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Diss Factsheets
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EC number: 222-048-3 | CAS number: 3327-22-8
- 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://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 451
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- (3-chloro-2-hydroxypropyl)trimethylammonium chloride
- EC Number:
- 222-048-3
- EC Name:
- (3-chloro-2-hydroxypropyl)trimethylammonium chloride
- Cas Number:
- 3327-22-8
- Molecular formula:
- C6H15ClNO.Cl
- IUPAC Name:
- 3-chloro-2-hydroxy-N,N,N-trimethylpropan-1-aminium chloride
- Details on test material:
- IUCLID4 Test substance: as prescribed by 1.1 - 1.4
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Details on exposure:
- Route of Administration: dermal
- Duration of treatment / exposure:
- 89 weeks females, 105 weeks males
- Frequency of treatment:
- Twice a week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 13.8, 138 mg/animal or approximately 575 mg/kg or 5750 mg/kg per week
Basis:
- Control animals:
- yes
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No data.
BODY WEIGHT AND WEIGHT GAIN and FOOD CONSUMPTION
No treatment related changes in food consumption were noted, but there were occasional statistically significant changes in the high dose males, which consumed more food in weeks 3/4, 10/11, 25/26, and 97/98. During week 49/50, these animals had slightly lower food consumption. The low dose group had slightly lower food consumption in week 65/66. The high dose females had marginally higher food consumption in weeks 3/4, 11/12, 13/14, 65/66 to 73/74. Low dose females had slightly increased food consumption in weeks 3/4, 11/12 and 81/82. The overall food consumption was 3.3% higher in low dose females and 6.6 in high dose females. These changes were considered to reflect biological variation since they were marginal, less than 10 % overall.
No treatment related body weight changes were observed during the study. The body weight of low dose males was slightly higher during weeks 11 to 21 (max. 6.5 %) 57, to 61 (5.0 %) and in the week 73 (6.1 %). The body weight of low and high dose females was slightly higher in week 65 (7.4 % in low and 7.7% in high dose).
OPHTHALMOSCOPIC EXAMINATION;
HAEMATOLOGY;
CLINICAL CHEMISTRY;
URINALYSIS;
NEUROBEHAVIOUR;
ORGAN WEIGHTS
No data
GROSS PATHOLOGY
In the pathological examination, a small but statistically significant decrease of left testis absolute (0.223 g control, 0.214 g low dose (-4%) and 0.192 g high dose (-14%)) and organ weight relative to body weight (0.488 control, 0.477 (-2%) low dose and 0.414 high dose (-15%)) was seen in the high dose male mice. The female mice of the high dose group had an increased absolute and relative weight of the liver and adrenals. The absolute weight of the right kidney was increased in the high dose females.
HISTOPATHOLOGY: NON-NEOPLASTIC
In histopathology, the microscopical examination revealed a slight dose-related increase in the incidence of minimal to mild focal acanthosis and hyperkeratosis at the application site.
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
HISTORICAL CONTROL DATA (if applicable)
OTHER FINDINGS
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 575 other: mg/kg bw/wk
- Dose descriptor:
- LOAEL
- Effect level:
- 5 750 other: mg/kg bw/wk
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
There were no significant treatment related differences between the test substance and control group animals. No treatment related changes in
food consumption were noted, but there were occasional statistically significant changes in the high dose males, which consumed more food in
weeks 3/4, 10/11, 25/26, and 97/98. During week 49/50, these animals had slightly lower food consumption. The low dose group had slightly lower
food consumption in week 65/66. The high dose females had marginally higher food consumption in weeks 3/4, 11/12, 13/14, 65/66 to 73/74. Low
dose females had slightly increased food consumption in weeks 3/4, 11/12 and 81/82. The overall food consumption was 3.3% higher in low dose
females and 6.6 in high dose females. These changes were considered to reflect biological variation since they were marginal, less than 10 %
overall. No treatment related body weight changes were observed during the study. The body weight of low dose males was slightly higher during
weeks 11 to 21 (max. 6.5 %) 57, to 61 (5.0 %) and in the week 73 (6.1 %). The body weight of low and high dose females was slightly higher in
week 65 (7.4 % in low and 7.7% in high dose). In the pathological examination, a small but statistically significant decrease of left testis absolute
(0.223 g control, 0.214 g low dose (-4%) and 0.192 g high dose (-14%)) and organ weight relative to body weight (0.488 control, 0.477 (-2%) low
dose and 0.414 high dose (-15%)) was seen in the high dose male mice. The female mice of the high dose group had an increased absolute
and relative weight of the liver and adrenals. The absolute weight of the right kidney was increased in the high dose females. In histopathology, the
microscopical examination revealed a slight dose-related increase in the incidence of minimal to mild focal acanthosis and hyperkeratosis at the
application site.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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