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Diss Factsheets
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EC number: 947-718-9 | CAS number: -
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 Feb. - 09 March 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24 February 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- OGYEI National Institute of Pharmacy and Nutrition, H-1051 Budapest, Zrinyi u. 3, 1372 P.O. Box: 450, Hungary
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Isooctadecanoic acid, ester with oxybis[propanediol]
- EC Number:
- 277-361-8
- EC Name:
- Isooctadecanoic acid, ester with oxybis[propanediol]
- Cas Number:
- 73296-86-3
- Molecular formula:
- C24H50O7
- IUPAC Name:
- 16-methylheptadecanoic acid; 3-(2,3-dihydroxypropoxy)propane-1,2-diol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- CRL:(WI)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: young healthy adults
- Weight at study initiation: 214 - 252 g
- Housing: individually in Type II polypropylen/polycarbonate cages with deep wood sawdust to allow digging
- Bedding: Lignocel 3/4-S Hygienic Animal Bedding (J. Rettenmaier & Söhne GmbH & Co. KG, D-73494 Rosenberg, Germany
- Diet: ssniff SM R/M diet (ssniff Spezialdiäten GmbH, D-59494 Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.9 - 24.9
- Humidity (%): 24 - 58
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: 24 February - 9 March 2016
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back of each animal
- % coverage: approx. 10
- Treatment of test site: shaving, 24 h prior to administration
- Type of wrap if used: sterile gauze pad kept in contact with the skin using a patch with adhesive hypoallergenic plaster, the entire trunk of each animal was wrapped with a semiocclusive plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing: residual material was removed with water of body temperature
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: a single dose of 2000 mg/kg bw of the test item was administered - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: on Day 0 at 1 and 5 h after application, once each day for 14 days thereafter
- Frequency of weighing: Day 0 (before administration), Days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross macroscopic examination
Results and discussion
- Preliminary study:
- The test item was not expected to be lethal at 2000 mg/kg bw. A limit test with a single dose of 2000 mg/kg bw was therefore performed.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The test item did not cause mortality at the dose level of 2000 mg/kg bw.
- Clinical signs:
- There were no systemic clinical signs noticed in any animal throughout the study.
- Body weight:
- Body weight gain of all animals showed no indication of a test item-related effect.
- Gross pathology:
- There was no evidence of any adverse effect in the macroscopic observations.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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