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EC number: 942-925-0 | 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study under GLP cpndition
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Azo zinc complex pigment - melamine compound
- IUPAC Name:
- Azo zinc complex pigment - melamine compound
- Test material form:
- other: brown powder
- Details on test material:
- Molecular weight 615.79
Lot no.BOS3479-3105
purity/content: 100 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 3 month
- Weight at study initiation: 2013.3 - 2139.3 g (females)
- Housing:
- Diet ad libitum
- Water ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated right eye served as control
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- up to 72 hours
- Observation period (in vivo):
- up to 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The test substance was applied as a volume of 0.1 g/animal. the dose specified in the test guidelines for test substances. The eyes of the animals were examined one day prior to test substance administration.. On the day of treatment the test substance was applied into the concunctival sac of the left eye of each animal; then the lids were gently held together for about one second to prevent loss of the test substance. The right eye remained untreated and served as the reference control.
A single animal was treated first . As neither a corrosive effect nor a severe irritant effect was observed after the examinations the test was completed using the remaining animals.
The animals were observed in intervals for ui to 72 hours for clinical signs, mortality, changes in body weight and irritation effects on conjunctiva , iris, cornea and chemosis. Evaluation according to Draize 1944: J Pharmacol Exp Ther 82, 377-390
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: during the total observation period
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no corneal opacity
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: during the total observation period of 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: up to 24 hours post treatment
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: some blood vessels hyperemic
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: from 24 hours up to 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects observed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: some swelling above normal
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: from 1 hour up to 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects observed
- Irritant / corrosive response data:
- after application of the test substance slight conjunctival redness (sore 1) and some chemosis above normal (score 1) was observed, but these effects were fully rversible within 48 hours.
- Other effects:
- no mortality, no clinical signs and all tested animals showed normal gains in body weight
Applicant's summary and conclusion
- Executive summary:
The acute eye irritation potential of Azo zinc complex pigment - melamine compound was investigated in 3 rabbits according to OECD TG 405 under GLP conditions. 100 mg of the test substance was applied into the conjunctival sac of the left eye of each of the 3 rabbits . The respective right eye served as control. The animals were observed in intervals up to 72 hours post application for clinical signs, mortality, body weight development and the treated eyes for effects on conjunctiva, cornea and iris.
No mortality was observed, no clinical signs related to treatment were noted; all animals showed normal gains in body weight. No corrosive effects were noted on the treated eye of any animal at any of the measuring intervals. No effects on iris and cornea were seen . Some hyperemic blood vessels (conjunctival injections, score 1) and some swelling above normal (score 1) was seen in each left eye of each of the 3 rabbits. But these effects were fully reversible within 48 hours
Based on these results Azo zinc complex pigment - melamine compound has to be evaluated as slightly irritating to the eyes which do not lead to classification or labelling
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