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EC number: 812-111-9 | CAS number: 188959-24-2
- 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
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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Active enzyme protein of Lipase, triacylglycerol (EC no. 232-619-9, CAS no. 9001-62-1, EC name: Lipase, triacylglycerol, Enzyme Class No.: 3.1.1.3)
- Molecular formula:
- Not applicable, see remarks
- IUPAC Name:
- Active enzyme protein of Lipase, triacylglycerol (EC no. 232-619-9, CAS no. 9001-62-1, EC name: Lipase, triacylglycerol, Enzyme Class No.: 3.1.1.3)
- Reference substance name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available
- IUPAC Name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Test material form:
- liquid
- Details on test material:
- Substance type: UVCB
Physical state: translucent tan liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Inc., Denver, PA
- Age at study initiation: 125 days old
- Weight at study initiation: 2.8 kg
- Housing: The animals were housed 1/cage in suspended cages. Paper bedding was placed beneath the cages and changed at least three times/week.
- Diet (e.g. ad libitum): PMI Rabbit Chow (Diet #5321) provided daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Temperature was controlled but details were not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One eye of each rabbit was dosed. The contralateral eye served as a control.
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- Observations were made at 1, 24, 48, and 72 hours after instillation
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: Eyes were not washed after dosing
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: Using a Mini-Mag lite® flashlight equipped with a high intensity bulb, the treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours postdose. Sodium fluorescein dye procedures were used at the 24-hour observation interval. The eye was examined with the aid of an ultraviolet light source. Sodium fluorescein dye procedures were used at the 24-hour observation interval.
Body weights were recorded pretest and at termination. The general health of the animals was monitored at each observation time.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- There was no corneal opacity or iritis noted at any observation period. Conjunctiva! irritation, noted in 1/3 eyes, cleared by 24 hours.
- Other effects:
- There were no abnormal physical signs noted during the observation period. Body weights were normal.
Any other information on results incl. tables
Table 1 - Ocular Findings and Systemic Observations
Animal # |
Item |
Tissue |
Reading |
At 1 hour |
At 24 hours |
At 48 hours |
At 72 hours |
1 |
A B |
Cornea |
Opacity Area |
0 0 |
0 0 |
0 0 |
0 0 |
|
C |
Iris |
|
0 |
0 |
0 |
0 |
|
D E F |
Conjunctiva |
Redness Chemosis Discharge |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
Systemic observations |
|
|
Normal |
Normal |
Normal |
Normal |
|
Sodium Fluorescein |
|
|
Not done |
0 |
Not done |
Not done |
Animal # |
Item |
Tissue |
Reading |
At 1 hour |
At 24 hours |
At 48 hours |
At 72 hours |
2 |
A B |
Cornea |
Opacity Area |
0 0 |
0 0 |
0 0 |
0 0 |
|
C |
Iris |
|
0 |
0 |
0 |
0 |
|
D E F |
Conjunctiva |
Redness Chemosis Discharge |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
Systemic observations |
|
|
Normal |
Normal |
Normal |
Normal |
|
Sodium Fluorescein |
|
|
Not done |
0 |
Not done |
Not done |
Animal # |
Item |
Tissue |
Reading |
At 1 hour |
At 24 hours |
At 48 hours |
At 72 hours |
3 |
A B |
Cornea |
Opacity Area |
0 0 |
0 0 |
0 0 |
0 0 |
|
C |
Iris |
|
0 |
0 |
0 |
0 |
|
D E F |
Conjunctiva |
Redness Chemosis Discharge |
0 0 1 |
0 0 0 |
0 0 0 |
0 0 0 |
|
Systemic observations |
|
|
Normal |
Normal |
Normal |
Normal |
|
Sodium Fluorescein |
|
|
Not done |
0 |
Not done |
Not done |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Irritation obseerved in 1/3 rabbits cleared by 24 hours. No corneal opacity or iritis was noted at any observation period.
- Executive summary:
To determine the irritant or corrosive effects, if any, of a test article when instilled into the rabbit eye in accordance with OECD Test Guideline 405. One eye of each rabbit was dosed. The contralateral eye served as a control. The test article (0.1 mL) was placed by syringe into the conjunctival sac that was formed by gently pulling the lower eyelid away from the eye. After instillation, the lids were held together for approximately one second to insure adequate distribution of the test article. Using a Mini-Mag lite® flashlight equipped with a high intensity bulb, the treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours post-dose. Sodium fluorescein dye procedures were used at the 24-hour observation interval. The eye was examined with the aid of an ultraviolet light source. Ocular reactions were graded according to the numerical Draize technique. Body weights were recorded pretest and at termination. The general health of the animals was monitored at each observation time.
There was no corneal opacity or iritis noted at any observation period. Conjunctiva! irritation, noted in 1/3 eyes, cleared by 24 hours. There were no abnormal physical signs noted during the observation period. Body weights were normal.
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