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EC number: 208-021-9 | CAS number: 505-84-0
- 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:
- From 2010-03-22 to 2010-03-29
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Propylal
- IUPAC Name:
- Propylal
- Details on test material:
- - Name of test material (as cited in study report): propylal
- Physical state: colourless liquid
- Analytical purity: 99.80% (w/w)
- Impurities (identity and concentrations): propan-1-ol (0.031%); aldehydes (not found); water (0.0231%)
- Lot/batch No.: 0803211700
- Expiration date of the lot/batch: 21/03/2011
- Storage condition of test material: stored in a closed brown glass vial at laboratory temperature during the study
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: breeding farm VELAZ s.r.o., Kolec u Kladna, Czech Republic, RCH CZ 21760152
- Age at study initiation: 4-5 months
- Weight at study initiation: 3.4-3.7 kg
- Housing: Conventional animal room – individually in metallic cages
- Diet (e.g. ad libitum): Standard pelleted diet TM-MAK 1 for rabbits and guinea pigs ad libidum (producer: Ing. Mrkvicka Miroslav – Vyroba krmnych smesi, Mlyn Kocanda, 252 42 Jesenice u Prahy)
- Water (e.g. ad libitum): Drinking tap water ad libitum (quality corresponding to the Regulation No.: 252/2004 Czech Coll. Of Law)
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C, permanently monitored
- Humidity (%): 30 – 70%, permanently monitored
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1g
- Concentration (if solution): Not relevant
VEHICLE
- Amount(s) applied (volume or weight with unit): Not relevant
- Concentration (if solution): Not relevant
- Lot/batch no. (if required): Not relevant
- Purity: Not relevant - Duration of treatment / exposure:
- Duration of exposure corresponds to duration of observation
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after application, then once daily. After recording the observations at 24 hours, the eyes of rabbit were examined with the aid of fluorescinein and the ophthamoscopy. The grades of ocular reaction for single animal (observation of conjunctivae, cornea and iris) were recorded at each examination.
- Number of animals or in vitro replicates:
- 3 (1 male and 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: Not relevant
SCORING SYSTEM:
CORNEA
0 - No ulceration or opacity
1 - Scattered or diffuse areas of opacity; details of iris clearly visible
2 - Easily discernible translucent area;details of iris slightly obscured
3 – Nacrous area, no details of iris visible, size of pupil barely discernible
4 – Opaque cornea, iris not discernible through the opacy
Maximum possible: 4
IRIS
0 - Normal
1 – Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperemia ; or injection ; iris reactive to light (a sluggish reaction is considered to be an effect)
2 – Hemorrhage, gross destruction, or no reaction to light
Maximum possible: 2
CONJUNCTIVAE
0 - Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris) normal
1 - Some blood vessels hyperarmic (injected)
2 - Diffuse, crimson color, individual vessels not easily discernible
3 - Diffuse beefy red
Maximum possible: 3
CHEMOSIS
0 - Normal no alterations
1 - Some swelling above normal
2 - Obvious swelling with partial eversion of lids
3- Swelling with lids about half closed
4 - Swelling with lids more than half closed
Maximum possible: 4
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #7, #8 and #9
- Time point:
- other: 1h, 24h, 48h and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: #7, #8 and #9
- Time point:
- other: 1h, 24h, 48h and 72h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #7
- Time point:
- other: 1h and 24h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #7
- Time point:
- other: 48h and 72h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #8
- Time point:
- other: 1h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #8
- Time point:
- other: 24h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #9
- Time point:
- other: 1h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #9
- Time point:
- other: 24h, 48h and 72h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #7, #8 and #9
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Irritant / corrosive response data:
- Please refer to "Overall irritation/corrosion results"
- Other effects:
- Clinical observation and body weight are recorded under "Any other information on results incl. tables"
Any other information on results incl. tables
Clinical observation and body weight were recorded in the table below:
Rabbit No. |
Clinical observation |
Body weight (in kg) |
|
prior to application |
at termination |
||
7 |
No changes |
2.40 |
2.60 |
8 |
No changes |
2.40 |
2.70 |
9 |
No changes |
2.30 |
2.50 |
No symptoms of systemic toxicity were observed in the animals during clinical observation in the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Examination of eye irritation after single application demonstrated, that the test substance, prpopylal, was slightly irritating for eye of rabbit, but all signs of irritation disappeared till 5th day afer exposure.
- Executive summary:
The test substance, propylal, was tested for the assessment of eye irritation/corrosion effects using albino rabbit (New Zealand Albino breed).
The test was performed according to the Method B.5 Acute Toxicity: Eye Irritation/Corrosion. Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
The test was performed initially using one animal (No. 7). If the results of this test indicate the substance to be corrosive or a severe irritant to the eye, the response was confirmed using two additional animals (No. 8 and No. 9).
The following changes were observed on eye at 1 hour after application: conjunctivae - diffuse, crimson color, individual vessels not easily discernible; chemosis – some swelling above normal in all rabbits. In one rabbit (No. 9) lacrimation was observed at 1 hour after application. Conjunctivae – diffuse, crimson color, individual vessels not easily discernible or some blood vessels hyperaemic (injected) were observed in all rabbits at the 24 hours after application. Conjunctivae – some blood vessels hyperaemic (injected) were observed in two rabbits at the 48 and 72 hours after application. Changes on the conjunctivae in one animal (No. 9) persisted to the 4th day after application. On the 5th day no alterations appeared. No clinical signs of systemic intoxication were detected.
Examination of eye irritation after single application demonstrated, that the test substance, prpopylal, was slightly irritating for eye of rabbit, but all signs of irritation disappeared till 5th day afer exposure.
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