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EC number: 612-396-8 | CAS number: 61791-19-3
- 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
Carcinogenicity
Administrative data
Description of key information
The absence of neoplastic lesions or carcinogenic activity in two 2-yr chronic bioassays in rodents suggests that the structural homologue tested (please refer to ch. 13 for justification) and consequently the target substance is not considered to have carcinogenic potential.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Exceeds the information requirements for this tonnage band.
Justification for classification or non-classification
The absence of neoplastic lesions or carcinogenic activity in chronic bioassay in rodents suggests that amides, C18 -unsatd., N, N-bis(hydroxyethyl) is not considered to have carcinogenic potential. Therefore based on the overall weight of evidence, amides C18 -unsatd., N, N-bis(hydroxyethyl), does not require classification for the carcinogenicity endpoint according to EC criteria (67/548/EEC) and CLP criteria (EC 1272/2008).
Additional information
Two year chronic dermal studies (NTP report 481, 1999) have been conducted with the close homologue oleic acid diethanolamine condensate (ODEA) in rats and mice and have been thouroughly investigated as part of the US National Toxicology Programme (NTP).
F344/N rats were administered doses of 0, 50, or 100 mg/kg bw/d of the test substance to 50 male and female test animals in each group. Five exposures per week were given for 104 weeks.The mean body weights of males and females (week 24 onwards) were reduced than those of the vehicle control group at 100 mg/kg bw/day. Dose dependent increase in irritation (i.e., mild to moderate) and non-neoplastic lesions (i.e., minimal to moderate) of the skin was observed at the site of application in males and females. The non-neoplastic lesions included epidermal hyperplasia, sebaceous gland hyperplasia, hyperkeratosis, parakeratosis, chronic active dermal inflammation, and ulcer. No significant neoplastic lesions or evidence of carcinogenic activity was observed at any tested dose levels in skin, testis and thyroid gland.
Under the test conditions, no evidence of carcinogenic activity was observed with the test substance at any tested dose levels in rats. The NOAEL for systemic effects and the LOAEL for local effects can be considered to be at 50 mg/kg bw/d respectively.
B6C3F1 micewere administered doses of 0, 15 or 30 mg/kg bw/d to 50 male/female test animals in each group. 5 exposures per week were given for 105 weeks.5 males and 5 females were considered for the 3-month interim evaluation mice. The mean body weights of females (week 76 onwards) were reduced than those of the vehicle control group at 30 mg/kg bw/day. The only significant treatment related clinical finding was irritation of the skin at the site of application in 30 mg/kg bw/day males. The incidences of epidermal hyperplasia, sebaceous gland hyperplasia, and chronic active inflammation of the dermis in all dosed groups were significantly increased relative to the vehicle controls at 3 months and at 2 years. The increased incidences of hyperkeratosis in dosed males at 3 months and in dosed males and females at 2 years, of parakeratosis in 30 mg/kg bw/day males at 3 months and 2 years, and of ulcer in 30 mg/kg bw/day males and exudate in 30 mg/kg bw/day males and females at 2 years were also attributed to the test substance administration. No significant neoplastic lesions or evidence of carcinogenic activity was observed at any tested dose levels in skin and lymph nodes. Under the test conditions, no evidence of carcinogenic activity was observed with the test substance at any tested dose levels in mice. The NOAEL for systemic and local effects can be considered to be at 15 mg/kg bw/d respectively (NTP 481 report, 1999).
Justification for selection of carcinogenicity via dermal route endpoint:
2 year dermal rat study conducted by NTP and appropriate to base the assessment on.
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.
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