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EC number: 600-687-2 | CAS number: 105839-18-7
- 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
- Remarks:
- other: Preliminary study: In vitro, Main test: In vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 September 2012 to 28 March 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully GLP compliant and in accordance with current test guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Remarks:
- Preliminary study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Test material form:
- other: Viscous semi-solid
- Details on test material:
- Name: MonoFA_TETA_PAA_BADGE_BGE_Adduct
CAS number: 105839-18-7
Batch number: WA521
Purity: 100%
Expiry date: 28 February 2014
Receipt date: 03 September 2012
Storage: stored in a sealed container, at 15 to 25ºC, 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
- Source: Harlan UK Ltd., Bicester
- Age at study initiation: 17 to 18 Weeks
- Weight at study initiation: Not reported
- Housing: the rabbit was housed in a cage that conformed to the 'Code of Practice for the Housing and Care of Animals Used in Scientific Procedures' (Home Office, London, 1989).
- Diet (e.g. ad libitum): Global Diet 2930C (Harlan Teklad, Bicester, UK), ad libitum
- Water (e.g. ad libitum): Mains water, ad libitum
- Acclimation period: 9 Weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 to 22°C
- Humidity (%): > 45%
- Air changes (per hr): The animal room was designed to permit 15 to 20 air changes per hour.
- Photoperiod (hrs dark / hrs light): The rooms were illuminated by fluorescent strip-lights for twelve hours daily.
IN-LIFE DATES: From: 10 December 2012 To: 14 December 2012
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- One dose consisting of 0.1 mL of undiluted test article was instilled into the left conjunctival sac of a single New Zealand White rabbit (the sentinel).
- Duration of treatment / exposure:
- 4 Days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- Before the animal could be dosed, the pH of the test article was checked. A 50% w/v dispersion in purified water had a pH of 6. Since this was within the acceptable range of pH 2.0 to 11.5, the study continued.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 Hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 Hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- > 3 - < 4
- Max. score:
- 4
- Reversibility:
- not specified
- Irritant / corrosive response data:
- Preliminary test results (In vitro experiment)
Corneas treated with the test article were noted to be slightly opaque.
Corneas treated with the positive control article were cloudy and blistered.
The mean opacity reading for the test article was 7.0, for the negative control was 0.0 and for the positive control was 65.3.
The mean group corrected optical density for the test article was 0.232 for the negative control was 0.0 and for the positive control was 0.588.
The test article produced an IVIS score of 10.47.
In vivo experiment
Dulling of the normal lustre of the cornea was noted 4 hours after instillation, with easily discernible translucent areas of corneal opacity noted from 24 to 72 hours after treatment.
Iridial inflammation was noted at all time points from 30 minutes to 72 hours after instillation.
Moderate conjunctival irritation was noted 30 minutes and 1 hour after instillation with severe conjunctival irritation noted 4 hours after instillation persisting to the end of the observation period.
Maximal conjunctival inflammation (swelling grade 4 and redness grade 3) was noted 24 after instillation with no evidence of recovery within 48 hours. The animal was therefore humanely killed in accordance with the UK Home Office Guidelines on Eye Irritation Tests (published March 2006).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The test article was considered to be severely irritating to eyes and was classified as Category 1 (causing irreversible effects on the eye) according to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS).
- Executive summary:
This study was conducted to determine whether the test article has a potential to cause corrosion or irritation to the eye.
Initially the test article was evaluated using an in vitro test system, the bovine corneal opacity and permeability assay (BCOP). A volume of 750 µL of the test article formulation was applied to each of three corneas followed by a 10 minute incubation at 32 ± 1°C. After this incubation, each cornea was washed with media containing phenol red followed by media without phenol red, the opacities measured and then the anterior chamber emptied. For the permeability endpoint, sodium fluorescein solution was added into the anterior chamber and the corneas were incubated in the vertical position for 1.5 hours ± 5 minutes. Following this period, the media in the posterior chamber was removed and three 350 μL aliquots of this media (per cornea) were analysed for optical density at 490 nanometers (OD490).
A volume of 750 µL of the negative or positive control was similarly applied to further groups of three corneas. These corneas were subject to the procedures detailed above.
Corneas treated with the test article were noted to be slightly opaque. Corneas treated with the positive control article were cloudy and blistered. The mean opacity reading for the test article was 7.0, for the negative control was 0.0 and for the positive control was 65.3. The mean group corrected optical density for the test article was 0.232 for the negative control was 0.0 and for the positive control was 0.588. The test article produced an IVIS score of 10.47 and was not considered to be corrosive or severely irritating to the eye according to the BCOP assay.
An in vivo eye irritation test was therefore conducted. The undiluted test article (0.1 mL) was instilled into one conjunctival sac of a New Zealand White rabbit on Day 1. Ocular reactions were assessed for three days after treatment.
Dulling of the normal lustre of the cornea was noted 4 hours after instillation, with easily discernible translucent areas of corneal opacity noted from 24 to 72 hours after treatment. Iridial inflammation was noted at all time points from 30 minutes to 72 hours after instillation. Moderate conjunctival irritation was noted 30 minutes and 1 hour after instillation with severe conjunctival irritation noted 4 hours after instillation persisting to the end of the observation period.
Maximal conjunctival inflammation (swelling grade 4 and redness grade 3) was noted 24 after instillation with no evidence of recovery within 48 hours. The animal was therefore humanely killed in accordance with the UK Home Office Guidelines on Eye Irritation Tests (published March 2006).
The test article was considered to be severely irritating to eyes and was classified as Category 1 (causing irreversible effects on the eye) according to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS).
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