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EC number: 473-130-2 | 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:
- From July 07, 2006 to July 10, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD Guideline 405, EPA OPPTS 870.2400 and EU Method B.5, in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- 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:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Reaktiv Rot F99-0078
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ferenc Sandor breeder, 2173 Kartal, Csaszar ut 135, Hungary
- Date of receipt: June 27, 2006
- Age at study initiation: 10 weeks old, adult albino rabbit
- Body weight range at treatment: 2,706-2,838 g (i.e., at the beginning of the study), 2,746-2,908 g (i.e., at the end of the study)
- Sex: Male.
- Housing: Animals were housed individually in metal cages
- Diet: Purina Base – Lap gr. diet for rabbit produced by Agribrands Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum
- Water: Tap water from automatic self-supplying watering system, ad libitum
- Animal health: Only animals in acceptable health condition were used for the test. Both eyes of each animal provisionally selected for testing were examined 24 h prior to the start of study. Animals showing eye irritation, ocular defects or pre-existing corneal injury were not used.
- Acclimation period: 10 d
- Animal identification: The individual identification was performed by numbered ear tag. The cages were marked with individual identity cards with information about study code, sex, dose group, cage number and individual animal number.
ENVIRONMENTAL CONDITIONS
- Temperature: 20±3°C
- Relative humidity: 30-70%
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From: To: July 07, 2006 to July 10, 2006
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral eye
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 24, 48 and 72 h following administration of the test substance.
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- Test Procedure
Three male animals in acceptable health condition were selected for the test. Care was taken to select only those animals that had a normal eye condition, any with ocular lesions were rejected.
In the first step an initial test was performed using one animal. The test substance was instilled into the conjunctival sac of the left eye. The eyelids were held closed gently for several seconds to prevent the loss of the test substance. The contralateral eye served as control. Immediately after the administration of the test substance, an assessment of the initial pain reaction was made.
After consideration of the ocular responses produced in the first animal, two additional animals were treated. Before the administration the treated eyes of animals were not anaesthetised, because the score of initial pain reaction in the first animal indicated practically no initial pain.
Duration of Exposure
The eyes of the test animals were not washed out after the application of test substance.
OBSERVATIONS AND SCORING
Clinical Observations
The eyes were examined at 1, 24, 48 and 72 h after the treatment. The duration of the observation period was sufficient for the statement of reversibility or irreversibility of changes. Any clinical signs of toxicity or signs of ill-health during the study were recorded. At the end of the observation period all animals were sacrificed by intramuscular injections of Ketamin and Xylazin followed by i.v. Euthanyl anaesthesia.
Scoring and Assessment of Local Reaction
The eye irritation scores were evaluated according to the scoring system by Draize (1959) and OECD 405 (24 April 2002).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritant / corrosive response data:
- - 1h after treatment in all animals the vessels were more diffuse, with obvious conjunctival swelling with partial eversion of the lids and the discharge with moistening of the lids and hairs on considerable area around the eye was found.
- Corneal and iris alterations were not recorded throughout the study period.
- 24 h after treatment in all animals displayed some hyperaemic blood vessels. In two animals the discharge from the eye was greater than normal. In one animal some swelling above normal was observed at this time.
- 48 h after treatment every animal was symptom-free.
- 72 h after treatment the study was terminated, since no primary irritation symptoms occurred.
- During the study the control eyes of animals were symptom-free. - Other effects:
- - General state and the behaviour of animals were normal throughout the study period.
- There were no notable body weight changes during the contact and observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test substance was not considered to be irritating to eyes.
- Executive summary:
A study was conducted to assess the eye irritancy potential of the test substance in male New Zealand White rabbits according to OECD Guideline 405, EPA OPPTS 870.2400 and EU Method B.5, in compliance with GLP.
A single dose of 100 mg test substance was applied to the conjunctival sac of the left eye of each animal. The treated eyes were not washed out after admnistration. The untreated eyes served in each case as a control.
Moderate redness, chemosis and severely increased discharge were observed 1 h after the single application. All animals were free of irritation symptoms after 48 h. Further, no corneal and iris alterations were observed throughout the study period. In addition, no clinical signs of systemic toxicity and no notable body weight changes were seen during the study period.
Under the test conditions, the test substance was not considered to be irritating to eyes.
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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