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EC number: 276-974-8 | CAS number: 72901-31-6
- 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
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa-Credo, Brussels, Belgium
- Age at study initiation: 9-10 weeks
- Weight at study initiation: males 326-352 g, females 206-238 g
- Fasting period before study: yes, feed was withheld twice; once overnight before first dosing until approximately 3-3.5 hours after administration and a second time 10-11 hours overnight before the second dosing until approximately 4 hours after administration of the test substance. Between the two fasting periods there was a 3-hour feeding period.
- Housing: Individually in polycarbonate cages; Bedding material (purified sawdust, Woody Clean, was recceived from the Broekman Institute, Someren, The Netherlands).
- Diet (e.g. ad libitum): Standard laboratory animal diet (RMH-B, pellet diameter 10 mm), which was obtained from Hope Farms, Woerden, The Netherlands, ad libitum.
- Water (e.g. ad libitum): Tap water, ad libitum.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 50-95
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 160 mg/mL
- Amount of vehicle (if gavage): 7.5 mL
- Justification for choice of vehicle: very low water solubility of test substance
MAXIMUM DOSE VOLUME APPLIED: 2 times 7.5 mL/kg within 24 hours
DOSAGE PREPARATION (if unusual):
The test substance was heated to melting point (approximately 60 °C) and suspended in corn oil (maydis oleum, ACF, Maarssen, The Netherlands). Prior to dosing the suspension was heated to approximately 65 °C and was transferred to a glass syringe; subsequently the syringe was cooled under running cold tap-water and the suspension was administered using a stainless steel cannula. - Doses:
- 2400 mg/kg bw (twice 1200 mg/kg bw : maximum dose feasible for oral administraion)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Cage side observations on the day of dosing (approx. once every 2 hours) and daily thereafter. With exception of weekends and holidays a mortality check was performed at the end of the day. Individual body weights (with group means and standard deviation) were measured weekly.
- Necropsy of survivors performed: yes, at the end of the study (Day 14) all surviving animals were sacrificed by CO2-asphyxiation and subjected to autopsy.
- Other examinations performed: clinical signs, body weight - Statistics:
- Body weight group means with standard deviations.
- Preliminary study:
- In order to establish an appropriate dose range six groups of Wistar rats, each comprising 1 male and 1 female, were dosed with an oral dose of the test substance at 2400, 1800, 1000, 560, 320 and 180 mg/kg bw, respectively. No mortalities occurred and no signs of systemic toxicity were observed during the 7-day observation period.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 400 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 400 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- No signs of systemic toxicity were observed during the 14-day observation period with exception of Day 1 when lethargy was frequently observed. There was no evident sex-related effect.
- Body weight:
- Weekly group mean body weight gain was normal. There was no evident sex-related effect.
- Gross pathology:
- There were no test substance-related gross abnormalitites.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute LD50 in male and female Wistar rats administered oleyl palmitamide orally is >2,400 mg/kg.
- Executive summary:
The acute LD50 in male and female Wistar rats administered oleyl palmitamide orally is >2,400 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 400 mg/kg bw
- Quality of whole database:
- The read-across (CAS 16260-09-6) rat acute oral LD50 is >2400 mg/kg. This is a GLP, guideline study performed in 1986.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- The vapor pressure of CAS 72901-31-6 is 2.6E-16 mmHg@25 degrees C. For chemicals with a vapor pressure < 10E-6 there is low concern for inhalation exposure.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Test article was oleyl palmitamide (CASRN 16260-09-6).
- Species:
- rat
- Strain:
- other: RccHan:WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: at least 200 g, weight variation did not exceed ±20% of the mean for each sex
- Fasting period before study: not required
- Housing: housed individually during the 24-h exposure period and in groups of five, by sex, for the remainder of the study in suspended solid-floor polypropylene cages furnished with woodflakes. Animals were provided with environmental enrichment items considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Diet: 2014C Teklad Global Rodent diet (Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- arachis oil
- Details on dermal exposure:
TEST SITE
- Area of exposure: clipped back and flanks
- % coverage: approximately 10% of the total body surface area
- Type of wrap if used: a piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated skin and surrounding hair were wiped with cotton wool moistened with arachis oil BP to remove any residual test item.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable, only used for moistening of the test substance- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual body weights were recorded prior to application on Day 0 and on Days 7 and 14
- Necropsy of survivors performed: yes, all animals
- Other examinations performed: clinical signs, body weight, external examination, opening of the abdominal and thoracic cavities, appearance of macroscopic abnormalities. After removal of the dressings and subsequently once daily for fourteen days the test sites were examined for primary irritation and scored according to the criteria of Draize (1977).- Statistics:
- Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD50) of the test item was made.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality occurred.
- Clinical signs:
- No signs of systemic toxicity were observed.
- Body weight:
Animals showed expected gains in bodyweight over the study period except for one male which showed bodyweight loss during the first week but expected gain in bodyweight during the second week.- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- - Other observations: Dermal reactions: very slight erythema was noted at the test sites of 4/5 females (score 1) which abated after 5 days in 3 females and after 8 days in the fourth. There were no signs of dermal irritation noted at the test sites of the remaining animals.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bw.
- Executive summary:
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The read-across (CAS 16260-09-6) dermal LD50 is >2000 mg/kg. This is a GLP, guideline study.
Additional information
Justification for classification or non-classification
Acute oral toxicity: 2400 mg/kg bw
Acute inhalation toxicity: study waived due to vapor pressure <10E-6.
Acute dermal toxicity: >2000 mg/kg bw
Based on this information no classification for accute toxcity according to Regulation (EC) 1272/2008 and amendments is warranted.
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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