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Diss Factsheets
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EC number: 947-548-5 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Repeat insult patch testing but In-use study
- Deviations:
- not applicable
- Principles of method if other than guideline:
- One hundred four women participated in an in-use study to determine the safety and efficacy of a shampoo containing 2% Cocamide DEA. Each panelist was patch tested on the upper arm with 2% aqueous shampoo, containnig other typical shampoo ingredients (preservative 15ppm and fragrance 5% in oil). The three occlusive patches were applied and scored for irritation 48 h later at the time of patch removal.
The subjects were then instructed to shampoo daily with the test product for 87 days.
Ten days after the final use of the shampoo, challenge patches were administered following the same procedure as the initial patches except the preservative concentration was increased to 50 ppm
and an additional scoring for reactions was made 24 h after patch removal. No reactions were observed to the preservative or fragrance patches.
Eleven subjects reacted to the 2% shampoo initial patch; eight had mild erythema (l+scores on a O-4 scale), one had intense erythema (2+), and two subjects had erythema and edema (3+). Twenty-four subjects had irritation scores of 1 + (18/24), 2+ (3/24), and 3+ (3/24) 48 h after challenge patch application of the shampoo. Thirty subjects had 1 + (25/30) or 2 + (5/30) irritation scores at the second
challenge reading.
All reactions were considered to be irritant in nature. The shampoo was an irritant but not a sensitizer. - GLP compliance:
- not specified
- Remarks:
- data taken from a CIR review paper. Full details are not disclosed and the test was 1983 so GLP not necessarily required at that time.
- Type of study:
- patch test
- Justification for non-LLNA method:
- Because adequate data from an in vivo skin sensitisation study are available.
Test material
- Reference substance name:
- Amides, coco, N,N-bis(hydroxyethyl)
- EC Number:
- 271-657-0
- EC Name:
- Amides, coco, N,N-bis(hydroxyethyl)
- Cas Number:
- 68603-42-9
- Molecular formula:
- C16H33NO
- IUPAC Name:
- N,N-Bis(2-hydroxyethyl)dodecanamide
Constituent 1
- Specific details on test material used for the study:
- 2% patched as 2% aqueous solution, used full strength for 87 days
In vivo test system
Test animals
- Species:
- other: human
- Sex:
- female
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- other: observations on human use
- Hours after challenge:
- 240
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 11
- Total no. in group:
- 104
- Clinical observations:
- Eleven subjects reacted to the 2% shampoo initial patch; eight had mild erythema (l+ scores on a O-4 scale), one had intense erythema (2+), and two subjects had erythema and edema (3+). All reactions were considered to be irritant in nature
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- On the basis of the animal and clinical data assessed, the CIR Expert Panel concluded that Cocamide DEA is safe as used in rinse-off products and safe at concentrations ~10% in leave-on cosmetic products. Cocamide DEA should not be used as an ingredient in cosmetic products in which N-nitroso compounds are formed.
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