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Reaction mass of pentasodium 2-{[4-chloro-6-(ethyl{3-[(2-sulfonatoethyl)sulfonyl]phenyl}amino)-1,3,5-triazin-2-yl]amino}-5-hydroxy-6-({2-sulfonato-4-[(4-sulfonatophenyl)diazenyl]phenyl}diazenyl)naphthalene-1,7-disulfonate and tetrasodium 2-[(4-chloro-6-{ethyl[3-(vinylsulfonyl)phenyl]amino}-1,3,5-triazin-2-yl)amino]-5-hydroxy-6-({2-sulfonato-4-[(4-sulfonatophenyl)diazenyl]phenyl}diazenyl)naphthalene-1,7-disulfonate
EC number: 459-580-2 | 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
- Study period:
- 25 January 2006 to 02 March 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 2004/73/EC, B-5, "Acute Toxicity; Eye Irritation/Corrosion", April 29, 2004.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- -Batch No.: ROE 805 BOP 04/05
-Colour: Dark red
-Solubility in water: >100g/L at 20 °C
-Solubility in vehicle: Miscible
-Stability in solvent: 7 days in Water, Saline, Polyethylene Glycol, Carboxymethylcellulose, and 1 day in Vaseline and FCA at room temperature.
-Storage: At room temperature, in the desicator
-Expiration Date: October 01, 2010
-Purity: Approx. 82 % organic part (Na-salt),
all coloured components = 80.3 %;
Main component 1: 36.2 %,
Main component 2: 27.5 %, Oligomers: 10 %
Constituent 1
- Specific details on test material used for the study:
- Identity: FAT 40824/A
Batch: Red ROE 805 BOP 04/05
Appearance: dark red powder
Purity: Organic part (Na-salt): approx. 82 %; Main component 1 : approx. 36.2 %; Main component 2: approx. 27.5 %; Oligomers: 10%
Expiration date: 01 October 2010
Storage: At room temperature at about 20°C in a desiccator (hygroscopic)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
Test system: Young Adult New Zealand White Rabbit, SPF
Source: Charles River Deutschland GmbH Stolzenseeweg 32-36 D-88353 Kisslegg / German
Age at treatment: 13-14 weeks (male), 12 weeks (females)
Acclimatization: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
Accommodation: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4642 (batch no. 57/05, Provimi Kliba AG) were provided for gnawing.
Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 74/05) provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Results of analysis for contaminants are archived at RCC Ltd.
Water: Community tap water from Füllinsdorf, ad libitum.
Allocation: Male No. 33, Female Nos. 34 and 35
ENVIRONMENTAL CONDITIONS
Air-conditioned with ranges for room temperature 17-23 relative humidity 30-70 % and approximately 10-15 air changes per hour. Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room cleaning. These transient variations are considered not to have any influence on the study and, therefore, these data are not reported but are retained at RCC. The animals were provided with an automatically controlled tight cycle of 12 hours light and 12 hours dark. Music was played during the daytime light period.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g (per animal)
- Duration of treatment / exposure:
- one second
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after administration
- Number of animals or in vitro replicates:
- Number of animals per test: 3 (animals of both sexes were used)
- Details on study design:
- TEST ITEM PREPARATION
0.1 g (per animal) of FAT 40824/A was weighed and applied undiluted as it was delivered by the Sponsor. The eyes of the animals were examined one day prior to test item administration.
TREATMENT
Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test.
On the day of treatment, 0.1 g of FAT 40824/A 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 hefd together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation.
Observations
viabilily/Mortality and Clinical signs: Daily from acclimatization of the animals to the termination of test.
body weights: At start of acclimatization, on the day of application and at termination of observation
Irritation scores:The eyes of each animal were examined approximately 1, 24, 48, 72 hours and 7, 10, 14, 17 and 21 days after administration.
No necropsy was performed on the animals sacrificed at termination of observation. All rabbits were sacrificed by an intravenous injection of Vetanarcol into the ear vein at a dose of at least 1 mL/kg body weight (equivalent to 162 mg sodium pentobarbitone/kg body weight) and discarded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals.
Slight reddening of the conjunctivae was noted in alt animals at the 1-hour observation and persisted in one animal until the 24-hour observation.
Slight swelling (chemosis) of the conjunctivae was observed in one animal at the 1-hoar observation.
Marked red staining prevented the assessment of the sclerae in one animal at the 1-hour reading and slight reddening of the sclerae was present in the two remaining animals at the 1-hour observation and persisted in one animal at the 24-hour reading.
No abnormal findings were observed in the treated eye of any animal 43 hours after treatment, the end of the observation period for all animals.
No corrosion of the cornea was observed at any of the reading times. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
Slight to marked red staining of the treated eyes was observed in all animals one hour after treatment and persisted as slight staining until the 72-hour, 7-day or 21-day observation, respectively.
The body weights of all rabbits were considered to be within the normal range of variability.
Any other information on results incl. tables
Individual eye score:
Animal No. |
Time point |
Corneal opacity |
Area of Corneal Opacity |
Iris |
Conjunctiva |
Sclera |
|
|
Redness |
Chemosis |
|||||
33 |
After 24 h |
0 |
0 |
0 |
0 |
0 |
0 |
34 |
0 |
0 |
0 |
1 |
0 |
0 |
|
35 |
0 |
0 |
0 |
0 |
0 |
1 |
|
33 |
After 48 h |
0 |
0 |
0 |
0 |
0 |
0 |
34 |
0 |
0 |
0 |
0 |
0 |
0 |
|
35 |
0 |
0 |
0 |
0 |
0 |
0 |
|
33 |
After 72 h |
0 |
0 |
0 |
0 |
0 |
0 |
34 |
0 |
0 |
0 |
0 |
0 |
0 |
|
35 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the study, FAT 40824/A is non-irritant to the eye of rabbits.
- Executive summary:
In a GLP compliant study, the primary eye irritation potential of FAT 40824/A was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7, 10, 14, 17 and 21 days after test item instillation.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and Chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00, 0.33 and 0.00 for reddening and 0.00 for Chemosis for all three animals.
The instillation of FAT 40824/A into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae and Chemosis. These effects were reversible and were no longer evident 48 hours after treatment. Slight to marked red staining of the treated eyes was observed in all animals one hour after treatment and persisted as slight staining until the 72-hour, 7-day or 21-day observation, respectively. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No clinical signs were observed. Thus, the test item did not induce significant damage to the rabbit eye.
Based on the study results, FAT 40824/A does not have to be classified and labelled as 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.
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