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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 854-560-3 | CAS number: 1891094-25-9
- 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:
- Experimental 14-12-2016 to 23-12-2016. Final report issued 1-03-2017.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- hexasodium 5,5'-{[2,7-disulfonato-9-(2-sulfonatophenyl)-9H-xanthene-9-ylium-3,6-diyl]bis(azanediyl)bis[(2,4,6-trimethyl-3,1-phenylene)aminosulfonyl]}diisophthalate
- EC Number:
- 854-560-3
- Cas Number:
- 1891094-25-9
- Molecular formula:
- C53H38N4Na6O22S5
- IUPAC Name:
- hexasodium 5,5'-{[2,7-disulfonato-9-(2-sulfonatophenyl)-9H-xanthene-9-ylium-3,6-diyl]bis(azanediyl)bis[(2,4,6-trimethyl-3,1-phenylene)aminosulfonyl]}diisophthalate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The New Zealand White rabbit is one of the standard strains used for acute irritation toxicity studies.
Animal health: Only animals in acceptable health condition were used for the test. Both eyes of each animal provisionally selected for testing were examined prior to starting the study. Animals showing eye irritation, ocular defects or pre-existing cornealinjury were not used.
Number of animals: 3 animals
Age of animals at treatment: 11 weeks old (young adult)
Sex: Male
Body weight range on the day of treatment: 2751 g – 2955 g before euthanasia: 2802 g – 3007 g
Date of receipt: 07 December 2016
Acclimatization time: at least 7 days
Animal identification: The individual identification was by engraved ear tag. The cages were marked with individual identity cards with information about study code, sex, dose, cage number and individual animal number.Animal health: Only healthy animals were used for the test. The veterinarian certified health status.
Number of animal room: 032
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature during the study: 19.54 – 22.53 °C
Relative humidity during the study: 29.56 – 55.82%
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 The temperature and relative humidity values were measured continuously. The measured range was checked at least daily during the acclimatisation and experimental phases.
FOOD AND FEEDING Animals received UNI diet for rabbits produced by Cargill Takarmány Zrt., H-5300 Karcag,Madarasi út 0399, Hungary, ad libitum. Animals were provided with the following batches:
• 0003801145, expiry date: 01 March 2017
• 0003659483, expiry date: 03 January 2017
WATER SUPPLY AND QUALITY CONTROL OF WATER
The animals received municipal tap water, as for human consumption, ad libitum, from an automatic system. The quality control analysis is performed once every three months and microbiological assessment is performed monthly, by Veszprém County Institute of State Public Health and Medical Officer Service (ÁNTSZ, H-8201 Veszprém, József A.u. 36., Hungary). The quality control results are retained in the archives of CiToxLAB HungaryLtd.
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A single amount of 0.125 g of the solid (using the correction factor: 1.25) test item was powdered and administered as a single dose. The test substance was placed in the conjunctival sac of the left eye of each animal after
gently pulling the lower lid away from the eyeball. The lids were then gently held together for at least one second in order to prevent loss of the material. The untreated contralateral eye served as the control. - Duration of treatment / exposure:
- The treated eye of test animals was rinsed with physiological saline solution, as the irritation scores more than one at one hour after application.
- Observation period (in vivo):
- Clinical Observations and Evaluation of Ocular Irritation
The eyes were examined at 1, 24, 48, 72 hours after treatment. The duration of the
observation period was sufficient to identify reversibility or irreversibility of changes. Any
clinical signs of toxicity or signs of ill-health during the study were recorded. At the end of
the observation period, the animal was sacrificed by intramuscular injections of Ketamin
10% (Ketamidor) and Xylazin 2% (Primazin 2%) followed by i.v. pentobarbital sodium (see
details in 3.2.). Death was verified by checking pupil and corneal reflex and the absence of
respiration.
All rabbits were examined for distress at least twice daily, with observations at least 6 hours
apart. Clinical observations or signs of ill-health were recorded. - Number of animals or in vitro replicates:
- 3
- Details on study design:
The treated eye of test animals was rinsed with physiological saline solution, as the irritation scores more than one at one hour after application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- other: redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0 - < 0.33
- Max. score:
- 0.33
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0 - < 0.66
- Max. score:
- 0.66
- Other effects:
- As no clinical signs were observed, the experiment was terminated after 72 hours observation. During the experiment, the control eye of each animal was symptom-free.
The general state and behaviour of animals were normal throughout the study period.
Any other information on results incl. tables
Animal 1 (No: 6290) clinical observation
At 1 and 24 hours after the application, conjunctival redness (score 1) and discharge (score 2) were noted in the rabbit. The test item coloured the hairs to purple around the eye in the animal at 1 hour after the application. At 48 and 72 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.
Animal 2 (No: 6121) clinical observation
At 1 hour after the application, conjunctival redness (score 1) and discharge (score 2) were noted in the rabbit. The test item coloured the hairs to purple around the eye in the animal at 1 hour after the application.
At 24 hours after the application, conjunctival redness (score 1) and discharge (score 1) were noted in the rabbit.
At 48 and 72 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.
Animal 3 (No: 6122) clinical observation
At 1 hour after the application, conjunctival redness (score 1) and discharge (score 2) were noted in the rabbit. The test item coloured the hairs to purple around the eye in the animal at 1 hour after the application.
At 24,48 and 72 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance applied to rabbit eye mucosa, caused conjunctival effects at one and 24 hours after the treatment which were fully reversible within 48 hours.
There were no corneal effects observed in the study.
According to Regulation (EC) No 1272/2008, Dye-2016 does not require classification as an eye irritant.
According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, test substance does not require classification as an eye irritant. - Executive summary:
Introduction
The objective of the study was to determine the acute eye irritation effect of the test item in the New Zealand White Rabbit. The test item was applied as a single dose to the left eye of treated animals. The degree of irritation was scored at specified time intervals.
Results
MORTALITY-There was no mortality observed during the study.
BODY WEIGHTS-The body weight of the animals was considered to be within the normal range of variability.
CLINICAL OBSERVATION
. General daily examination-There were no clinical signs observed that could be related to treatment.
No Initial Pain Reaction/Pain reaction (IPR/PR) was observed
Conclusion
The test substance, applied to rabbit eye mucosa, caused conjunctival effects at one and 24 hours after the treatment which were fully reversible within 48 hours.There were no corneal effects observed in the study.
According to Regulation (EC) No 1272/2008, Dye-2016 does not require classification as an eye irritant.
According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, test substance does not require classification as an 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.