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EC number: 452-810-2 | 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:
- 2004-03-23 to 2004-04-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Well documented GLP study performed according to the OECD Guideline 405 and the EC test method B.5.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
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
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): T002251
- Physical state: brown powder
- Analytical purity: 96%
- Lot/batch No.: 00410155
- Expiration date of the lot/batch: 2004-05-05
- Storage condition of test material: at room temperature (range of 20 +/-3°C), light protected
- pH: before study initiation: A formulation of 1% in water was prepared. The pH was found to be 5.
- stability of test item: stable under storage conditions
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 treatment: 14-15 weeks (male), 15-16 weeks (females)
- Weight at day of treatment: 2.592 - 2.986 kg
- Fasting period before study: no data
- Housing: standard laboraotry conditions, individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks were provided for gnawing.
- Diet (e.g. ad libitum): ad libitum , pelleted standard Provimi Kliba 3418 rabbit maintenance diet
- Water (e.g. ad libitum): ad libitum , community tap water from Füllinsdorf
- Acclimation period: at least 6 days, under laboraotry conditions after health examination. Only animals without any visual signs of illness were used for the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
- Other: Music was played during the daytime light period
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye remained untreated and served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g , weighed and applied undiluted as it was delivered by the Sponsor - Duration of treatment / exposure:
- single dose, unlimited exposure
- Observation period (in vivo):
- The eyes of each animal were examined approximately 1, 24, 48, 72 hours and 7 days after instillation.
Viability/mortality and clinical signs were assessed daily.
Individual body weights were recorded at start of acclimatization, on the day of application and at termination of observation - Number of animals or in vitro replicates:
- 3 (1 male number 37, 2 females number 38, 39)
As it was suspected that the test item might produce irritancy , a single female animal was treated first. As neither a corrosive effect nor a severe irritant effect was observed after the 1-hour and 24-hour examinations, the test was completed using the two remaining animals. - Details on study design:
- REMOVAL OF TEST SUBSTANCE: the eyes were not rinsed after instillation
TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp (Roth AG, CH-4153 Reinach/Switzerland)
SCORING SYSTEM: The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/89/EEC, July 31, 1992 at approx 1, 24, 48 and 72 hours, as well as 7 days after instillation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 37
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 37
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable - score 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 37
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 37
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 38
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 38
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable - score 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 38
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 38
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 39
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 39
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable - score 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 39
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 39
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Irritant / corrosive response data:
- No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals. Slight reddening of the conjunctivae was observed in all animals from the 1-hour reading up to 48 hours after treatment. Slight swelling (chemosis) was noted in all animals at the 1-hour examination. Moderate reddening of the sclerae was visible in all animals at the 1-hour reading. Slight reddening of the sclerae was observed in all animals 24 hours after treatment and persisted in one animal up to the 72-hour reading. Slight ocular discharge was evident in one animal 1 hour after treatment.
No corrosion of the cornea was observed at any of the reading times.
The individual mean scores for corneal opactiy and iris were 0 for all three animals. The individual mean scores for the conjunctivae were 0.67 for reddening and 0 for chemosis for all three animals. The effect on the conjunctivae was reversible. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. The body weights of all rabbits were considered to be within the normal range of variability.
No staining of the treated eyes produced by the test item was observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the substance T002251 is considered to be not irritating to the rabbit eye and therefore does not need to be classified.
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