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Diss Factsheets
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EC number: 273-159-9 | CAS number: 68951-62-2
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From November 27, 2012 to January 24, 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- KL2 due to RA
- Justification for type of information:
- Refer to section 13 of IUCLID for details on the read-across justification. The study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: approximately 8 weeks old on the day of treatment
- Mean body weight at study initiation: 201 g (range: 191 g to 208 g)
- Fasting period before study: yes, during the night before treatment
- Housing: the animals were housed by three from the same group in polycarbonate cages with stainless steel lids (Techniplast 2154, 940 cm2)
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: at least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h.
IN-LIFE DATES: 04 December 2012 to 26 December 2012. - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/kg
- Maximum dose-volume applied: 10 mL/kg
DOSAGE PREPARATION (if unusual): The test substance was administered as a homogenous suspension in the vehicle. Although the test substance was a wax, it was ground to a fine powder, using a mortar and pestle, and then mixed with the required quantity of vehicle. Dose formulations preparations were prepared by the CiToxLAB France Pharmacy extemporaneously on the day of each administration. The dose formulations were stored at room temperature and delivered to the study room in brown flasks.
CLASS METHOD (if applicable):
- Rationale for the selection of the starting dose: The starting dose-level was selected in agreement with the Sponsor, based on available test item toxicity data, no morbidity or mortality was expected to occur at the dose level of 2000 mg/kg. This was therefore chosen as the starting dose-level. After treatment at the starting dose-level, the next dose-level was administered in a sequential manner, under the same conditions to different animals, based on the dose-levels indicated in the flow charts of OECD Guideline No. 423, 17th December 2001, which are equivalent to those of Commission Regulation (EC) No. 440/2008, B.1tris (30 May 2008). Based on the results obtained for groups 1 and 2, a third group was not tested. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 females per treatment step
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 d
- Clinical observations: frequently during the hours following treatment; then once a day
- Body weight: just before treatment on Day 1; then on Days 8 and 15
- Necropsy of survivors performed: yes (macroscopic) - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No unscheduled deaths occurred during the study.
- Clinical signs:
- other: No clinical signs were observed in any animals.
- Gross pathology:
- There were no macroscopic post-mortem observations.
- Interpretation of results:
- other: Not classifed based on EU CLP Criteria
- Conclusions:
- Based on the results of the read across study, similar oral LD50 value of >2000 mg/kg bw can be considered for the test substance, C16-18 AMP.
- Executive summary:
A study was conducted to determine the acute toxicity of the read across substance, Oleamide MIPA, according to OECD Guideline 423 and EU Method B1, Acute Toxic Class Method, in compliance with GLP. The test substance was administered once by the oral route (gavage) to two groups of three fasted female Sprague-Dawley rats under a dosage-volume of 10 mL/kg. The test substance was prepared in corn oil. Based on available data, the starting dose-level of 2000 mg/kg bw was chosen. After the first assay, as no toxicity was observed, the results were confirmed in three other females. Each animal was observed at least once a day for mortality and clinical signs for 15 days. Body weight was recorded on the day of allocation of the animals into groups, then on Days 1, 8 and 15. On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination. No tissues were preserved. No unscheduled deaths occurred during the study and no clinical signs were observed in any animals. When compared to study laboratory historical control data and taking into account the initial body weight values, a lower body weight gain was noted in 1/6 females between days 1 and 8 and in 2/6 females between Days 8 and 15. In addition, an overall lower body weight gain was observed in 1/6 females between Days 1 and 15. The test substance had no effect on the body weight evolution, as these lower body weight gains were considered to be minimal and of fortuitous occurrence. There were no macroscopic post-mortem observations. Under study conditions, the oral LD50 of the test substance, was determined to be >2000 mg/kg bw in rats (Papineau, 2013). Based on the results of the read across study, similar oral LD50 value of >2000 mg/kg bw can be considered for the test substance, C16-18 AMP.
- Reason / purpose for cross-reference:
- data waiving: supporting information
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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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