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Diss Factsheets
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EC number: 943-109-7 | 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, other
- Remarks:
- points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Acid Red 423
- IUPAC Name:
- Acid Red 423
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Age: 12-14 weeks
Body weight: 2 -3 kg
Source: Kelintierfarm Madoerin AG, Fuellinsdorf CH
Acclimation: 5 days
Accomodation: Caged singly in metal cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret Gmbh, Emmendingen FRG
Temperature of 17-23 °C and with a humidity of 30-70%
Animals were exposed to artificial light for 12 hours daily
Diet: Nafag n. 814 (Gossau, CH) was fed ad libitum. The food was analysed and the results of contaminats are attached to the study report.
Water: community tap water
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye serves as control
- Amount / concentration applied:
- 0.1 g of the test substance
- Duration of treatment / exposure:
- eye lids close for 1 seconds
- Observation period (in vivo):
- up to 7 days
- Number of animals or in vitro replicates:
- 3 males
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 24-72 hours all animals
- Time point:
- other: 24-72 hours
- Score:
- 1.33
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24-72 hours
- Score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24-72 hours
- Score:
- 1.33
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- The tested substance ahowed a primary irritation score of:
1.33 for cornea
1 for iris
2 for conjunctivae redness
1.33 for conjunctivae chemosis
when applied to the rabbit eye mucosa.
The effect was not reversible in 21 days except for chemosis which is fully reversible within 14 days.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- OECD GHS
- Conclusions:
- The tested substance needs to be considered irritant for rabbits eyes under Regulation CE 1272/2008.
- Executive summary:
The ocular reactions were determined followign OECD 405.
The tested substance is considered to be irritant for the rabbits eyes based on the results needs to be classified as H319, Causes serious eye irritation under Regulation 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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