Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
The CIR review in 1986 of four cosmetic ingredients (Cocamide DEA, Lauramide DEA, Linoleamide DEA, and Oleamide DEA) concluded that 'generally, these products were mild skin irritants but not sensitizers or photosensitizers.'
Further assessment of cocamide DEA was carried out by the same panel in 1996 (Journul of the American College of Toxicology
15(6):527-542, 1996 Cosmetic Ingredient Review). Clarification of the original conclusion is based on the results of a skin irritation test in which 15 volunteers were tested with a surfactant solution containing 10% Cocamide DEA, the highest concentration tested in predictive patch tests.
On the basis of the animal and clinical data presented in the present report, the 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 (Amides, coco, N,N-bis(hydroxyethyl) is the ethanol derivative rather than the propionate equivalent, which is the substance under review. It is essentially the same structural formula with an ethyl group instead of a propyl group and as such is assessed as being a good surrogate substance for read-across in the absence of actual oral toxicity data on the substance itself.)
It is not thought necessary to advise that further testing should be carried out since the level at which this substance is used in commercially available products (shampoos etc) is ca. 3%, well below the 10% that the CIR panel advused as being the safe limit.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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.
- Specific details on test material used for the study:
- 2% patched as 2% aqueous solution, used full strength for 87 days
- Species:
- other: human
- Sex:
- female
- 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
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
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.