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Diss Factsheets
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EC number: 919-274-6 | CAS number: -
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted 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
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (see below)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- yes
- Remarks:
- (see below)
- Principles of method if other than guideline:
- The animal room and temperature ranges were outside the allowed ranges on more than one occasion during the study. On day 3 the bodyweight for animal number R1004 was taken prior to written approval from the Study Director. These deviations were not considered to have any impact on the validity of the study.
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Sponsor's identification: AS305BD
Description: dark brown, viscous liquid
Lot number: TS07002
Analytical purity: 100%
Storage conditions: room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Stattion, Tennessee
- Age at study initiation: approximately 11-14 weeks of age
- Weight at study initiation: 2.5-3.3 kg prior to dosing
- Housing: suspended stainless steel cages
- Diet (e.g. ad libitum): PMI Certified Rabbit Chow #5322 (PMI Nutrition International)
- Water (e.g. ad libitum): municipal tap water ad libitum
- Acclimation period: minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 ºC
- Humidity (%): 21-63
- Air changes (per hr): 10-15 per hour
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Each of two rabbits (one animal dosed initially, followed by one additional animal) received a 0.1 mL dose of the test article in the conjunctival sac of the right eye. Following installation, the eyelids were gently held together for approximately one second in order to limit test material loss. The contralateral eye of each animal remained untreated and served as a control.
- Duration of treatment / exposure:
- Test and control eyes were examined for signs of irritation at 1, 24, 48, 72 hours and up to 28 days following dosing according to the Ocular Grading system (see attached Appendix 2). The study was terminated prior to resolution of the ocular irritation.
- Observation period (in vivo):
- 28 Days
- Number of animals or in vitro replicates:
- Two rabbits (one animal dosed initially, followed by one additional animal)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 2
- Reversibility:
- not fully reversible within: 28 Days
- Remarks on result:
- other: 1 of 2 animals reversed by day 14; remaining animal did not reverse at 28 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 1
- Reversibility:
- fully reversible within: Day 14
- Remarks on result:
- other: one animal reversed by day 10.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 2.83
- Reversibility:
- fully reversible within: 21 Days
- Remarks on result:
- other: one animals reversed by day 14
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 2.17
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: one animal reversed by day 10, the other one by day 21
- Irritant / corrosive response data:
- Exposure to the test article produced conjunctivitis (redness, swelling, and discharge), iritis, and corneal opacity in 2/2 test eyes at the 1-hour scoring interval. The conjunctival irritation resolved completely in 1/2 test eyes by the day 14 scoring interval and in the remaining test eye by the day 21 scoring interval. The iritis resolved completely in 1/2 test eyes by the day 10 scoring interval and in the remaining test eye by the day 14 scoring interval. The corneal opacity resolved completely in 1/2 test eyes by the day 14 scoring interval and did not resolve in the remaining test eye by study termination (day 28).
- Other effects:
- Additional findings included neovascularization and hair loss in both animals during the study.
Any other information on results incl. tables
The mean irritation scores at each interval were as follows:
Scoring interval | Corneal opacity | Iritis | Conjunctival redness | Conjunctival chemosis |
24 hours | 1.50 | 1.00 | 2.50 | 2.50 |
48 hours | 2.00 | 1.00 | 3.00 | 2.00 |
72 hours | 2.50 | 1.00 | 3.00 | 2.00 |
24-72 hours mean | 2.00 | 1.00 | 2.83 | 2.17 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Based on the results of this study, the mean 24 hour Draize eye irritation score for AS305BD was 50/110.
- Executive summary:
In line with OCED Guideline 405, the potential irritant and/or corrosive effects of AS305BD was evaluated in the eyes of New Zealnd white rabbits. Each of two rabbits received a dose of 0.1 mL of the test material in the conjunctival sac of the right eye and test and control eyes were observed for 28 days after treatment.
Exposure to the test material produced conjunctivitis (redness, swelling and discharge), iritis and corneal opacity in 2/2 test eyes at the 1 hour scoring interval. The conjunctival irritation resolved completely by the 21 day scoring interval. The iritis resolved completely by the day 14 scoring interval. The corneal opacity did not resolve by study termination.
Based on the results of this study, the mean 24 hour Draize eye irritation score for AS305BD was 50/110 and the test material should be classified as 'irreversible effects on the eye'.
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