Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 228-768-4 | CAS number: 6358-31-2
- 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: The test was performed in accordance with OECD and GLP guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide
- EC Number:
- 228-768-4
- EC Name:
- 2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide
- Cas Number:
- 6358-31-2
- Molecular formula:
- C18H18N4O6
- IUPAC Name:
- 2-[(2-methoxy-4-nitrophenyl)diazenyl]-N-(2-methoxyphenyl)-3-oxobutanamide
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- - Name of test material (as cited in study report): Hansa Brilliant Yellow 5GX IN
- Common name: C.I. Pigment Yellow 74
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Toxicology Department Rallis Research Centre, Bangalore, India
- Age at study initiation: 4 months
- Weight at study initiation: 2.43-2.66 kg
- Housing: individually in fibreboard cages
- Diet (e.g. ad libitum): Amrut rabbit feed, Nav Maharashta Chakan Oil Mills Ltd, Pune, India, ad libitum
- Water (e.g. ad libitum): purified deep bore well water, ad libitum
- Acclimation period: 7-8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23 °C
- Humidity (%): 30-70 % relative humidity
- Air changes (per hr): adequate fresh air supply
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 14 mg, equivalent to 0.1 ml - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after treatment end
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION OF ANIMALS: The eyes of the rabbits were observed one day prior to the test item instillation for signs of eye irritation, ocular defects or pre-existing corneal injury and as the rabbits were free of all these signs, they were selected for the study.
REMOVAL OF TEST SUBSTANCE
- Washing: after 24 hours, the treated eye was irrigated with deionised water to remove residual test item; the control eye was washed similarly.
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draiz scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: after 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable since no effect
- Remarks on result:
- other: including opacity and area
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable since no effect
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: after 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable since no effect
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0.11
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- One animal showed a grade 1 conjunctival redness at the 24 hour reading. All other readings of conjunctival redness, chemosis, discharge, iris or cornea effects in all three animals at all reading times (1 hour, 24, 48 and 72 hours) were grade 0.
- Other effects:
- No pre-terminal deaths were observed. Body weights of all the rabbits increased during the observation period. No abnormal necropsy findings were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- 67/548/EEC: Eye irritation: no classification warranted
1272/2008/EC: Eye irritation: no classification warranted
In an OECD guidline and GLP compliant eye irritation test in rabbits, a Hansa Brilliant Yellow 5GX IN (Pigment Yellow 74) did only cause very mild, transient signs of eye irritation, but has not to be classified as eye irritant.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.