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EC number: 272-939-6 | CAS number: 68921-42-6
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the cumulative (repeated application) eye irritation and corneal staining potential of FD and C Yellow No. 5, FD and C Blue No. 1 and FD and C Blue No. 1 Aluminum Lake
- Author:
- S.D. Gettings, D.L. Blaszcak, M.T. Roddy, A.S. Curry and G.N. McEwen Jr
- Year:
- 1 992
- Bibliographic source:
- Food and Chemical Toxicology (1992), 30(12), 1051-1055.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize test
- Principles of method if other than guideline:
- Ocular irritation was determined according to a modification of the Draize test (Draize, 1959). Test material (3%,wt./vol. in aqueous vehicle) was administered once daily, for a total of 21 days, to the conjunctival sac of the right eye of New Zealand White rabbits.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dihydrogen (ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, aluminium salt
- EC Number:
- 272-939-6
- EC Name:
- Dihydrogen (ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, aluminium salt
- Cas Number:
- 68921-42-6
- Molecular formula:
- C37H36N2O9S3.xAl
- IUPAC Name:
- Dihydrogen (ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, aluminium salt
- Test material form:
- solid
- Details on test material:
- - Name of test material : Dihydrogen (ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, aluminium salt
Commen name:FD&C Blue No. 1 aluminum lake
- Molecular formula:C37H36N2O9S3.xAl
- Molecular weight : 775.8764 g/mol
- Smiles notation :c1(ccccc1/C(=C/1C=C/C(=[N+](\CC)Cc2cc(ccc2)S(=O)(=O)[O-])C=C1)c1ccc(cc1)N(CC)Cc1cc(ccc1)S(=O)(=O)O)S(=O)(=O)O
- InChl 1S/C37H36N2O9S3.Al/c1-3-38(25-27-9-7-11-33(23-27)49(40,41)42)31-19-15-29(16-20-31)37(35-13-5-6-14-36(35)51(46,47)48)30-17-21-32(22-18-30)39(4-2)26-28-10-8-12-34(24-28)50(43,44)45;/h5-24H,3-4,25-26H2,1-2H3,(H2-,40,41,42,43,44,45,46,47,48);
- Substance type : Organic
-Batch No.: FG/16-17/0204
- Physical state: Solid powder (Blue)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.0-3.5 kg
- Housing: individually housed in stainless steel, wire mesh-floor cages.
- Diet (e.g. ad libitum): Certified Lab Rabbit Chow HF; Purina No. 5325 ;ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-21°C
- Humidity (%): 38%
- Photoperiod (hrs dark / hrs light): 12-hr light/dark cycle
Test system
- Vehicle:
- other: test substance was prepared daily as a 3% (w/v) suspension in aqueous vehicle containing 0.5% (w/v) hydroxypropyl methylcellulose and 0.25% (w/v) laureth -10 acetate.
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- Test and vehicle control materials (30µl) were administered to the right eye of New Zealand White rabbits
- Duration of treatment / exposure:
- 24 hrs.
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 6 of each sex per group (Total 12)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Ophthalmic observations: 7 days and 24 hr prior to the initial dose, on days 3, 7 and 14 (prior to daily dosing), and at the end of the study.
SCORING SYSTEM: ocular irritation pretest
TOOL USED TO ASSESS SCORE: slit-lamp bimicroscopy (including examinations of fluorescein stain retention to evaluate integrity of the corneal epithelium)
Results and discussion
In vivo
Results
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 21 days
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- All animals survived and were free of significant clinical signs of toxicity throughout the study. Ophthalmoscopic examinations revealed that all animals were free of abnormalities & free of signs of ocular irritation, staining and particle embedment.
- Irritant / corrosive response data:
- All animals were free of significant signs of ocular irritation, staining and particle embedment.
- Other effects:
- All animals survived and were free of significant clinical signs of toxicity throughout the study. Ophthalmoscopic examinations revealed that all animals were free of abnormalities considered to be of clinical importance.
Any other information on results incl. tables
Table 1: Experimental design in evaluation of cumulative eye irritation of the test chemical
Group |
Test material |
No. of animals |
Concentration |
Dose/application |
Applications/day |
No of days |
I |
Control |
12 |
0%* |
30 µl |
1 |
21 |
II |
test chemical |
12 |
3% (w/v) |
30 µl |
1 |
21 |
* Aqueous vehicle containing 0.5% (w/v) hydroxypropyl methylcellulose and 0.25% (w/v) laureth-10 acetate.
Table 2: Scoring scheme for ocular staining
Extent of reaction |
Score |
Intensity |
|
No reaction |
0 |
Barely perceptible (scattered or diffuse areas of staining) |
+ |
Slight (easily discernible stained areas; details of iris clearly visible) |
+ 1 |
Moderate (moderately stained conjunctivae, and/or no details of iris visible; size of pupil barely discernible) |
+2 |
Marked (severely stained conjunctivae, and/or iris not discernible through staining) |
|
Area of cornea involved (I or greater) |
|
One-quarter (or less) but not zero |
1 |
Greater than one-quarter, but less than one-half |
2 |
Greater than one-half, but less than three-quarters |
3 |
Greater than three-quarters, up to whole area |
4 |
Table 3: Summary of ocular effects in evaluation of the (repeated application) eye irritation potential of the test chemical
Group |
Eye |
Observation |
||||
|
|
Test day |
1 |
7 |
14 |
21 |
I - Control |
Test eye |
Conjunctivae |
|
|
|
|
Redness --score of 1 |
- |
- |
- |
- |
||
Discharge--score of 1 |
1 |
- |
1 |
- |
||
I - Control |
Control eye |
Conjunctivae |
|
|
|
|
Discharge – score of 1 |
1 |
- |
1 |
- |
||
Apparent hemorrhage |
- |
- |
- |
1 |
||
test chemical |
Test eye |
Conjunctivae |
|
|
|
|
Redness --score of 1 |
- |
- |
- |
- |
||
Discharge--score of 1 |
- |
- |
- |
1 |
||
test chemical |
Control eye |
Conjunctivae |
|
|
|
|
Redness --score of 1 |
- |
- |
- |
- |
||
Chemosis--score of 1 |
- |
- |
1 |
- |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Conclusions:
- The test chemical when administered once daily, for 21 days, to the conjunctival sac of the right eye of New Zealand White Rabbits at a dose volume of 30 µl showed no significant signs of ocular irritation, staining and particle embedment. All animals survived and were free of significant clinical signs of toxicity throughout the study. Thus it was concluded that the test chemical was not irritating to eyes.
- Executive summary:
Ocular irritation potential of the test chemical was determined according to a modification of the Draize test (Draize, 1959). The test chemical was prepared daily as a 3% (w/v) suspension in aqueous vehicle containing 0.5% (w/v) hydroxypropyl methylcellulose and 0.25% (w/v) laureth -10 acetate. The test chemical (3% w/v in aqueous vehicle) was administered once daily, for a total of 21 days, to the conjunctival sac of the right eye of New Zealand White Rabbits (6 of each sex/ group) at a dose volume of 30µl. Control animals (6 of each sex) received 30/µl of the vehicle daily.Ocular irritation was determined according to a modification of the Draize test (Draize, 1959). Interpretation of observations and assignment of scores were consistent with those described by the Consumer Product Safety Commission (1972).All eyes were scored for ocular irritation pretest (8 days, 24 hr and immediately prior to the initial dose) and approximately 24 hr after each treatment, prior to the next instillation of test material; on days 1, 3, 7, 14 and 21, the eyes were also evaluated for irritation 1 hr after treatment. In addition, all readily observable ocular structures were evaluated for eye stain and particle embedment 24 hr after each treatment. All animals survived and were free of significant clinical signs of toxicity throughout the study Ophthalmoscopic examinations revealed that all animals were free of abnormalities, all animals were free of significant signs of ocular irritation, staining and particle embedment. Thus it was considered that the test chemical was not irritating to eyes.
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