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EC number: 428-570-1 | CAS number: 187585-64-4
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Physical state: powder / grey-white
- Analytical purity: 95.8% (per weight; HPLC)
- Lot/batch No.: ZD 1151/ 31 (production: 03-Dec-1997)
- Storage condition of test material: refrigerator, protected from light.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG / Chbb: NZW (SPF)
- Age at study initiation: young adult animals
- Weight at study initiation: 3.51 and 3.72 kg for the 2 females, 3.58 kg for the male
- Housing: The animals were single-housed in fully air-conditioned rooms in Stainless steel wire mesh cages with grating, floor area: 3000 cm2; animal identification: ear tattoo. No bedding in the cages; wood shavings in the waste trays.
- Diet, ad libitum: Kliba-Labordiaet, Klingentalmuehle AG Kaiseraugst, Switzerland, (about 130 g per animal per day). The feed used in the study was assayed for chemical and microbiological contaminants. In view of the aim and duration of the study the contaminants occurring were seen as not likely to influence the results.
- Water, ad libitum: about 250 ml tap water per animal per day. The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the technical services of BASF Aktiengesellschaft as well as for the presence of germs by a contract laboratory. In view of the aim and duration of the study the contaminants occurring were seen as not likely to influence the results.
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Central air-conditioning guaranteed a range of 20 - 24 degrees
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12 hours (6.00 am - 600 pm/ 6.00 pm - 6.00 am)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (about 30 mg of the comminuted test substance) - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- up to 28 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes; the substance was washed out with tap water about 24 hours after application (before 24 hour reading).
- Time after start of exposure: 24 hours
SCORING SYSTEM: according to OECD guideline 405 (adopted February 24, 1987) and EEC directive 92/69, L 383A, B.5 (December 29, 1992).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- cornea opacity
- Basis:
- mean
- Remarks:
- from animal #1 and animal #3 (all female)
- Time point:
- other: 24-48-72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Remarks:
- cornea opacity
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: 24-48-72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 days
- Remarks on result:
- other: observed from 48 hours after treatment
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- from animal #1, #2 and #3
- Time point:
- other: 24-48-72 hours
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 days
- Remarks on result:
- other: positive response observed in one treated animal
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1 and animal #3
- Time point:
- other: 24-48-72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 hours
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: observed from 24 hours after treatment
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1, #2 and #3
- Time point:
- other: 24-48-72 hours
- Score:
- 0.2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: positive response observed in only one treated animal
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- animals #1 and 2
- Time point:
- other: 24-48-72 hours
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: scores after 1 hour: 1/2 (animal #1/animal #2); 24 hours: 2/2; 48 hours: 1/1; 72 hours: 1/1; 7 days: 0/1; and 14 days: 0/0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: 24-48-72 hours
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: scores after 1 hour: 1; 24 hours: 2; and 48 hours: 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- from animals #1, #2 and #3
- Time point:
- other: 24-48-72 hours
- Score:
- 1.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: scores (animal #1/animal #2/animal #3) observed after 1 hour: 1/1/1; 24 hours: 0/2/1; 48 hours: 0/1/0; 72 hours: 0/1/0; and 7 days: 0/0/0;
- Other effects:
- conjunctiva discharge was observed in animal #3 after 24 hours (score: 1) and in animal #2 after 1 hour (1), 24 hours (2), 48 hours (1) and 72 hours (1). No other adverse effects were observed
Any other information on results incl. tables
One animal still had corneal opacity grade 1 after 21 days but was free of symptoms after 28 days. The other 2/3 animals were free of symptoms after 7 days and did not show any corneal opacity at any time.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- One animal still had corneal opacity grade 1 after 21 days but was free of symptoms after 28 days. The other 2/3 animals were free of symptoms after 7 days and did not show any corneal opacity at any time.
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