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Diss Factsheets
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EC number: 939-682-8 | CAS number: -
- 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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
- Type of study / information:
- Identification of substances with significant skin irritation potential with the human 4 hour patch test.
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Assessment of skin irritation potential with the human 4 hour patch test.
- GLP compliance:
- not specified
Test material
- Details on test material:
- - Name of test material (as cited in study report): N,N-dimethyl-N-dodecyl aminobetaine
- Analytical purity: 20% solution
Constituent 1
Method
- Ethical approval:
- confirmed, but no further information available
- Details on study design:
- The human 4 hour closed patch test was designed as part of a strategy to replace the use of animals for the identification of skin irritation/corrosion. the method was considered to be a relevant (and superior) alternative to the rabbit Draize test since the same target organ, living skin, and the same toxic effect, irritation, was measured using the same parameters. The duration of application was chosen to reflect half a normal working shift.
The patch test procedure involved application of 0.2 ml (0.2 g for solid test materials) in a 25 mm Plain Hill Top Chamber containing a Webril pad (moistened for solid test materials) to the skin of the upper outer arm of 30 volunteers for up to 4 hours. To avoid unacceptably high reactions, test materials were applied progressively from 15 and 30 min through 1, 2, 3 and 4 hours. Treatment sites were assessed for the presence of irritation using a four point scale at 24, 48 and 72 hours after patch removal. A volunteer with a "weakly positive" (characterised by mild erythema or dryness across most of the treatment site) or greater reaction at any of the readings was considered to have demonstrated a positive irritant reaction, and treatment with the causative substance did not proceed on that person.
As human skin responses to irritants show a wide interindividual variation, an irritation standard (20 % SDS) was included to assess skin iritation potential in relation to a positive control. The interpretation of results in terms of EC classification was done by statistical comparison of the data with the concurrent SDS control using Fisher's exact test (Fisher, 1935, as modified by Mehta and Patel, 1983). The minimum level of SDS classified as R38 to skin (20 %) was adopted as an appropriate pointer to this threshold in terms of the intensity and frequency of an irritant response in human skin (York et al., 1996). It was concluded that substances which when tested undiluted elicit statistically less skin irritation than this threshold should not be classified R38, whilst those that produce a similar or higher level should be classified as R38.
Inter-ethnic variations had been excluded by preliminary work on SDS demonstrating that these effects were relatively minor.
The results of the study support earlier conclusions of York et al. (1996) that the method provides an accurate 'gold standard' assessment of acute irritation potential to human skin, and in case that the human result differs from the rabbit, the human result should be considered as the correct one. - Exposure assessment:
- measured
- Details on exposure:
- TYPE OF EXPOSURE: Closed patch in 25 mm Plain Hill Top Chambers (Hill Top Companies, Cincinatti, OH, USA), containing a Webril pad moistened with the test substance
TYPE OF EXPOSURE MEASUREMENT: other: application of defined amount of test substance
EXPOSURE LEVELS: 0.2 ml of a 20 % solution
EXPOSURE PERIOD: 4 hours, chosen on the same basis as that used by Draize, to be half of a normal working shift.
POSTEXPOSURE PERIOD: 72 hours
DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: 30 human volunteers
Results and discussion
- Results:
- When tested at a concentration of 20 % the test substance elicited positive patch test results in 30/32 individuals (equivalent to 94 %). The corresponding positive control (20 % SDS) demonstrated positive patch test results in 27/32 individuals (equivalent to 84 %).
Therefore, the test substance at a concentration of 20 % should be classifed as irritating to the skin (R38), which is in accordance with the existing EC classification based on animal testing.
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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