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EC number: 285-503-5 | CAS number: 85114-00-7
- 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, other
- Remarks:
- Existing in vivo study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 June to 30 June 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study carried out in accordance with OECD 405 (1987) and performed with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- 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:
- 2-hydroxypropyl 2-ethylhexanoate
- EC Number:
- 261-499-0
- EC Name:
- 2-hydroxypropyl 2-ethylhexanoate
- Cas Number:
- 58921-10-1
- Molecular formula:
- C11H22O3
- IUPAC Name:
- 2-hydroxypropyl 2-ethylhexanoate
- Reference substance name:
- 1-hydroxypropan-2-yl 2-ethylhexanoate
- Molecular formula:
- C11H22O3
- IUPAC Name:
- 1-hydroxypropan-2-yl 2-ethylhexanoate
- Reference substance name:
- Monoesters of 2-ethylhexanoic acid and dipropyleneglycol
- IUPAC Name:
- Monoesters of 2-ethylhexanoic acid and dipropyleneglycol
- Reference substance name:
- 1-methylethylene 2-ethylhexanoate
- EC Number:
- 301-185-3
- EC Name:
- 1-methylethylene 2-ethylhexanoate
- Cas Number:
- 93981-97-6
- Molecular formula:
- C19H36O4
- IUPAC Name:
- propane-1,2-diyl bis(2-ethylhexanoate)
- Reference substance name:
- 2-ethylhexanoic acid
- EC Number:
- 205-743-6
- EC Name:
- 2-ethylhexanoic acid
- Cas Number:
- 149-57-5
- Molecular formula:
- C8H16O2
- IUPAC Name:
- 2-ethylhexanoic acid
- Reference substance name:
- Propane-1,2-diol, propoxylated
- EC Number:
- 500-039-8
- EC Name:
- Propane-1,2-diol, propoxylated
- Cas Number:
- 25322-69-4
- IUPAC Name:
- Propane-1,2-diol, propoxylated
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Water
- Test material form:
- liquid: viscous
Constituent 1
Constituent 2
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): SER-AD FX 511
- Physical state: liquid (very pale yellow)
- Analytical purity: no data; the purity of the test material was the responsibility of the sponsor
- Storage condition of test material: room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 w
- Weight at study initiation: 2.88 to 3.10 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 45-64
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
VEHICLE no vehicle used - Duration of treatment / exposure:
- 1 h
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 3 (1 female, 2 males)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed, but it is not considered necessary
The eyes of the animals were examined 1, 24, 48, and 72 h after the test substance application. The light source from a standard ophthalmoscope was used.
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: The light source from a standard ophthalmoscope was used to enable the assessment.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.2
- Max. score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Irritant / corrosive response data:
- No corneal effects were detected. The iris appeared inflammed in one animal at 1 h post-treatment, but it was fully reversible within 24 h. Minimal irritation of the conjuctivae was seen in two animals at 24 h.
Any other information on results incl. tables
Individual irritation scores can be found in the attached document below.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not an eye irritant.
- Executive summary:
In this eye irritation study, 0.5 ml of SER-AD FX 511 was instilled into the conjunctival sac of the right eye of 3 young adult New Zealand White rabbits (1 female and 2 males). Animals were then observed for the following 72 h. Irritation was scored using the Draize scheme for unwashed eyes at time point of 24, 48 and 72 h post-treatment. No corneal effects were detected. The iris appeared inflammed in one animal at 1 h post-treatment, but it was fully reversible within 24 h. Minimal irritation of the conjuctivae was seen in two animals at 24 h. SER-AD FX 511 induced slight irritation that was reversed during the study period. On the basis of this study, SER-AD FX 511 does not warrant classification as being an eye irritant.
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