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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 419-720-5 | CAS number: 182061-89-8
- 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:
- 29 June 1995 to 2 July 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, performed to valid guidelines and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 419-720-5
- EC Name:
- -
- Cas Number:
- 182061-89-8
- Molecular formula:
- C25H26N9O12S3 . 3 Na
- IUPAC Name:
- trisodium 6-amino-5-{2-[4-({4-[bis(2-hydroxyethyl)amino]-6-[(2-sulfonatoethyl)amino]-1,3,5-triazin-2-yl}amino)-2-sulfonatophenyl]diazen-1-yl}-4-hydroxynaphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): M-377
- Physical state: solid
- Appearance: garnet powder
- Storage condition of test material: room temperature and protected from light
- pH of substance: 8.3 (measured at a concentration of 10% w/w in distilled water)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: males
- Weight at study initiation: 2.6 ± 0.2 kg (mean)
- Housing: individually in polystyrene cages
- Diet: pelleted diet, ad libitum
- Water: filtered drinking water (0.22 µm), ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
IN-LIFE DATES: From 29 June 1995 to 2 July 1995
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- A single application was performed
- Observation period (in vivo):
- 72 hours following dose administration
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- ADMINISTRATION
- Dose administration: Approximately 100 mg of the test material was applied into the conjunctival sac of the left eye of each rabbit by gently pulling the lower lid away from the eyeball. The lower and upper eyelids were then gently held together for about 1 second to avoid any loss of test material. The right eye was untreated (control eye).
REMOVAL OF TEST SUBSTANCE
- The eyes were not rinsed after administration of the test material.
SCORING SYSTEM
- The reactions observed were scored in accordance with the criteria of Draize (see field "Any other information on materials and methods incl. tables" for further information), at 1, 24, 48 and 72 hours after administration of the test material.
TOOL USED TO ASSESS SCORE: Direct corneal examination was performed, if necessary with an Ultra Violet lamp. 1 or 2 drops of 0.5 % sodium fluorescein solution was used to determine the presence or absence of corneal opacification.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no iridial effects noted throughout study
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no corneal effects noted throughout study
- Irritant / corrosive response data:
- Very slight or slight conjunctival redness (grade 1 or 2) was observed at the 24 hour reading in all animals. Conjunctival redness was masked by a garnet colouration of the conjunctiva one hour after treatment only; in addition, a moderate clear discharge (grade 2) was noted in one animal only. No effects on the iris or cornea were noted. No ocular reactions were observed after the 24 hour reading.
Any other information on results incl. tables
Table 2: Results
Rabbit number |
Region of eye |
Ocular reaction |
Score |
Mean irritation score** |
|||
1 hour |
24 hours |
48 hours |
72 hours |
||||
1 |
Conjunctivae |
Chemosis |
0 |
0 |
0 |
0 |
0.0 |
Redness |
C |
1 |
0 |
0 |
0.3 |
||
Discharge |
0 |
0 |
0 |
0 |
0.0 |
||
Iris |
0 |
0 |
0 |
0 |
0.0 |
||
Corneal opacity |
Intensity |
0 |
0 |
0 |
0 |
0.0 |
|
Area |
0 |
0 |
0 |
0 |
0.0 |
||
Other |
* |
* |
* |
* |
|||
Fluorescein |
/ |
U |
/ |
/ |
|||
2 |
Conjunctivae |
Chemosis |
0 |
0 |
0 |
0 |
0.0 |
Redness |
C |
2 |
0 |
0 |
0.7 |
||
Discharge |
0 |
0 |
0 |
0 |
0.0 |
||
Iris |
0 |
0 |
0 |
0 |
0.0 |
||
Corneal opacity |
Intensity |
0 |
0 |
0 |
0 |
0.0 |
|
Area |
0 |
0 |
0 |
0 |
0.0 |
||
Other |
* |
* |
* |
* |
|||
Fluorescein |
/ |
U |
/ |
/ |
|||
3 |
Conjunctivae |
Chemosis |
0 |
0 |
0 |
0 |
0.0 |
Redness |
C |
1 |
0 |
0 |
0.3 |
||
Discharge |
2 |
0 |
0 |
0 |
0.0 |
||
Iris |
0 |
0 |
0 |
0 |
0.0 |
||
Corneal opacity |
Intensity |
0 |
0 |
0 |
0 |
0.0 |
|
Area |
0 |
0 |
0 |
0 |
0.0 |
||
Other |
* |
* |
* |
* |
|||
Fluorescein |
/ |
U |
/ |
/ |
** = Mean of readings taken at 24, 48 and 72 hours only
C = scoring obscured by garnet colouration
* = None
/ = fluorescein not used
U = fluorescein used
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, the test material only elicited slight reactions in any of the animals during the course of the study that meant the test material does not require classification as an eye irritant. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
- Executive summary:
The eye irritation potential of the test material was determined in accordance with standardised guidelines OECD 405 and EU Method B.5. Approximately 100 mg of test material was applied into one eye of each of three rabbits; the animals were assessed for up to 72 hours to determine the grade of ocular reaction. Very slight or slight conjunctival redness (grade 1 or 2) was observed at the 24 hour reading in all animals. Conjunctival redness was masked by a garnet colouration of the conjunctiva one hour after treatment only; in addition, a moderate clear discharge (grade 2) was noted in one animal only. No effects on the iris or cornea were noted. No ocular reactions were observed after the 24 hour reading. Based on these observation it was determined that the test material in not classified for eye irritation.
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.