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Diss Factsheets
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EC number: 435-940-4 | 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:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- other: fine dust
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Source: S&K-LAP Kft. 2173 Kartal, Császár út 135, Hungary
Number of animals: 3 animals.
Age of animals at treatment: ~11 weeks old (adult).
Sex: Male.
Body weight range at the beginning of the life phase: 2616 – 2763 g, end of the life phase: 2653 – 2790 g.
Acclimatization time: 5 days.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature during the study: 20 ± 3°C.
Relative humidity during the study: 30 – 70 %.
Housing/Enrichment: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.
Ventilation: 15-20 air exchanges/hour
Feeding: UNI diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum.
Water: Municipal tap water, as for human consumption, ad libitum.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- A single dose of 0.1 g of the solid test item was administered to each animal.
- Duration of treatment / exposure:
- Single dose.
The eyes of the test animals were washed out at 1 hour after application of test item. - Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after treatment.
- Number of animals or in vitro replicates:
- Three.
- Details on study design:
- An initial test was performed using one animal. The test item was instilled into the conjunctival sac of the left eye. The eyelids were held closed for a few seconds to prevent the loss of the test item. The contra lateral eye served as the control. Immediately after the administration of the test item, an assessment of the initial pain reaction was made according to a six point scale. After consideration of the ocular responses produced in the first animal, one hour after the treatment of the first animal, two additional animals were treated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 to 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 to 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 to 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Initial Pain Reaction (IPR) (score 1 or 2) was observed in all animals.
One hour after the application, conjunctival redness (score 1 or 2), discharge (score 1 or 2) were seen in all rabbits.
At 24 hours after treatment conjunctival redness (score 1) was seen in all rabbits.
At 48 and 72 hours after treatment, no signs of eye irritation or other clinical signs were observed. - Other effects:
- MORTALITY: There was no mortality observed during the study.
BODY WEIGHTS: The body weight and body weight change were considered to be normal with no indication of a treatment related effect.
GENERAL CLINICAL OBSERVATION: There were no clinical signs observed that could be related to treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test item caused conjunctival irritant effects at one hour which were reduced at 24 hours after application. The effects were fully reversible within 48 hours.
According to Regulation (EC) No 1272/2008, the substance does not require classification as an eye irritant. - Executive summary:
An acute eye irritation study of the test item was performed in New Zealand White rabbits. The irritation effects of the test item were evaluated according to the OECD method 405, 2002.
The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. An amount of 0.1 g of the test item was administered as a single dose.
Individual body weight was recorded at the beginning and end of the study. Morbidity and clinical signs of toxicity were checked daily. The eyes were examined at 1, 24, 48 and 72 hours after the application.
Results:
Initial Pain Reaction (IPR) (score 1 or 2) was observed in all animals.
One hour after the application, conjunctival redness (score 1 or 2), discharge (score 1 or 2) were seen in all rabbits.
At 24 hours after treatment conjunctival redness (score 1) was seen in all rabbits.
At 48 and 72 hours after treatment, no signs of eye irritation or other clinical signs were observed.
As all signs of eye irritation had fully reversed the study was terminated after a period of 72 hours observation.
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
According to Regulation (EC) No 1272/2008, the substance does not require classification as an eye irritant.
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