Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 213-510-5 | CAS number: 961-69-3
- 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:
- end on 8 July 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: screening test, sufficiently described
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- screening test, only one animal used
- GLP compliance:
- no
Test material
- Reference substance name:
- Potassium (R)-[(3-ethoxy-1-methyl-3-oxoprop-1-enyl)amino]phenylacetate
- EC Number:
- 213-510-5
- EC Name:
- Potassium (R)-[(3-ethoxy-1-methyl-3-oxoprop-1-enyl)amino]phenylacetate
- Cas Number:
- 961-69-3
- Molecular formula:
- C14H17NO4.K
- IUPAC Name:
- potassium [(3-ethoxy-1-methyl-3-oxoprop-1-en-1-yl)amino](phenyl)acetate
- Details on test material:
- - Name of test material (as cited in study report): FG-KZE
- Substance type: monoconstituent substance
- Physical state: data not available
- Analytical purity: data not available
- Impurities (identity and concentrations): data not available
- Purity test date: data not available
- Lot/batch No.: 989 A
- Expiration date of the lot/batch: data not available
- Stability under test conditions: data not available
- Storage condition of test material: data not available
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source, Age at study initiation, Weight at study initiation, Fasting period before study, Housing, Diet, Water, Acclimation period: data not available
ENVIRONMENTAL CONDITIONS
- Temperature, Humidity, Air changes, Photoperiod: data not available
IN-LIFE DATES: data not available
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye remained untreated and served as the reference control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 50 mg (specific gravity: 0.5)
- Concentration: undiluted - Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- one animal
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Draize scale, according to OECD guideline
TOOL USED TO ASSESS SCORE: data not available
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean value (24, 48, 72h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean value (24, 48, 72h)
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean value (24, 48, 72h)
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean value (24, 48, 72h)
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Instillation of FG-KZE (batch 989 A) in a rabbit eye resulted in adverse effects on the cornea, iris and the conjunctivae. The iridic irritation had resolved within 7 days, the corneal injury had resolved w ithin 14 days and the irritation of the conjunctivae had resolved within 21 days after instillation.
- Other effects:
- At 1 h: The size of the pupil of the treated eye was reduced in comparison with the pupil of the reference eye. Grey/white discolouration of the nictitating membrane, as a sign of necrosis.
At 1, 24, 48 and 72h: Grey/white discolouration of the nictitating membrane and eyelids, as a sign of necrosis. Lacrimation was observed.
At 7 days: Neovascularisation of the cornea. Grey/white discolouration of the nictitating membrane and eyelids, as a sign of necrosis.
Any other information on results incl. tables
Table 1: Irritant/corrosive response
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
1 |
1 |
3 |
2 |
24 h |
1 |
1 |
3 |
2 |
48 h |
1 |
1 |
3 |
2 |
72 h |
1 |
1 |
3 |
1 |
7 days |
1 |
0 |
3 |
0 |
14 days |
0 |
0 |
1 |
0 |
21 days |
0 |
0 |
0 |
0 |
Average 24h, 48h, 72h |
1 |
1 |
3 |
1.7 |
Reversibility*) |
yes |
yes |
yes |
yes |
Average time (unit) for reversion |
After 14 days |
After 7 days |
After 21 days |
After 7 days |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- PG-ds (potassium (R)-[(3-ethoxy-1-methyl-3-oxoprop-1-enyl)amino]phenylacetate) is an eye irritant.
- Executive summary:
In a primary eye irritation study, 50 mg of undiluted PG-ds (potassium (R)-[(3-ethoxy-1-methyl-3-oxoprop-1-enyl)amino]phenylacetate) was instilled into the conjunctival sac of one eye of an albino rabbit (New Zealand White) after gently pulling the lower lid away from the eyeball. The lids were gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control. Irritation was scored by the method of Draize.
Instillation of PG-ds (potassium (R)-[(3-ethoxy-1-methyl-3-oxoprop-1-enyl)amino]phenylacetate) in a rabbit eye resulted in adverse effects on the cornea, iris and the conjunctivae. The iridic irritation had resolved within 7 days, the corneal injury had resolved w ithin 14 days and the irritation of the conjunctivae had resolved within 21 days after instillation.
According to the EEC criteria for classification and labelling requirements, the mean value of the scores for each type of lesion is the following (mean of 24, 48 and 72h):
- Corneal opacity: 1
- Iris: 1
- Conjunctivae (redness): 3
- Conjunctivae (chemosis): 1.7
In this study, PG-ds (potassium (R)-[(3-ethoxy-1-methyl-3-oxoprop-1-enyl)amino]phenylacetate) is an eye irritant based on EU criteria (according to DSD and CLP).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
