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Diss Factsheets
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EC number: 947-285-6 | 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The test was conducted by means of Read Across approach. Further information was attached at section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 79/381, annex V, Part B
- GLP compliance:
- no
Test material
- Reference substance name:
- Acid Brown 360:1 - Similar Substance 01
- IUPAC Name:
- Acid Brown 360:1 - Similar Substance 01
- Test material form:
- not specified
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG CH 4414 Fuellinsdorf I Switzerland
- Age at study initiation: l4 - 15 weeks
- Weight at study initiation: 2.5 - 2.8 Kg
- Housing: housed individually in stainless steel cages equipped with an automatic cleaning and drinking system
- Diet: The diet consisted of pelleted standard Kliba #341 rabbit maintenance diet, Batch 92/83 ad lihitum.
- Water: Tap water ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 - 15 air changes per hour.
- Photoperiod: 12 hour cycle dark/light with artificial fluorescent light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied : 0.1 g
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 2 male and 1 female
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: not rinsed eye
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: not rinsed eye
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: not rinsed eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: #1 and #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: not rinsed eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: not rinsed eye
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 hour
- Remarks on result:
- other: not rinsed eye
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hour
- Remarks on result:
- other: not rinsed eye
- Other effects:
- In the area of application a brown discoloration of the conjunctivae which could be related to effects of the teat article was observed during the observation period.
TOXIC SYMPTOMS / MORTALITY
No acute toxic aymptoma were observed in the animals during the teat period, and no mortality occurred.
NECROPSY
Due to the reaults obtained, no macroscopic organ examination was indicated.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- The substance is not irritating for rabbit eyes.
- Executive summary:
The substance has been tested for eye irritation according to the OECD guideline 405 and EEC Directive 79/381, annex V, Part B. During the test 2 male and 1 female rabbits are treated with 0.1 g of the test compound.
Mean values at 24, 48 and 72 hours corneal opacity were 0.00 in two animals (#1 and #2) and 0.67 in one animal (#3). Mean values at 24, 48 and 72 hours for iris were 0.00 in all three animals. The conjunctivae scores as mean values at 24, 48 and 72 hours were: for redness 0.67 in animals #1 and #3 and 1 in animal #2; for chemosis 0.33 in animal #1 and 1 in animals #2 and #3. All effects observed were fully reversible within the end of the 72 -hour study period, except in one animal (animal #2 showed a redness score 1 at 72 hours). None of the treated eyes was rinsed after the test item application. Moreover, the substance is a powder and thus it is even more necessary to rinse the eye in order to exclude any effects that could occur due to its physical state. In addition, a fully reversibility was observed within 72 hours in all animals besides one animal (#2). Therefore, it is reasonable to expect that reversibility within 21 days will occur also in animal #2 even if it a fully reversibility was not possible to be observed within the 72 hours study period.
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