Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 431-540-9 | CAS number: 170573-32-7
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
- Principles of method if other than guideline:
- The test substance was applied daily to the skin in graduated doses to several groups of mice, one dose per group, for a period of 14 wk. During the period of application the animals were observed daily to detect signs of toxicity. Animals which die during the test were necropsied, and at the conclusion of the test the surviving animals were sacrificed and necropsied.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl)
- EC Number:
- 268-935-9
- EC Name:
- Amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl)
- Cas Number:
- 68603-42-9
- IUPAC Name:
- 268-935-9
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): Coconut oil acid diethanolamine condensate
- Physical state: Viscous yellow liquid
- Composition of test material, percentage of components: Composed primarily of diethanolamides of coconut oil acids, with unreacted diethanolamine, alkanolamides of unsaturated acids, and amine salts of the acids. The polar nitrosamine, N-nitrosodiethanolamine, was detected at a concentration of 219 ppb
- Lot/batch No.: 1G01742286
- Stability: Instable when stored in glass tubes for 2 wk at 60°C
- Storage condition of test material: At room temperature, protected from light, in amber glass bottles sealed with Teflon- lined caps
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test animals:
- Source: Taconic Farms, Germantown, NY
- Age at study initiation: 6 wk
- Housing: Housed individually in Polycarbonate cages (Lab Products, Inc., Maywood, NJ)
- Bedding: Sani-Chip heat-treated hardwood chips (P.J. Murphy Forest Products Corp., Montville, NJ)
- Diet : NIH-07 open formula pelleted diet (Zeigler Brothers, Inc., Gardners, PA), ad libitum
- Water : Tap water (Columbus municipal supply), ad libitum
- Acclimation period: 16 to 17 d
Environmental conditions:
- Temperature : 20.6 -22.8 °C
- Humidity : 41-58 %
- Air changes : 10/hr
- Photoperiod : 12 h dark/12 h light
In-life dates: From: Feb. 12, 1992 - To: May 15, 1992
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- ethanol
- Details on exposure:
- The test material formulations were applied on shaved skin of the test animals.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Periodic analyses of the dose formulations of test material were conducted at the study laboratory using HPLC. Dose formulations from the beginning, middle, and end of the studies were analyzed
- Duration of treatment / exposure:
- 14 weeks
- Frequency of treatment:
- 5 exposures/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 25 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Dose / conc.:
- 400 mg/kg bw/day (nominal)
- Dose / conc.:
- 800 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10/sex/dose group
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Weekly once
BODY WEIGHT: Yes
- Time schedule for examinations: Weighed initially, weekly, and at the end of the studies
OTHER: Organs weighed were heart, right kidney, liver, lung, right testis, and thymus - Sacrifice and pathology:
- SACRIFICE: Yes (Carbon dioxide asphyxiation)
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes. Complete histopathology was performed on 0 and 800 mg/kg bw mice. In addition to gross lesions and tissue masses, the following tissues were examined: adrenal gland, bone and marrow, brain, clitoral gland, esophagus, gallbladder, heart, large intestine (cecum, colon, rectum), small intestine (duodenum, jejunum, ileum), kidney, liver, lung, lymph nodes (mandibular and mesenteric), mammary gland, nose, ovary, pancreas, parathyroid gland, pituitary gland, preputial gland, prostate gland, salivary gland, spleen, stomach (forestomach and glandular), testis (and epididymis and seminal vesicle), thymus, thyroid gland, trachea, urinary bladder, and uterus. - Other examinations:
- Sperm motility and vaginal cytology: At the end of the studies, samples were collected for sperm motility or vaginal cytology from mice of 200, 400 and 800 mg/kg bw groups. The following sperm motility parameters were evaluated: spermatid heads per gram of testis, spermatid heads per testis, spermatid count, and epididymal spermatozoal motility and concentration. The left cauda epididymis, epididymis, and testis were weighed. Vaginal samples for cytology evaluations were collected for 12 consecutive days prior to the end of the studies from all female mice. The length of the estrous cycle and the length of time spent in each stage of the cycle were evaluated.
- Statistics:
- Not reported
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- The only treatment related clinical finding was irritation of the skin at the site of application in males and females administered 800 mg/kg bw.
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- The only treatment related clinical finding was irritation of the skin at the site of application in males and females administered 800 mg/kg bw.
- Mortality:
- no mortality observed
- Description (incidence):
- All mice survived until the end of the study.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Final mean body weights and body weight gains of dosed males and females were similar to those of the vehicle controls.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- The absolute and relative liver and right kidney weights of 800 mg/kg bw males and females and the absolute and relative liver weights of 400 mg/kg bw females were significantly greater than those of the vehicle controls. The absolute and relative lung weights of 800 mg/kg bw females were also significantly greater than those of the vehicle controls.
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Histopathologic lesions of the skin at the site of application included epidermal hyperplasia, sebaceous gland hyperplasia, chronic active inflammation, parakeratosis, and ulcer. The incidences and severities of these skin lesions generally increased with increasing dose in males and females
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- Epididymal spermatozoal concentration was significantly increased in 800 mg/kg bw males. Estrous cycle lengths of dosed females were similar to that of the vehicle controls
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- (systemic effects)
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- organ weights and organ / body weight ratios
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- (local effects)
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: skin inflammation
Target system / organ toxicity
open allclose all
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 400 mg/kg bw/day (actual dose received)
- System:
- other: As of 400 mg/kg bw/d, significant increase in relative liver weights (females). At 800 mg/kg bw/d, significant increase in relative kidney (male and females) and lung (females) weights.
- Organ:
- kidney
- liver
- lungs
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 200 mg/kg bw/day
- System:
- other: As of 200 mg/kg bw/d, incidence of chronic active inflammation.
- Organ:
- skin
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the 14-week NOAEL in mice for systemic effects was considered to be 200 mg/kg bw/day and for the local effects 100 mg/kg bw/day.
- Executive summary:
A study was conducted to evaluate the repeated dose toxicity of the test substance when administered via the dermal route to B6C3F1 mice. The experiment was carried out in compliance with GLP. Groups of 10 male and 10 female mice were exposed to 0, 50, 100, 200, 400 or 800 mg/kg bw/day of the substance in ethanol by dermal application, 5 times per week, for 14 weeks. Mortality, clinical signs and bodyweight were recorded throughout the study. At the end of the study, samples were collected for sperm motility and vaginal cytology evaluations in the 0, 200, 400 and 800 mg/kg bw/day dose groups. At necropsy, a gross macroscopic examination was conducted. Selected organs were weighed and a complete histopathological evaluation was carried out for 0 and 800 mg/kg bw/day mice. All mice survived until the end of the study. The only treatment related clinical finding was irritation of the skin at the site of application in males and females administered 800 mg/kg bw/day. There were no effects on body weight. Weights of the liver and kidney of 800 mg/kg bw/day males and females, liver of 400 mg/kg bw/day females and lung of 800 mg/kg bw/day females were significantly increased compared to the controls. Epididymal spermatozoa concentration was significantly increased in 800 mg/kg bw/day males. Histopathologic lesions of the skin at the site of application included epidermal hyperplasia, sebaceous gland hyperplasia, chronic active inflammation, parakeratosis and ulcer. The incidences and severities of these skin lesions generally increased with increasing dose in males and females. Under the study conditions, the 14 week NOAEL in mice for systemic effects was considered to be 200 mg/kg bw/day and for the local effects 100 mg/kg bw/day (Irwin, 2001).
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.