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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 266-577-8 | CAS number: 67109-27-7
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium bis[2-chloro-4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-hydroxybenzenesulphonamidato(2-)]chromate(1-)
- EC Number:
- 266-577-8
- EC Name:
- Sodium bis[2-chloro-4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-hydroxybenzenesulphonamidato(2-)]chromate(1-)
- Cas Number:
- 67109-27-7
- Molecular formula:
- C32H24Cl2CrN10O8S2.Na
- IUPAC Name:
- sodium bis[2-chloro-4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-hydroxybenzenesulphonamidato(2-)]chromate(1-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Inhouse
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: Male 2.93 kg and Female 2.78 kg
- Housing: caged singly
- Diet: A commercial irradiated diet (Styles-Oxoid) was fed ad lib ad libitum
- Water: Sterile filtered water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 10 h light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- FAT 20028/A was applied to each side in quantities of 0.5 g.
- Duration of treatment / exposure:
- The gauze patches were removed 24 h after the application.
- Observation period:
- 24 -72 h
- Number of animals:
- 6 rabbits (3 males and 3 females)
- Details on study design:
- Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10 % of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact. 10g of the test compound mixed with 10 mls of water to make a solution of 15 ml 0.75 ml of which was applied to each test site on a 2.5cm square gauze pad. These were covered with aluminium foil secured with "Sleek"* adhesive tape. The test sites were then covered by a 6" wide "Coban" self adhesive bandage in order to retain the test substance in close contact with the skin. After 24 h the dressing was removed and' the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 h and for any further period considered necessary up to 14 days.
SCORING SYSTEM:
Evaluation of Skin Reactions
Erythema and Eschar Formation
-No erythema: 0
-Slight erythema (barely perceptible): 1
-Well defined erythema: 2
-Moderate to severe erythema: 3
-Severe erythema (beet red) to slight eschar formation: 4
Edema Formation
-No oedema: 0
-Very slight oedema (barely perceptible): 1
-Slight oedema (edges of area well defined, by definite raising): 2
-Moderate oedema (raised approximately 1 mm.): 3
-Severe-oedema (raised more than 1 mm. and extending beyond the area of exposure): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 males and 3 females
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 males and 3 females
- Time point:
- 24 h
- Score:
- 1.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- intact skin and abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 males and 3 females
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin and abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 males and 3 females
- Time point:
- 24 h
- Score:
- 2.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 males and 3 females
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 males and 3 females
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 males and 3 females
- Time point:
- 72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 rabbit
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- intact skin and abraded skin
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- 3 males and 3 females
- Time point:
- 24/48/72 h
- Score:
- 1.63
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 1.6.
Any other information on results incl. tables
Erythema Score
Animal Number |
Intact skin |
Abraded skin |
||
|
24 h |
72 h |
24 h |
72 h |
11 |
1 |
0 |
1 |
0 |
13 |
1 |
0 |
1 |
0 |
15 |
1 |
0 |
1 |
0 |
12 |
1 |
0 |
1 |
0 |
14 |
1 |
0 |
2 |
0 |
16 |
1 |
0 |
1 |
0 |
Mean |
1 |
0 |
1.17 |
0 |
Edema Score
Animal Number |
Intact skin |
Abraded skin |
||
|
24 h |
72 h |
24 h |
72 h |
11 |
2 |
0 |
1 |
0 |
13 |
3 |
0 |
3 |
1 |
15 |
2 |
0 |
2 |
0 |
12 |
2 |
0 |
2 |
0 |
14 |
2 |
0 |
2 |
0 |
16 |
2 |
0 |
2 |
0 |
Mean |
2.17 |
0 |
2 |
0.17 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20028/B cosidered as to be non-irritating to rabbit skin.
- Executive summary:
The purpose of this test was to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound on the skin of the rabbits. The procedure adopted was the patch-test technique described in the " "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1955). Six rabbits (3 males/3 females), New Zealand White (Porton strain), weighing 2.78 to 2.93 kg and aged 12 -16 weeks. Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10 % of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact. 10 g of the test compound mixed with 10mls of water to make a solution of 15 ml 0.75 ml of which was applied to each test site on a 2.5 cm square gauze pad. These were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then covered by a 6" wide "Coban" self-adhesive bandage in order to retain the test substance in close contact with the skin. After 24 h the dressing was removed and' the intact and abraded application sites were assessed for oedema and erythema. Slight to well defined erythema and very slight to moderate oedema were seen on all sites after 24 h while very slight oedema was seen on 1/6 abraded sites after 72 h. All other sites were normal. The remaining site was become normal 6 days. In conclusion, the primary irritation to the skin of rabbits was found to be 1.6 and FAT 20028/B cosidered as to be non-irritating to rabbit skin.
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.