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EC number: 290-924-2 | CAS number: 90294-40-9
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study performed on a similar substance
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- other in vivo test already available
Test material
- Reference substance name:
- Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium
- EC Number:
- 260-394-7
- EC Name:
- Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium
- Cas Number:
- 56819-40-0
- Molecular formula:
- C32H21CrN10O11S.2Na
- IUPAC Name:
- Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:.From the results obtained under the experimental conditions employed, the test article did not provoke any reaction of cutaneous sensitization in the animals examined.
- Age at study initiation:about 6 weeks old
- Weight at study initiation:250 - 550 g.
- Housing:animals housed in groups according to EEC/86/609 in stainless steel mesh cages (internal dimensions 500 x 600 x 200 mm).
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:at least 5 days between animal arrival and start of treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):19 3°C (target values)
- Humidity (%): >=45 % R.H. (target values),
- Air changes (per hr):>=22 air changes per hour,
- Photoperiod (hrs dark / hrs light):12 hours light (artificial)/12 hours dark.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Treated group :
-By intradermal route : 3 series of 2 x 0.1 ml injections
*Freund's complete adjuvant at 50 % (V/V) in an isotonic injectable solution
*test article in a 0.1 % (W/W) solution in water for injection ;
*mixture 50/50 (V/V) : test article in a 0.2 % (W/W) solution in water for injection + Freund's complete adjuvant at 50 % (V/V) in an isotonic injectable solution, i.e. a final 0.1 % concentration of the test article.
During the preliminary study, injection of the test article in a 0.1 % solution tinted the skin of the animals thus making observation of erythema impossible. No oedema was noted.
-By topical occlusive route for 48 hours, with 0.5 ml of the test article in a 56 % (W/W) paste in water for injection.
During the preliminary study, the test article tinted the skin of the animals thus making observation of erythema impossible. Nevertheless as no oedema was noted, a skin painting was performed during the main study on Day 8, with 0.5 ml of sodium lauryl sulphate at 10 % (W/W) in Codex paraffin to create irritation.
.During the challenge, the topical occlusive application for 24 hours was performed in the treated group and in the control group with the test article in a 1 % (WIW) solution in water for injection and at the dose level of 0.5 ml (Maximum Non-Irritant Concentration : M.N.I.C.).
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Treated group :
-By intradermal route : 3 series of 2 x 0.1 ml injections
*Freund's complete adjuvant at 50 % (V/V) in an isotonic injectable solution
*test article in a 0.1 % (W/W) solution in water for injection ;
*mixture 50/50 (V/V) : test article in a 0.2 % (W/W) solution in water for injection + Freund's complete adjuvant at 50 % (V/V) in an isotonic injectable solution, i.e. a final 0.1 % concentration of the test article.
During the preliminary study, injection of the test article in a 0.1 % solution tinted the skin of the animals thus making observation of erythema impossible. No oedema was noted.
-By topical occlusive route for 48 hours, with 0.5 ml of the test article in a 56 % (W/W) paste in water for injection.
During the preliminary study, the test article tinted the skin of the animals thus making observation of erythema impossible. Nevertheless as no oedema was noted, a skin painting was performed during the main study on Day 8, with 0.5 ml of sodium lauryl sulphate at 10 % (W/W) in Codex paraffin to create irritation.
.During the challenge, the topical occlusive application for 24 hours was performed in the treated group and in the control group with the test article in a 1 % (WIW) solution in water for injection and at the dose level of 0.5 ml (Maximum Non-Irritant Concentration : M.N.I.C.).
- No. of animals per dose:
- 30 animals of both sexes, allocated to one control group of 10 animals (induction: vehicle - challenge : test article) and one treated group of 20 animals (induction and challenge: test article).
- Details on study design:
- .During induction, the applications were performed as follows:
. Treated group:
-By intradermal route: 3 series of 2 x 0.1 ml injections
*Freund's complete adjuvant at 50 % (V/V) in an isotonic injectable solution
*test article in a 0.1 % (W/W) solution in water for injection ;
*mixture 50/50 (V/V): test article in a 0.2 % (W/W) solution in water for injection + Freund's complete adjuvant at 50 % (V/V) in an isotonic injectable solution, i.e. a final 0.1 % concentration of the test article.
During the preliminary study, injection of the test article in a 0.1 % solution tinted the skin of the animals thus making observation of erythema impossible. No oedema was noted.
-By topical occlusive route for 48 hours, with 0.5 ml of the test article in a 56 % (W/W) paste in water for injection.
During the preliminary study, the test article tinted the skin of the animals thus making observation of erythema impossible. Nevertheless as no oedema was noted, a skin painting was performed during the main study on Day 8, with 0.5 ml of sodium lauryl sulphate at 10 % (W/W) in Codex paraffin to create irritation.
Control group:
The intradermal injections and the topical occlusive application for 48 hours were carried out under the same conditions as in the treated group, water for injection replacing the test article.
The rest period was 11 days without treatment.
During the challenge, the topical occlusive application for 24 hours was performed in the treated group and in the control group with the test article in a 1 % (WIW) solution in water for injection and at the dose level of 0.5 ml (Maximum Non-Irritant Concentration: M.N.I.C.).
The cutaneous macroscopic examinations were performed 24 and 48 hours after removal of the patches to the challenge application site, according to the Magnusson & Kligman scale. As the test article tinted the skin of the animals, thus making observation of erythema impossible, histopathological examinations of the skin were performed for all the animals of the treated and control groups (in half of them at 24 hours and in the other half at 48 hours). - Challenge controls:
- one control group of 10 animals (induction : vehicle - challenge : test article)
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- None
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0.
Any other information on results incl. tables
Determination of a weak to moderate irritant concentration by intradermal injection
Evaluation of the reactions at different observation times | |||||||
24 hours | 48 hours | ||||||
After the intradermal injections | |||||||
Sex/Guinea pig No | Concentrations | 1% | 0.10% | 0.05% | 1% | 0.10% | 0.05% |
M/61675 | Erthema (+Oedema) | 3 | ? | ? | ? | ? | ? |
Other anomaly | Y | U | U | U | U | U | |
M/61676 | Erthema (+Oedema) | ? | ? | ? | ? | ? | ? |
Other anomaly | U | U | U | U | U | U | |
F/61677 | Erthema (+Oedema) | 3 | ? | ? | ? | ? | ? |
Other anomaly | Y | U | U | U | U | U | |
F/61678 | Erthema (+Oedema) | ? | ? | ? | ? | ? | ? |
Other anomaly | U | U | U | U | U | U |
? - Reading impossible
U - The test article tinted the skin of the animals thus making erythema observation impossible. No oedema was noted.
Y - The test article tinted the skin making erythema observation impossible. The maximum score (score = 3) was attributed because of the presence of oedema.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- From the results obtained under the experimental conditions employed, the test article did not provoke any reaction of cutaneous sensitization in the animals examined.
- Executive summary:
A GLP compliant OECD guideline 406 test was performed in the albino Hartley guinea-pig (supplier Charles River France), to evaluation of the delayed cutaneous hypersensitivity of the test article according to a maximized protocol using 30 animals of both sexes, allocated to one control group of 10 animals (induction : vehicle - challenge : test article) and one treated group of 20 animals (induction and challenge : test article).
Animals were exposed to test article by 3 series of 2 X 0.1 ml injections. Test solution was made as 0.1% (W/W) solution in water for injection.
During the preliminary study, the test article tinted the skin of the animals thus making observations of erythema impossible. Nevertheless as no oedema was noted, a skin painting was performed during the main study on Day 8, with 0.5 ml of sodium lauryl sulphate at 10% (W/W) in Codex paraffin to create irritation.
After a rest period of 11 days, challenge study was performed with the topical occlusive application for 24 h in treated and control group with the test article in a 1% (W/W) solution in water for injection and at the dose level of 0.5 ml (Maximum Non-irritant concentration)
The cutaneous macroscopic examination were performed 24 and 48 h after removal f the patches to the challenge application site, according to the Magnusson & Kligman scale. As the test article tinted the skin of the animals, thus making observations of erythema impossible, histopathological examination of the skin were performed for all the animals of the treated and control groups.
Signs of irritation were noted during induction after application of sodium lauryl sulphate in both groups. After challenge, the macroscopic and histopathological examinations did not reveal any lesion of delayed hypersensitivity in the 20 treated animals. No noticeable cutaneous abnormality was noted in the 10 guinea-pigs examined in the control group.
From the results obtained under the experimental conditions employed, the test article did not provoke any reaction of cutaneous sensitization in the animals examined. Hence, the test substance is regarded as non-sensitizer.
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