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EC number: 629-705-7 | CAS number: 1228186-15-9
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2009-12-17 to 2010-02-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, chlorides
- EC Number:
- 263-082-9
- EC Name:
- Quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, chlorides
- Cas Number:
- 61789-73-9
- IUPAC Name:
- 61789-73-9
- Reference substance name:
- Quaternary ammoniums compounds, benzylbis (hydrogenated tallow alkyl) methyl, chlorides
- IUPAC Name:
- Quaternary ammoniums compounds, benzylbis (hydrogenated tallow alkyl) methyl, chlorides
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Approximately 10 weeks old
- Weight at study initiation: Males: 388 ± 9 g and Females: 263 ± 12 g
- Fasting period before study: Not applicable
- Housing: The rats were housed individually in polycarbonate cages with stainless steel lid
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: At least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): Approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light
IN-LIFE DATES: From: 17 December 2009 To: 10 February 2010
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal area
- % coverage: 10% of the total body surface of the animals
- Type of wrap if used: Hydrophilic gauze pad held in contact with skin by an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage. The gauze pad was moistened with 2 mL purified water prior to applying the test material
REMOVAL OF TEST SUBSTANCE
- Washing : No
-Time after start of exposure: 24 hours after application, the dressing was removed and any residual test item was removed using a dry cotton pad.
TEST MATERIAL
- Amount(s) applied : 200, 1000 and 2000 mg/kg bw
- Concentration (if solution): Not applicable, the test material was a paste.
- Constant volume or concentration used: yes. Constant concentration - dose volume adjusted for bodyweight on day of treatment - Duration of exposure:
- 24 hours
- Doses:
- 200, 1000 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex at 2000 mg/kg bw, 1 female at 1000 mg/kg bw and 1 female at 200 mg/kg bw
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed after dose administration at least once during the first 30 minutes, periodically during the first 24 hours, then daily for a period of 14 days. Dermal reactions were scored using a standard Draize assessment. Bodyweights were recorded at weekly intervals from Day 1.
- Necropsy of survivors performed: yes - Statistics:
- none
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was reported at any of the tested dose levels.
- Clinical signs:
- other: No clinical signs were reported except some local dermal reactions observed in all dose groups (see other findings).
- Gross pathology:
- No macroscopic changes were noted at necropsy.
- Other findings:
- Local reactions such as erythema and oedema were reported during the course of the study.
At the dose-levels of 200 and 1000 mg/kg bw, well-defined to severe erythema, scabs, dryness and discoloration area (greenish, brownish or blackish) and/or oedema were observed with a similar severity.
Local reactions (erythema, dryness, oedema, discoloration area and scabs) observed at 2000 mg/kg bw were similar in severity to those recorded at 1000 mg/kg bw.
Any other information on results incl. tables
In the first step, no mortality and systemic clinical signs were noted in the one female treated at the dose-level of 200 mg/kg bw and in the other one treated at the dose-level of 1000 mg/kg bw. The local reactions were observed with a similar severity whatever the dose. According to these results, a highest dose-level of 2000 mg/kg bw was tested in one female and then confirmed in four additionnal females and five males.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP (Reg. 1272/2008/EC) and Directive 67/548/EEC
- Conclusions:
- Under the experimental conditions of this study and according to the criteria laid down in CLP (Reg 1272/2008/EC) and directive 67/548/EEC, the test material (Quaternary ammoniums compounds, benzylbis (hydrogenated tallow alkyl) methyl, chlorides ) is not classified.
- Executive summary:
The objective of this study was to evaluate the toxicity of the substance following a single dermal application to rats according to the OECD guideline 402 and to the EU Method B.3. The study was conducted in compliance with the principles of Good Laboratory Practice regulations.
The test item in its original form was applied to the skin of Sprague-Dawley rats. The treated area was then covered by a semi-occlusive dressing for 24 hours. In first instance, the test item was administered sequentially at dose-levels of 200, 1000 then 2000 mg/kg to one female per dose-level, in order to evaluate the potential toxicity and local tolerance of the test item. According to the results obtained at each dose-level, a highest dose-level was tested or the dose-level was confirmed in four other females and tested in five males.
Mortality and clinical signs were checked daily for a period of 14 days following the single application of the test item. Body weight was recorded on days 1, 8 and 15. At the end of the 14-day observation period all animals were sacrificed and subjected to necropsy.
In the first step, at the dose-level of 200 and 1000 mg/kg, no mortality and systemic clinical signs were noted. The local reactions, as erythema (well-defined to severe), scabs, dryness and discoloration area (greenish, brownish or blackish) and/or oedema were observed with a similar severity.
According to these results, a highest dose-level of 2000 mg/kg was tested in one other female and then confirmed in four additionnal females and five males.No deaths and no relevant systemic clinical signs were observed during the study at the dose-level of 2000 mg/kg. Local reactions (erythema, dryness, edema, discoloration area and scabs) observed at 2000 mg/kg were similar in severity to those recorded at 1000 mg/kg. The body weight was not affected by the test item treatment. No abnormalities were observed at macroscopic examination.
Under these experimental conditions, the dermal LD0 of the test substance was higher than or equal to 2000 mg/kg in rats.
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