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Diss Factsheets
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EC number: 700-757-3 | 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November-December 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Severe signs of irritation were observed following the administration of the test item to the first animal. The remaining two animals were therefore not treated for animal welfare reasons.
- GLP compliance:
- yes
Test material
- Reference substance name:
- GLYPHO
- IUPAC Name:
- GLYPHO
- Details on test material:
- - Name of test material (as cited in study report:GLYPHO
- Substance type: Yellowish liquid
- Physical state: Liquid
- Lot/batch no.:AH2/170
- Expiration date of the lot/batch:01-Feb-2002
- Storage condition of test material:In the original container, in the refrigerator (range of 2-8 degrees C), away from direct sunlight.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:Elevage Scientifique des Dombes
F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 10-11 weeks (female number 74 only)
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance ad libitum (batch no. 92/01)
- Water (e.g. ad libitum):Community tap water from Fullinsdorf, ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):17-23 degrees C
- Humidity (%):30-70%
- Air changes (per hr):10-15
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From:19 November 2001 To: 23 November 2001
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 per animal.
- Concentration (if solution): NEAT
VEHICLE
- Amount(s) applied (volume or weight with unit):None - Duration of treatment / exposure:
- Single application with planned observations at 24, 48, and 72 hours.
- Observation period (in vivo):
- As the test article was suspected to produce irritancy a single animal (female number 74) was treated first. The animal was examined at 1 and 24 hours after instillation and severe ocular irriation was observed. Based on these findings the animal was prematurely sacrificed on test day 4 and the remaining two animals were not treated.
- Number of animals or in vitro replicates:
- 3; experiment terminated for humane reasons with only one animal treated.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- ca. 2 - ca. 3
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- A possible reversibility of the corneal opacity was not expected, therefore, the test item can be considered to possess a corrosive potential.
Any other information on results incl. tables
Eye reactions consisted of grade 3.00 corneal opacity, grade 2.00 iris lesions, grade 0.00 redness of the conjunctivae and grade 2.00 chemosis of the conjunctivae. Opacity, affecting the whole area of the cornea, was observed in the treated eye at 1-hour reading and was still evident at termination of the test. Light reflex was absent throughout the 72 hour observation period.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information
- Conclusions:
- Based on the results of this study and the calculated pH (1.72 in 10% solution), the test article is an ocular corrosive.
- Executive summary:
The primary eye irritation/corrosion potential of the test article was evaluated in New Zealand White Rabbits. This study was conducted in compliance with Swiss GLP (2000) and OECD GLP (1997). The test method was based on OECD 405 (1987) and Directive 92/69 EEC, B.5 (1992). Only 1 female rabbit was initially tested as the test article was suspected to produce irritancy. At a concentration of 10% test article in water, the pH was found to be 1.72. The test material (0.1 mL) was administered as received to the conjunctival sac of one eye of the rabbit by gently pulling the lower eyelid away from the eye. The lids were held together for approximately one second after administration to insure adequate distribution of the test material. The contralateral eye of the animal served as the control. The treated eye of the rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours postdose using the Draize technique. Sodium fluorescein dye procedures were not used to improve the evaluation of the cornea. Body weight was recorded at pretest, the day of treatment, and at termination. Ocular discharge was not scored, thus professional judgment was used to score discharge. There were no signs of systemic toxicity or abnormal changes in body weight. The individual mean values (24-72 hours) were 3.0 for corneal opacity, 2.0 for iritis, 0.0 for conjunctival redness, and 2.0 for conjunctival chemosis. Since corneal opacity was not expected to clear, the animal was euthanized in extremis on Day 4, and the other two animals were not treated with the test article. The light reflex was absent throughout the 72-hour observation period. Moderate watery discharge (score: 2) and slight watery discharge (scores: 1) were observed at 1 hour postdose and at 24, 48, and 72 hours postdose, respectively. The highest Primary Irritation Index was 80/110 at 1 hour postdose. No corrosion of the cornea was observed. However, since corneal opacity was not expected to reverse,The test article can be considered to possess a corrosive potential. Based on the results of this study and the calculated pH (1.72 in 10% solution), the test article is an ocular corrosive.
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