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EC number: 931-468-2 | CAS number: 1190625-94-5
- 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:
- 08 September 2014 to 22 September 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2014
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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF, 12 Nousan, Notification No 8147
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- C14-16-18 Alkyl phenol
- EC Number:
- 931-468-2
- Cas Number:
- 1190625-94-5
- Molecular formula:
- For substance information - see Section 1.2
- IUPAC Name:
- C14-16-18 Alkyl phenol
- Test material form:
- other: slightly viscous liquid
- Details on test material:
- - Appearance: Clear amber liquid
- Storage conditions of test material: At room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Strain: Albino rabbit, New Zealand White, (SPF-Quality)
- Age at study initiation: 12 to 24 weeks
- Weight at study initiation: At least 1.5 kg
- Housing: Animals were individually housed in cages with perforated floors (67 x 62 x 55 cm) and shelters (40 x 32 x 23 cm).
- Diet: Pelleted diet for rabbits, approximately 100 grams per day; hay and wooden sticks
- Water: ad libitum access to tap water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 to 24 °C
- Humidity: 40 to 70 % (relative)
- Air changes: At least 10/hour
- Photoperiod: 12-hour light/12-hour dark cycle
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(s) applied: 0.1 mL - Duration of treatment / exposure:
- Following installation of the test material, the lids were gently held together for about 1 second to prevent loss of the test material.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- PRE-EMPTIVE PAIN MANAGEMENT
One hour prior to instillation of the test material, buprenorphine (Buprenodale®, Dechra Ltd., Stoke-on-Trent, United Kingdom) 0.01 mg/kg was administered by subcutaneous injection in order to provide a therapeutic level of systemic analgesia.
Five minutes prior to instillation of the test material, two drops of the topical anaesthetic alcaine 0.5 % (SA Alcon-Couvreur NV, Puurs, Belgium) were applied to both eyes.
SCORING SYSTEM
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 7 days after instillation of the test material. The irritation scores and a description of all other (local) effects were recorded.
The irritation was assessed according to the numerical scoring system given in Table 1. At each observation, the highest scores given were recorded.
TOOLS USED TO ASSESS SCORE
Where standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an ophthalmic examination lamp. Immediately after the 24-hour observation, a solution of 2 % fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage.
Immediately after fluorescein examination on Day 2, in order to provide a continued level of systemic analgesia, buprenorphine 0.01 mg/kg and meloxicam (Metacam®, Boehringer Vetmed GmbH, Ingelheim/Rhein, Germany) 0.5 mg/kg were administered by subcutaneous injection.
OTHER OBSERVATIONS
- Mortality/Viability: Twice daily
- Toxicity At least once daily
- Body Weight: Day of treatment (prior to instillation) and after the final observation.
- Sacrifice: After the final observation, the animals were sacrificed by intra-venous injection of Euthasol® 20 % (AST Farma BV, Oudewater, The Netherlands). No necropsy was performed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 1hr
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 1hr
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1hr
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Instillation of the test material resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 7 days in all animals.
No iridial irritation or corneal opacity were observed, and treatment of the eyes with 2 % fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.
There was no evidence of ocular corrosion. - Other effects:
- No staining of (peri) ocular tissues by the test material was observed. Remnants of the test material were present on the outside of the eyelids of all animals on Days 1, 2 and/or 3.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Table 1: Individual Eye Irritation Scores
Animal |
Time After Dosing |
Corneal Opacity |
Iris |
Conjunctivae |
||
Redness |
Chemosis |
Discharge |
||||
785 |
1 hour |
0 |
0 |
1 |
1 |
0 |
24 hours |
0 |
0 |
2 |
0 |
1 |
|
8 hours |
0 |
0 |
1 |
0 |
0 |
|
72 hours |
0 |
0 |
1 |
0 |
0 |
|
7 days |
0 |
0 |
0 |
0 |
0 |
|
786 |
1 hour |
0 |
0 |
1 |
1 |
1 |
24 hours |
0 |
0 |
2 |
1 |
1 |
|
8 hours |
0 |
0 |
1 |
0 |
0 |
|
72 hours |
0 |
0 |
1 |
0 |
0 |
|
7 days |
0 |
0 |
0 |
0 |
0 |
|
787 |
1 hour |
0 |
0 |
1 |
1 |
1 |
24 hours |
0 |
0 |
2 |
1 |
1 |
|
8 hours |
0 |
0 |
1 |
0 |
0 |
|
72 hours |
0 |
0 |
1 |
0 |
0 |
|
7 days |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test material was found to be non-irritating to the eye.
- Executive summary:
The potential of the test material to cause acute eye irritation or corrosion was investigated in a study conducted in accordance with the standardised guidelines OECD 405, EU Method B.5, EPA OPPTS 870.2400 and JMAFF, 12 Nousan, Notification No 8147 under GLP conditions.
Single samples of 0.1 mL of the test material were instilled into one eye of each of three New Zealand White rabbits. The other eye remained untreated and served as the reference control. Observations were made 1, 24, 48 and 72 hours and 7 days after instillation.
Instillation of the test material resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 7 days in all animals. No iridial irritation or corneal opacity were observed, and treatment of the eyes with 2 % fluorescein 24 hours after test material instillation revealed no corneal epithelial damage.
Remnants of the test material were present on the outside of the eyelids of all animals on Days 1, 2 and/or 3.
Under the conditions of this study, the test material was found to be non-irritating to the eye.
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