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Diss Factsheets
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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
Oral route: Published data report the LD50 of an analogue substance to be > 5 g/kg following oral administration.
Dermal route : The acute dermal toxicity of cocamide DEA was evaluated using albino rabbits. Cocamide DEA were applied to intact and abraded skin for 24 h using occlusive patches. None of the animals died, and the LD50 was >2 g/kg.
Cocamide DEA is a mixture of ethanolamides of coconut acid. The chemistry of the amides is considered to be sufficiently close to the cocamines to be a suitable surrogate for read-across in the absence of any animal test data for the substance under registration.
Other similar cocamide species, such as lauramide DEA, were also tested in this acute dermal toxicity study and also found to be non-toxic
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Remarks:
- date of studies not specified
- Species:
- rat
- Route of administration:
- oral: unspecified
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 5 other: g/kg
- Based on:
- test mat.
- Clinical signs:
- other:
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Published data report the LD50 of an analogue substance to be > 5 g/kg following oral administration.
- Executive summary:
Results from three studies involving an analogue substance are available. In the first study, an acute oral toxicity test in male and female Sprague-Dawley rats, undiluted cocamide DEA had an LD50 of 12.2 g/kg. In the second study, the acute oral toxicity of cocamide DEA was determined using groups of 3 male and 3 female Wistar rats. Three or more animals per group died with doses of ≥ 6.3 g/kg. In the third study, LD50 of cocamide DEA was reported as > 5 g/kg or 5 mL/kg, which was the highest dose tested.
- Endpoint:
- acute toxicity: oral
- 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
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 other: g/kg
- Based on:
- test mat.
- Clinical signs:
- other:
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- 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:
- OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
- Version / remarks:
- Assumed from details given in the review. Actual method used was not quoted
- GLP compliance:
- not specified
- Remarks:
- No details given in the review article
- Test type:
- fixed dose procedure
- Species:
- rabbit
- Strain:
- other: Albino
- Sex:
- male/female
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Applied to intact and abraided skin
- Duration of exposure:
- 24 hours
- Doses:
- 2g/kg
- No. of animals per sex per dose:
- 3
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other:
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal toxicity of cocamide DEA was evaluated using albino rabbits. Cocamide DEA were applied to intact and abraded skin for 24 h using occlusive patches. None of the animals died, and the LD50 was >2 g/kg.
Cocamide DEA is a mixture of ethanolamides of coconut acid. The chemistry of the amides is considered to be sufficiently close to the cocamines to be a suitable surrogate for read-across in the absence of any animal test data for the substance under registration.
Other similar cocamide species, such as lauramide DEA, were also tested in this acute dermal toxicity study and also found to be non-toxic - Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Clinical signs:
- other:
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Oral route: Results from three studies involving an analogue substance are available. In the first study, an acute oral toxicity test in male and female Sprague-Dawley rats, undiluted cocamide DEA had an LD50 of 12.2 g/kg. In the second study, the acute oral toxicity of cocamide DEA was determined using groups of 3 male and 3 female Wistar rats. Three or more animals per group died with doses of ≥ 6.3 g/kg. In the third study, LD50 of cocamide DEA was reported as > 5 g/kg or 5 mL/kg, which was the highest dose tested.
Inhalation route: Investigation of acute toxicity via the inhalation route is not required because the substance is a solid with predicted high onset boiling point and low predicted vapour pressure. It is therefore expected that inhalation exposure from identified uses performed under industrial conditions will be negligible.
Dermal route: The registered substance has been shown to be irritating to skin and, in the interests of animal welfare, investigation of systemic toxicity via the dermal route is contraindicated.
Justification for classification or non-classification
An analogue substance exhibits low acute toxicity via the oral route (LD50 > 5g/kg). Based on these data, classification of the target substance for acute toxicity is not required under the terms of Regulation (EC) No 1272/2008.
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.