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Diss Factsheets
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EC number: 205-560-1 | CAS number: 142-78-9
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
NOAEL (systemic toxicity) = >= 1000 mg/kg bw/day (no hazard identified); OECD 422 (Anon., 2018)
In a study conducted in accordance with OECD 422, three groups of 10 male and 10 female rats received N-(2-hydroxyethyl) dodecanamide at the doses of 100, 350 and 1000 mg/kg/day. No test-item-related mortality was observed during the study, and administration of N-(2-hydroxyethyl) dodecanamide at 100, 350 or 1000 mg/kg/day was considered not to have any relevant effects on clinical condition, body weight, food consumption, grip strength, sensory reactivity and motor activity, pre-coital interval, mating performance and fertility, or gestation length. Salivation was recorded in all test-item-administered groups; the incidence was dose-related in both sexes and is most likely due to taste aversion (from gavage dosing). Estrous cycles before and during treatment were considered not to be altered by the test item. At termination, all reproductive phase females showed diestrus. In males administered at 1000 mg/kg/day, hematocrit, hemoglobin and lymphocytes were affected with respect to Control. Although it cannot be considered an adverse effect as the males’ physiology was not affected, and it was not possible to positively attribute the finding to the test item. There were no differences in coagulation, clinical biochemistry or organ weights considered treatment-related. T4 analyses of samples in F0 males and F1 offspring on day 13 did not reveal any differences that could be attributable to treatment. There were no macroscopic findings that could be considered test-item-related. Histopathology revealed that there were no treatment-related effects in any of the examined organs or in the reproductive organs or mammary glands. There were no adverse effects observed in the offspring. So, offspring survival, litter size, clinical signs, body weights, ano-genital distances or macropathology were not affected by N-(2-hydroxyethyl) dodecanamide administration.
The No Observed Adverse Effect Level (NOAEL) for systemic toxicity was considered to be >= 1000 mg/kg/day for males and the NOEL was >= 1000 mg/kg bw/day for females.
The hazard conclusion for reproductive and developmental toxicology were as follows (OECD 422, Anon., 2018):
NOAEL(fertility) = >= 1000 mg/kg bw/day (no hazard identified)
NOAEL(development) = >= 1000 mg/kg bw/day (no hazard identified)
The results are based on the observations of no effects on estrous cycle, pre-coital interval, mating performance, fertility and gestation length or in the offspring on litter size, survival, sex ratio, clinical signs, body weights, ano-genital distances or macropathology.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
In accordance with Annex VIII, Section 8.5.2, Column 2 of REACH, testing by the inhalation route was waived due to low vapour pressure and a use pattern resulting in exposure to humans being considered negligible. No acute toxicity hazard (leading to classification & labelling) has been identified for the substance following oral and dermal exposure. No acute inhalation hazard is therefore identified for this substance.
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
NOAEL (systemic toxicity) = >= 1000 mg/kg bw/day (no hazard identified); OECD 422 (Anon., 2018)
In a study conducted in accordance with OECD 422, three groups of 10 male and 10 female rats received N-(2-hydroxyethyl) dodecanamide at the doses of 100, 350 and 1000 mg/kg/day. No test-item-related mortality was observed during the study, and administration of N-(2-hydroxyethyl) dodecanamide at 100, 350 or 1000 mg/kg/day was considered not to have any relevant effects on clinical condition, body weight, food consumption, grip strength, sensory reactivity and motor activity, pre-coital interval, mating performance and fertility, or gestation length. Salivation was recorded in all test-item-administered groups; the incidence was dose-related in both sexes and is most likely due to taste aversion (from gavage dosing). Estrous cycles before and during treatment were considered not to be altered by the test item. At termination, all reproductive phase females showed diestrus. In males administered at 1000 mg/kg/day, hematocrit, hemoglobin and lymphocytes were affected with respect to Control. Although it cannot be considered an adverse effect as the males’ physiology was not affected, and it was not possible to positively attribute the finding to the test item. There were no differences in coagulation, clinical biochemistry or organ weights considered treatment-related. T4 analyses of samples in F0 males and F1 offspring on day 13 did not reveal any differences that could be attributable to treatment. There were no macroscopic findings that could be considered test-item-related. Histopathology revealed that there were no treatment-related effects in any of the examined organs or in the reproductive organs or mammary glands. There were no adverse effects observed in the offspring. So, offspring survival, litter size, clinical signs, body weights, ano-genital distances or macropathology were not affected by N‑(2-hydroxyethyl) dodecanamide administration.
The No Observed Adverse Effect Level (NOAEL) for systemic toxicity was considered to be >= 1000 mg/kg/day for males and the NOEL was >= 1000 mg/kg bw/day for females.
The hazard conclusion for reproductive and developmental toxicology were as follows (OECD 422, Anon., 2018):
NOAEL(fertility) = >= 1000 mg/kg bw/day (no hazard identified)
NOAEL(development) = >= 1000 mg/kg bw/day (no hazard identified)
The results are based on the observations of no effects on estrous cycle, pre-coital interval, mating performance, fertility and gestation length or in the offspring on litter size, survival, sex ratio, clinical signs, body weights, ano-genital distances or macropathology.
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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