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EC number: 269-125-8 | CAS number: 68187-80-4
- 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 analogue amides, C18-unsatd., N, N-bis(hydroxyethyl) is not considered to have carcinogenic potential.
On this basis, it is assumed that HE Rape Oil, reaction product with diethanolamine will not have carcinogenic potential either.
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
Link to relevant study records
- Endpoint:
- carcinogenicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From 06 May 1993 to 16 May 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment and compliant with GLP. Conducted on the structural analogue oleic acid diethanolamine condensate.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A 2-year toxicity study in F344/N rats was conducted by NTP to evaluate the carcinogenic potential by the repeated dermal exposure to the test substance.
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Taconic Laboratory Animals and Services (Germantown, NY)
- Age at study initiation: 7 wk
- Housing: Housed individually in Polycarbonate cages
-Method of distribution: Animals were distributed randomly into groups of approximately equal initial mean body weights.
- Bedding: Sani-Chip® heat-treated hardwood chips (P.J. Murphy Forest Products Corp., Montville, NJ), changed weekly
- Diet: NIH-07 open formula pelleted diet (Zeigler Brothers, Inc., Gardners, PA), available ad libitum
- Water: Tap water (Columbus municipal supply) via automatic watering system (Edstrom Industries, Inc., Waterford, WI), available ad libitum
- Acclimation period:Time held before studies: Males: 13 d and Females: 14 d
- Cages: Polycarbonate (Lab Products, Inc., Maywood, NJ), changed weekly and rotated every 2 wks
- Animal number per cage: 1
- Cage Filters: Spun-bonded polyester Du Pont 2024 (Snow Filtration, Co., Cincinnati, OH), changed every 2 wks
- Racks: Stainless steel drawer-type (Lab Products, Inc., Maywood, NJ), changed and rotated every 2 wks
ENVIRONMENTAL CONDITIONS
- Temperature: 21.1-23.3°C
- Relative humidity: 31-73 %
- Air changes: 10/h
- Photoperiod: 12 h dark/12 h light
IN-LIFE DATES: From: 1993-05-06 To: 1995-05-16 - Route of administration:
- dermal
- Vehicle:
- ethanol
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The dose formulations were prepared every 3 weeks by mixing the test substance by stirring or sonicating with 95% ethanol to give the required concentrations. The test substance formulations were applied on shaved skin of the test animals.
-The dose formulations were stored at room temperature, protected from light, in amber glass bottles for up to 28 days. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Periodic analyses of the dose formulations of the test substance from the beginning, middle, and end of the studies were analyzed at the study laboratory using HPLC. All the samples from the formulations were analysed every 9 weeks during the 2-year study and were within 10% of the target concentration.
-Stability of dose formulations: Stability was confirmed for at least 28 days when stored in sealed containers, protected from ultraviolet light, at up to room temperature or for 3 hours when stored open to air and light. - Duration of treatment / exposure:
- 2-yrs
- Frequency of treatment:
- 5 exposures/wk
- Post exposure period:
- No
- Remarks:
- Doses / Concentrations:
0, 50, 100 mg/kg bw/day (0, 85 or 170 mg/mL in ethanol)
Basis:
nominal conc. - No. of animals per sex per dose:
- 50/sex/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Dose selection rationale: The dose selection was based primarily on the incidences and severities of skin lesions observed at the site of application during the 13-week dermal studies. The doses of 200 and 400 mg/kg bw/day exhibited reduced mean body weight and body weight gain along with high incidences of skin lesions at the site of application; thus were considered inappropriate for a 2-year study. Further, lesions of the skin were also present at the site of application in groups administered 100 mg/kg bw/day; however, the incidence were less than those observed in the 200 and 400 mg/kg bw/day groups. Moreover, it was considered unlikely that these lesions would progress and become life threatening over the period of a 2-year study. Therefore, 100 mg/kg bw/day was selected as the high dose for rats in the 2-year study. In groups treated with 50 mg/kg bw/day, the incidences of skin lesions diminished considerably and lesion severities were minimal. Therefore, 50 mg/kg bw/day was selected as the low dose.
- Positive control:
- No
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Clinical findings were recorded monthly and at the end of the studies.
BODY WEIGHT: Yes
- Time schedule for examinations: Weighed initially, weekly for 13 weeks, approximately monthly thereafter and again at the end of the studies
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No - Sacrifice and pathology:
- SACRIFICE: At the end of the 2-year study animals were sacrificed by carbon dioxide asphyxiation.
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
- Complete histopathology was performed on all the rats at the end of the study. In addition to gross lesions and tissue masses, the tissues examined were: adrenal gland, bone with marrow, brain, clitoral gland, esophagus, gallbladder (mice), heart with aorta, large intestine (cecum, colon and rectum), small intestine (duodenum, jejunum and ileum), kidney, liver, lung, lymph nodes (mandibular and mesenteric), mammary gland, nose, ovary, pancreas, parathyroid gland, pituitary gland, preputial gland, prostate gland, salivary gland, skin (site of application), spleen, stomach (forestomach and glandular), testis with epididymis and seminal vesicle, thymus, thyroid gland, trachea, urinary bladder, and uterus.
- All major tissues were fixed and preserved in 10% neutral buffered formalin processed and trimmed, embedded in paraffin, sectioned to a thickness of 5 to 6 μm, and stained with hematoxylin and eosin for microscopic examination. - Other examinations:
- None
- Statistics:
- Survival Analyses: The probability of survival was estimated by the product-limit procedure of Kaplan and Meier (1958). Possible dose-related effects on survival were analysed by Cox’s (1972) method for testing two groups for equality and Tarone’s (1975) life table test to identify dose-related trends. All reported P values for the survival analyses were two sided.
- Analysis of neoplasm and non-neoplastic lesion incidences: The Poly-k test (Bailer and Portier, 1988; Portier and Bailer, 1989; Piegorsch and Bailer, 1997) was used to assess neoplasm and nonneoplastic lesion prevalence. Tests of significance included pair wise comparisons of each dosed group with controls and a test for an overall dose-related trend. Continuity-corrected tests were used in the analysis of lesion incidence, and reported P values are one sided. Values of P greater than 0.5 are presented as 1-P with the letter N added to indicate a lower incidence or negative trend in neoplasm occurrence relative to the control group (e.g., P=0.99 is presented as P=0.01N).
Analysis of Continuous Variables: Organ and body weight data were analysed using the parametric multiple comparison procedures of Dunnett (1955) and Williams (1971, 1972). - Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- (no effects on survival, but there was a treatment-related mild to moderate irritation of the skin at the site of application in dosed males and females; vehicle control, 0/50; 50 mg/kg bw/day, 17/50; 100 mg/kg bw/day, 32/50; females: 3/50, 46/50, 50/50).
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- (no effects on survival, but there was a treatment-related mild to moderate irritation of the skin at the site of application in dosed males and females; vehicle control, 0/50; 50 mg/kg bw/day, 17/50; 100 mg/kg bw/day, 32/50; females: 3/50, 46/50, 50/50).
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- (reduced mean body weights of males (i.e., slightly) and females at 100 mg/kg bw/day ).
- 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
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- (see below under the 'details on results' section)
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- (see below under the 'details on results' section)
- Details on results:
- Histopathology:
- Non-neoplastic lesions:
- Skin lesions: Minimal to moderate non-neoplastic lesions of the skin at the site of application were observed. The major alterations included (thickening of the epidermis, sebaceous gland and epidermal hyperplasia, hyperkeratosis, parakeratosis, chronic active dermal inflammation and ulcer) which were significantly increased in dosed males and females relative to the vehicle control.
- Forestomach lesions: No significant treatment related effects were observed. The increased incidence of hyperkeratosis and ulceration in 50 mg/kg bw/day males were not considered to be treatment related as these effects were not observed in females.
- Testis: No significant treatment related effects were observed.
- Thyroid gland lesions: No significant treatment related effects were observed.
- Neoplastic lesions:
- Skin lesions: No significant treatment related effects were observed. Few observed skin neoplasms (one subcutaneous fibroma in one vehicle control male and one subcutaneous fibrosarcoma in each of the 50 and 100 mg/kg bw/day male groups) were not considered to be significant as the incidences did not follow a pattern indicative of an association with the test substance.
- Testis: No significant treatment related effects were observed. Increased interstitial cell adenoma in males at 100 mg/kg bw/day was not considered significant as similar incidences were reported in vehicle controls in historical NTP dermal studies.
- Thyroid gland: No significant treatment related effects were observed. Marginal increase in the incidence of follicular cell adenoma or carcinoma observed in males at 50 mg/kg bw/day was not considered dose related and no follicular cell hyperplasias were observed . - Relevance of carcinogenic effects / potential:
- No, there were no significant neoplasms associated with administration of the test substance.
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no evidence of carcinogenic activity at any tested dose levels
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Dose descriptor:
- NOAEL
- Remarks:
- (systemic effects)
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: body weight changes at the LOAEL
- Remarks on result:
- other: Effect type: toxicity (migrated information)
- Dose descriptor:
- LOAEL
- Remarks:
- (local effects)
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: irritation and non-neoplastic lesion of the skin at both the tested doses
- Remarks on result:
- other: Effect type: toxicity (migrated information)
- Conclusions:
- Under the test conditions, no evidence of carcinogenic activity was observed with the test substance at any tested dose levels in rats.
- Executive summary:
A study was conducted by NTP to evaluate the carcinogenic potential following repeated dermal exposure to oleic acid diethanolamine condensate (ODEA) in F344/N rats.
Groups of 50 male and 50 female rats were dermally exposed to 0, 50 or 100 mg test substance/kg bw/day in ethanol at a frequency of 5 d/wk for a period of 104 weeks. Survival, clinical findings, body weight and histopathology of different organs were evaluated at specific time intervals.
Survival of the dosed male and female rats was similar to that of the vehicle control groups. 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.
Reference
None
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 the structural analogue amides, C18 -unsatd., N, N-bis(hydroxyethyl) is not considered to have carcinogenic potential. On this basis, it is assumed that HE Rape Oil, reaction product with diethanolamine will not have carcinogenic potential either. Therefore based on the overall weight of evidence, the registered substance 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 structural analogue oleic acid diethanolamine condensate (ODEA) in rats and mice and have been thoroughly 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 on the structural analogue oleic acid diethanolamine condensate and appropriate to base the assessment on.
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