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EC number: 293-316-5 | CAS number: 91053-50-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Lecithins, acetylated
- EC Number:
- 293-316-5
- EC Name:
- Lecithins, acetylated
- Cas Number:
- 91053-50-8
- Molecular formula:
- Not applicable- complex UVCB substance
- IUPAC Name:
- 91053-50-8
- Details on test material:
- Purity: Unknown variable composition biological substance (UVCBS)
Composition of test material, percentage of components: Unknown variable composition biological substance (UVCBS)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 2132-2717 g
- Housing: Singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 or 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23 ºC
- Humidity (%): 61-73%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light):12 hour light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye of each rabbit was not treated and served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 1, 24, 48, and 72 hours and/or at 4 days post-instillation.
- Number of animals or in vitro replicates:
- 3 animals: 2 male, 1 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes remained unwashed.
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: Ocular irritation was evaluated using a high-intensity white light (Mag Lite)
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:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Corneal opacity was evident in two treated eyes at one hour after dosing, and all three treated eyes exhibited iritis and conjunctivitis. All animals were free of ocular irritation by Day 4. See Table 1 for complete rabbit scores
Any other information on results incl. tables
Table 1: Individual Scores for Ocular irritation
|
Rabbit No.:3401 (male) |
Rabbit No.:3402 (male) |
Rabbit No.:3403 (female) |
||||||||||
Hours |
Hours |
Hours |
|||||||||||
1 |
24 |
48 |
72 |
4 days |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
|
I. Cornea |
|
|
|||||||||||
A. Opacity |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
B. Area |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
II. Iris |
|
||||||||||||
A. Values |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
III. Conjunctivae |
|
||||||||||||
A. Redness |
2 |
2 |
1 |
1 |
0 |
2 |
1 |
1 |
0 |
2 |
2 |
1 |
0 |
B. Chemosis |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
C. Discharge |
2 |
1 |
1 |
1 |
0 |
1 |
1 |
0 |
0 |
2 |
1 |
1 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not classified as an irritant
- Conclusions:
- Corneal opacity was evident in two treated eyes at one hour after dosing, and all three treated eyes exhibited iritis and conjunctivitis. All animals were free of ocular irritation by Day 4.
- Executive summary:
A primary eye irritation test was conducted with rabbits to determine the potential for the test substance to produce irritation from a single instillation via the ocular route. The study was conducted in a stepwise fashion. Initially, 0.1 mL of the test substance was instilled into the conjunctival sac of the right eye of one healthy rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance. The left eye remained untreated and served as a control. Ocular irritation was evaluated by the method of Draize. Since irritation cleared by Day 4 and there was no significant irritation observed in this animal, the test was completed on two additional animals, as described above. Corneal opacity was evident in two treated eyes at one hour after dosing, and all three treated eyes exhibited iritis and conjunctivitis. All animals were free of ocular irritation by Day 4. According to the Globally Harmonized System (GHS) of classification and labelling of chemicals and under the conditions of this study, classification is not required.
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