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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 256-851-5 | CAS number: 50925-42-3
- 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- After gently pulling the lower lid away from the eyeball a volume of 100 µl of the pulverized test substance - equivalent to approx. 45 mg - was placed into the conjunctival sac of one eye of each of three rabbits. The lids were then gently held together for about one second in order to limit loss of the material. The other eye remained untreated and served as control. 24 hours after instillation of the test substance the treated eye was rinsed with saline and scored according to Draize.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetrasodium 3,3'-[[6-[(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]bis[imino(2-methyl-4,1-phenylene)azo]]bisnaphthalene-1,5-disulphonate
- EC Number:
- 256-851-5
- EC Name:
- Tetrasodium 3,3'-[[6-[(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]bis[imino(2-methyl-4,1-phenylene)azo]]bisnaphthalene-1,5-disulphonate
- Cas Number:
- 50925-42-3
- Molecular formula:
- C39H30N10Na4O13S4
- IUPAC Name:
- tetrasodium 3,3'-({6-[(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl}bis[imino(2-methyl-4,1-phenylene)diazene-2,1-diyl])dinaphthalene-1,5-disulfonate
Constituent 1
- Specific details on test material used for the study:
- State of Aggregation: solid
External Appearance: yellow-brown powder
contents: 100%
pH: 6-7 (40 g/L H20)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species and species justification
The study was conducted on rabbits an animal species recommended in the guidelines for this type of study.
Healthy adult albino rabbits, strain HC:NZW were used. The health of the animals was routinely examined for the main specific pathogens by the breeder. No vaccinations or treatment with antibiotics were perf'ormed prior to receipt of' the animals or during the acclimatization phase or study period.
Housing and feeding conditions
The rabbits were individually housed in stainless steel cages with flat rod bases or plastic cages with perforated bases, under standardized conventional conditions. Excrement trays beneath the cages contained low-dust (wood) bedding. Bedding was regularly spot-checked for contaminants at the instance of the Department of Laboratory Animal Services, and changed at least twice weekly.
Identification of animals: The rabbits were identified by individual ear marks (tattoos) and cage cards.
Acclimatization:
Prior to the initiation of the treatment the animals were kept for at least 14 days in the quarantine station of the Department of Laboratory Animal Services and monitored for diseases. During this period pooled faeces specimens were examined for Coccidia oocysts.
Animal housing conditions:
All the animals in this study were kept in one room.
Climatic conditions in animal room:
The environmental conditions were adjusted as follows:
Room temperature: 20 ± 3 °C
Humidity, relative: approx. 50 %
Light-/Dark cycle: 12 hours, artificial illumination
Air exchange rate: approx. 10 times per hour
Nutrition:
Feed: Standard diet "Ssniff K 411 (Ssniff Spezialdiäten GmbH, Soest), approx. 100 - 120 g per animal/day; once per day in the morning.
Water: Tap water; ad libitum.
Drink-water was supplied either in polycarbonate bottles containing approx. 750 ml or from automatic watering.
Weight of animals
The animals were weighed immediately before application of the test substance.
Randomization
Rabbits were randomly assigned to the respective treatment groups.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- A volume of 100 µl of the pulverized test substance - equivalent to approx. 45 mg - was placed into the conjunctival sac of one eye.
- Duration of treatment / exposure:
- 24 hours after instillation of the test substance the treated eye was rinsed with saline.
- Observation period (in vivo):
- 7 days.
- Number of animals or in vitro replicates:
- 3 animals.
- Details on study design:
- Procedure
After gently pulling the lower lid away from the eyeball a volume of 100 µl of the pulverized test substance - equivalent to approx. 45 mg - was placed into the conjunctival sac of one eye of each of three rabbits. The lids were then gently held together for about one second in order to limit loss of the material. The other eye remained untreated and served as control. 24 hours after instillation of the test substance the treated eye was rinsed with saline.
Clinical observations and scoring
Eye irritation was scored and recorded at 1h, 24h, 48h, 72h, 7d. The signs of cornea (opacity and area affected), iris (hyperaemia, reaction to light), conjunctivae i.e. conjunctiva of bulbus, lids, and nictitating membrane - (erythema, chemosis), and discharge were recorded as described by DRAIZE, and the aqueous humour (opacity). In addition any serious lesions or toxic effects other than ocular ones were recorded. The examinations of cornea, iris and aqueous humour were facilitated using optical instruments (e.g. hand slit-lamp). To define epithelial damage, one drop of a 1 % fluorescein solution was applied to the corneal surface 24 hours after administration of the test substance; where positive effects were recorded this was repeated at the later observation times. The eye was then rinsed with saline to remove excess and nonabsorbed fluorescein. Evaluation was performed by means of ultraviolet illumination (area) in a darkened room and diffuse white illumination.
Evaluation of results
Only effects persisting for more than 24 hours were included in the evaluation. The irritation indices / mean irritation indices were calculated for cornea (degree of opacity), iris, erythema and swelling (chemosis) of the conjunctivae.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.77
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritant / corrosive response data:
- Exposure of the test substance to the eye caused slight erythematous reactions of the mucous membranes. These reactions which were only transiently evident in one animal remained apparent in another animal up to 72 hours following instillation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Exposure of the test substance to the eye caused slight erythematous reactions (mean score = 0.77 at 24,48, and 72 hours) of the mucous membranes. These reactions which were only transiently evident in one animal remained apparent in another animal up to 72 hours following instillation.
- Executive summary:
A study according to OECD guideline 405 was conducted. After gently pulling the lower lid away from the eyeball a volume of 100 µl of the pulverized test substance - equivalent to approx. 45 mg - was placed into the conjunctival sac of one eye of each of three rabbits. The lids were then gently held together for about one second in order to limit loss of the material. The other eye remained untreated and served as control. 24 hours after instillation of the test substance the treated eye was rinsed with saline and scored according to Draize. Exposure of the test substance to the eye caused slight erythematous reactions (mean score = 0.77 at 24,48, and 72 hours) of the mucous membranes. These reactions which were only transiently evident in one animal remained apparent in another animal up to 72 hours following instillation.
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.