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EC number: 947-744-0 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-05-08 to 1984-05-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C16-18 (even numbered), esters with 1,2,3-propanetriol and oligomers, ethoxylated
- IUPAC Name:
- Fatty acids, C16-18 (even numbered), esters with 1,2,3-propanetriol and oligomers, ethoxylated
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL: Hostacerin DGS
- lot/batch No.of test material: E06-400 282 (Date of production 1983-10-25),
- Physical state /colour: white flakes
- Purity test date: about 100 % Diglycerindistearat-Oxethylat, small amount of free stearic acid and polyglycerin
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark at 22 °C
- Stability under test conditions: n.a.
- Solubility of the test substance in the solvent/vehicle: soluble in warmed-up fat
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid: soluble in warmed-up fat
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: n.a.
- Weight at study initiation: 3.0 to 3.2 kg
- Housing: single cages
- Diet (e.g. ad libitum): Altromin 2123 diet - Rabbit, Altromin GmbH, Lage /Lippe
- Water (e.g. ad libitum): deionized, chlorianted water, automated watering place
- Acclimation period: n.a.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): n.a.
- Photoperiod (hrs dark / hrs light): 12 hrs
Test system
- Controls:
- yes, concurrent no treatment
- other: The other eye of each animal serves as untreated control
- Amount / concentration applied:
- 0.1 mL of test item warmed up to about 40°C
- Duration of treatment / exposure:
- 24 hours (24 hours after application the eyes were washed with physiological saline warmed up to 37°C)
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Treated eyes were washed with physiological saline warmed up to 37°C.
- Time after start of exposure: 24 hours after application
SCORING SYSTEM: DRAIZE
TOOL USED TO ASSESS SCORE: Fluorescein- Natrium-Solution (0.01 %); hand-slit lamp, examination of eys under UV-light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- One hour post application of test substance, diffuse to carmesin-red reddening and injected blood vessels were observed at the conjunctivae (one animal score 2, and two animals score 1). 24 hours post application all animals were free of any irritating signs.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this OECD 405 study, the test substance is not irritating to the eye.
- Executive summary:
The test material was tested for primary eye irritation in three New Zealand albino rabbits according to OECD test guideline 405. 0.1 mL of undiluted test substance warmed up to about 40°C was applied once to the conjunctival sac of the left eyes of three rabbits. The untreated eye served as a respective control. The exposure period was 24 hours. 24 hours after instillation and at all the designated examination times at which corneal examination with fluorescein sodium took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C. The eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01 % fluorescein-sodium solution. One hour after treatment the conjunctivae of all animals showed some definitely injected blood vessels as well as a carmesin-red reddening. 24 hours after application all signs of irritation were reversible. The mean irrtation score was determined to be zero.
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