test substance was reduced to 2,500 ppm (1,250 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/kg bw/day (males); 0, 9, 26 and 45 mg/kg bw/day (females). No treatment-related toxicologically significant effect was observed up to the highest tested dose. A mean body weight loss observed in females from the high-dose group (3,000 ppm) 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 2,500 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-day NOAEL for systemic effects in Beagle dogs was established at the highest tested dose of 1,500 or 1,250 ppm active substance in males and females, respectively (i.e., corresponding to 50 or 45 mg a.i./kg bw/day, respectively) (Guilaumat P-O, 2006).
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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