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EC number: 263-196-9 | CAS number: 61791-64-8
- 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
Endpoint summary
Administrative data
Description of key information
Dermal route: Systemic effects attributable to the irritant nature of the test material were reported in two out of three available studies involving dermal application at doses up to 800 mg/kg bw/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Remarks:
- date of study not specified
- Remarks on result:
- other: Systemic effects attributable to the irritant nature of the test material were reported in two out of three available studies involving dermal application at doses up to 800 mg/kg bw/day.
- Critical effects observed:
- no
- Conclusions:
- Systemic effects attributable to the irritant nature of the test material were reported in two out of three available studies involving dermal application at doses up to 800 mg/kg bw/day.
- Executive summary:
Study 1
A shaving cream containing 1.92% cocamide DEA was applied to the intact or abraded skin on the back of 8 New Zealand White (NZW) rabbits. Applications of 500 mg/kg of the test product were made 5x/wk for 4 wks. Dermal irritation was observed at both intact and abraded application sites. No systemic effects attributed to dosing were observed.
Study 2
The repeated-dose dermal toxicity of cocamide DEA (containing 18.2% free diethanolamine by wt) was evaluated using mice. Groups of 10 male and 10 female B6C3F1 mice were dosed with 50, 100, 200, 400, or 800 mg/kg bw cocamide DEA in ethanol (20-320 mg/mL), for 5 exposures/wk, for 14 wks. Vehicle only was applied to the negative control group. All animals survived until study termination. Dermal irritation was observed at the application sites of males and females of the 800 mg/kg dose group. Epidermal and sebaceous gland hyperplasia, parakeratosis, chronic active inflammation, and ulceration were observed; severity generally increased with increased dose. Final mean body weights and mean body weight gains were similar for test and control animals. The absolute liver and kidney weights and relative liver and kidney weights to body weights of males and females of the 800 mg/kg group, relative liver weights to body weights of females of the 400 mg/kg group, and absolute lung weights and relative lung weights to body weights of females of the 800 mg/kg group were significantly greater than for those of the controls. The epididymal spermatozoal concentration was significantly greater in males of the 800 mg/kg dose group.
Study 3
Groups of 20 male and 20 female F344/N rats were dosed dermally with 25, 50, 100, 200, or 400 mg/kg/bw cocamide DEA in ethanol (30-485 mg/ml), 5 exposures/wk, for 14 weeks; 10 rats per group were used for clinical chemistry and hematology evaluation. Vehicle only was applied to the negative control group. All animals survived until study termination. Dermal irritation was observed at the application sites of 2 males and one female of the 100 mg/kg group and in nearly all males and females of the 200 and 400 mg/kg dose groups. Lesions included epidermal and sebaceous gland hyperplasia, parakeratosis, chronic active inflammation, and ulceration; incidence and severity generally increased with increasing dose. Final mean body weights and mean body weight gains of males and females of the 200 and 400 mg groups were significantly less than those of the controls. Kidney weights of females of the 50 mg/kg group were significantly greater than those of the controls. Decreases in epididymal weights in 200 and 400 mg/kg males were attributed to decreased body weights. Changes in some hematology and clinical chemistry parameters were noted and the researchers stated there was an indication of altered lipid metabolism, as evidenced by decreased cholesterol and triglyceride concentrations. The incidences of renal tubule regeneration were greater in females of the 100 dose group, and the incidences and severities were greater in females of the 200 and 400 mg/kg dose groups, as compared to controls.
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- See read-across justification attached in Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Remarks on result:
- other: Systemic effects attributable to the irritant nature of the test material were reported in two out of three available studies involving dermal application at doses up to 800 mg/kg bw/day.
- Critical effects observed:
- no
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Available studies involving the dermal administration of an analogue substance (EC 271-657-0] report effects that are considered to be caused by the irritant nature of the test material. Classification for systemic toxicity under the terms ofRegulation (EC) No. 1272/2008 is therefore not appropriate.
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