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EC number: 271-653-9 | CAS number: 68603-38-3 This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl carboxylic acid amide diethanol and SDA Reporting Number: 11-024-00.
- 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 available data suggests that amides, C16-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl) has a low potential for acute oral (LD50 >3,000 mg/kg bw) and dermal toxicity (LD50 >2,000 mg/kg bw, based on a study tested with read across substance, C8-18 and C18- unsatd., N,N-bis(hydroxyethyl).
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
- Study period:
- From December 12, 1989 to February 14, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD 401 guideline study, but not in compliance with GLP.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Bor:WISW (SPF Cpb)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, 4799 Borchen, Germany
- Weight at study initiation: 249 g
- Fasting period before study: > 16 h
- Housing: Groups of up to five by sex in solid-floor polypropylene cages
- Diet: R10 Alleindiät for rats, Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: 5-8 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 60 +/- 5%
- Air changes (per h): 15
- Photoperiod (h dark/h light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 3.09 cm3/kg
- Doses:
- 3,000 mg/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 d
- Frequency of clinical observation: Continuously up to 6 h post-treatment and subsequently once daily for 14 d
- Frequency of weighing: Pre-treatment , then on Days 1, 7 and 14
- Necropsy of survivors performed: Yes
- Examinations performed: Clinical signs, body weight and gross pathological examination - Preliminary study:
- No deaths or clinical signs of toxicity were observed
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 000 mg/kg bw
- Mortality:
- No mortality
- Clinical signs:
- other: All animals were in resting position 30 minutes after dosing. Three had slightly rough fur. Thirty minutes later, no symptoms were seen anymore.
- Gross pathology:
- Six animals showed local thickenings of the mucous membrane of the forestomach; in three of these animals, the mucous membrane of the stomach was slightly reddened.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the study conditions, the LD50 of the test susbtance in rat was found to be > 3,000 mg/kg bw. Hence, it does not warrant a classification according to EU CLP.
- Executive summary:
A study was performed to assess the acute oral toxicity of amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) in Bor:WISW rat according to OECD Guideline 401.
A group of 20 fasted animals (10 males and 10 females) was administered a single oral dose of undiluted test substance at 3,000 mg/kg bw. The animals were observed for 14 d and were then sacrificed and subjected to gross pathological examination.
There were no mortalities. Transient signs of toxicity were observed 30 minutes after dosing, but no longer after that time point. Upon necropsy, thickening of the mucous membrane of the forestomach and slight reddening of the mucous membrane of the stomach was seen in some animals.
Under the study conditions, the LD50 of the test susbtance in rat was found to be > 3,000 mg/kg bw. Hence, it does not warrant a classification according to EU CLP.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 000 mg/kg bw
- Quality of whole database:
- The study was conducted according to OECD 401 guideline study, but not in compliance with GLP.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read across study hence maximum reliability rating of 2 assigned according to ECHA guidance, although study is acceptable, well-documented and meets basic scientific principles.
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- other: A modification of the techniques described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration.
- Deviations:
- not specified
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Test type:
- other: LD50 limit test
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.9 to 2.7 kg
No further information available. - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Type of wrap if used: The trunk of each animal was encased in a sleeve of plasticized material after application of test material
- Duration of exposure:
- 24 h
- Doses:
- 2,000 mg/kg bw
- No. of animals per sex per dose:
- Three animals with abraded skin and three animals with intact skin
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Duration of observation period following administration: Animals were observed immediately after dosing, and at 1, 6 and 24 h post-dosing. Following the 24 h exposure period, animals were observed for mortality, skin response and general behavior for 14 d
- Statistics:
- Not reported
- Preliminary study:
- Not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortalities observed
- Clinical signs:
- other: All animals appeared normal throughout the 24 h exposure period and the 14 d post-exposure observation period.
- Gross pathology:
- Not applicable
- Other findings:
- None
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the acute dermal LD50 of structurally similar 'amides, C8-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl)' was found to be > 2,000 mg/kg bw in albino rabbits, indicating a low toxicity.
- Executive summary:
A study was conducted to determine the acute dermal toxicity of structurally similar 'amides, C8-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl)' in male/female albino rabbit.
The procedure was the modification of the techniques described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration.
2 g/kg bw of test material was applied (single application) to the abraded and intact skin of the test animals. The trunk of each animal was then encased in a sleeve of plasticized material to ensure contact of the test material for a 24 h period. Animals were observed immediately after dosing, and at 1, 6 and 24 h post-dosing. Following the 24 h exposure period, animals were observed for mortality, skin response and general behavior for 14 d.
No mortality was observed in this study. All animals appeared normal throughout the 24 h exposure period and the 14 d post-exposure observation period.
Under the test conditions, the acute dermal LD50 of 'amides, C8-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl)' was found to be > 2,000 mg/kg bw in albino rabbits indicating a low toxicity.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The KL2 rated read across study was well-documented and meets the basic scientific principles.
Additional information
Oral
A study was performed to assess the acute oral toxicity of amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) in Bor: WISW rat according to OECD guideline 401. A group of 20 fasted animals (10 males and 10 females) were administered a single oral dose of undiluted test substance at 3,000 mg/kg bw. The animals were observed for 14 days and were then sacrificed and subjected to gross pathological examination. There were no mortalities. Transient signs of toxicity were observed 30 minutes after dosing, but no longer after that time point. Upon necropsy, thickening of the mucous membrane of the forestomach and slight reddening of the mucous membrane of the stomach was seen in some animals. Under the study conditions, the LD50was > 3,000 mg/kg bw (Mürmann P, 1990).
Dermal
A single application of 2,000 mg/kg bw of structurally similar amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl) applied to the abraded and intact skin of the test animals resulted in no mortality. All animals appeared normal throughout the 24 hour exposure period and during the 14 day post-exposure observation period. The dermal LD50was determined to be >2,000 mg/kg bw, which indicates a low acute dermal toxicity (Palanker AL, 1976) . Amides, C16-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl) is therefore also expected to have low acute dermal toxicity.
Inhalation
The test substance has a very low vapor pressure, so the potential for the generation of inhalable forms is low. Also, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, therefore exposure to humans via the inhalatory route is unlikely to occur under the conditions of normal and foreseeable handling and use.
Justification for selection of acute toxicity – oral endpoint
Only one relevant guideline compliant study was available.
Justification for selection of acute toxicity – inhalation endpoint
The test substance has very low vapor pressure, so the potential for the generation of inhalable forms is low, also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route is unlikely to occur under the conditions of normal and foreseeable handling and use.
Justification for selection of acute toxicity – dermal endpoint
Only one relevant RA study was available.
Justification for classification or non-classification
The available data indicates a low potential for acute toxicity (oral and dermal LD50of >3,000 and >2,000 mg/kg bw respectively) and does not meet the requirement for classification according to according to EC criteria (67/548/EEC) and according to CLP criteria (EC 1272/2008).
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