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EC number: 275-959-3 | CAS number: 71735-61-0
- 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:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Savinyl Red 3BLS
- IUPAC Name:
- Savinyl Red 3BLS
- Reference substance name:
- Sodium bis[4-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-N-(3-me¬thoxypropyl)benzenesulphonamidato(2 )]cobaltate (1-)
- IUPAC Name:
- Sodium bis[4-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-N-(3-me¬thoxypropyl)benzenesulphonamidato(2 )]cobaltate (1-)
- Reference substance name:
- Sodium bis[4-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-N-(3-methoxypropyl)benzenesulphonamidato(2-)]cobaltate(1-)
- EC Number:
- 275-959-3
- EC Name:
- Sodium bis[4-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-N-(3-methoxypropyl)benzenesulphonamidato(2-)]cobaltate(1-)
- Cas Number:
- 71735-61-0
- Molecular formula:
- C40H38CoN6O10S2.Na
- IUPAC Name:
- Cobaltate(1-), bis[4-(hydroxy-kO)-3-[2-[2-(hydroxy-kO)-1-naphthalenyl]diazenyl-kN1]-N-(3-methoxypropyl)benzenesulfonamidato(2-)]-, sodium (1:1)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Information as provided by the Sponsor. A Certificate of Analysis supplied by the Sponsor is given in Annex 1 (see attachment 1)
Identification: Savinyl Red 3BLS
Other name: Sodium bis[4-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-N-(3-me¬thoxypropyl)benzenesulphonamidato(2 )]cobaltate (1-)
C.I. Index: Solvent Red 91 (S. R. 91)
CAS number: 71735-61-0
Batch: AAM0021341
Physical state/Appearance: very dark red powder
Purity: 93.2% (w/w)
Expiry Date: 13 October 2021
Storage Conditions: room temperature in the dark
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animal Information
Two New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Envigo RMS (UK) Limited, Leicestershire, UK. At the start of the study the animals weighed 2.65 or 3.13 kg and were 12 to 52 weeks old. After an acclimatization period of at least 5 days each animal was given a number unique within the study which was written with a black indelible marker pen on the inner surface of the ear and on the cage label.
Animal Care and Husbandry
The animals were individually housed in suspended cages. Free access to mains drinking water and food (2930C Teklad Global Rabbit diet supplied by Envigo RMS (UK) Limited, Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: test material was moistened with 0.5 ml of distilled water.
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of the test item, moistened sufficiently with 0.5 mL of distilled water, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 2
- Details on study design:
- On the day before the test each of a group of two rabbits was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. At each test site a quantity of 0.5 g of the test item, moistened sufficiently with 0.5 mL of distilled water, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.
Four hours after application the corset and patches were removed from each animal and any residual test item removed by gentle swabbing with cotton wool soaked in 74% industrial methylated spirits.
Immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale:
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Erythema/Eschar Formation
- Basis:
- animal: 75365 Male
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: Erythema/Eschar Formation
- Basis:
- animal: 75371 male
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: Oedema Formation
- Basis:
- animal: 75365 male
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: Oedema Formation
- Basis:
- animal: 75371 male
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- The individual scores for erythema/eschar and edema are given in Appendix 1.
Very slight erythema and very slight edema were noted at both treated skin sites immediately after patch removal. Well defined erythema and very slight or slight edema were noted at both treated skin sites 1 hour after patch removal and at the 24 Hour observation. Well defined erythema and very slight edema were noted at one treated skin site and very slight erythema and very slight edema were noted at the other treated skin site at the 48 Hour observation. Very slight erythema, with or without very slight edema, were noted at both treated skin sites at the 72 Hour observation.
Light brown discoloration of the epidermis was noted at both treated skin sites 1 and 24 hours after patch removal.
Both treated skin sites appeared normal at the 7 Day observation. - Other effects:
- Body Weight
Individual body weights and body weight change are given in Appendix 2.
Both animals showed expected gain in body weight during the study
Any other information on results incl. tables
Appendix1 Skin Irritation Scores
Individual Scores for Skin Irritation
Rabbit Number and Sex |
Observation Time |
Erythema/Eschar Formation |
Edema Formation |
75365Male |
Immediate |
1 |
1 |
75371Male |
1 |
1 |
|
75365Male |
1 Hour |
2Br |
2 |
75371Male |
2Br |
1 |
|
75365Male |
24 Hour |
2Br |
2 |
75371Male |
2Br |
1 |
|
75365Male |
48 Hour |
2 |
1 |
75371Male |
1 |
1 |
|
75365Male |
72 Hour |
1 |
1 |
75371Male |
1 |
0 |
|
75365Male |
7 Days |
0 |
0 |
75371Male |
0 |
0 |
Br= Light brown discoloration of the epidermis
Appendix 1 (continued) Skin Irritation Scores
Mean Values after 24, 48 and 72 Hours
Rabbit Number |
Number of available data points |
Erythema/Eschar Formation |
Edema Formation |
75365Male |
3 |
1.7 |
1.3 |
75371Male |
3 |
1.3 |
0.7 |
Assessment According to Regulation (EC) No. 1272/2008
Evaluated Intervals |
Erythema/Eschar Formation |
Edema Formation |
24 Hours |
Not classified |
Not classified |
48 Hours |
||
72 Hours |
Appendix 2 Individual Body Weights and Body Weight Change
Rabbit Number |
Individual Body Weight (kg) |
Body Weight Change (kg) |
|
Day 0 |
Day 7 |
||
75365Male |
3.13 |
3.33 |
0.20 |
75371Male |
2.65 |
2.87 |
0.22 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the findings in this study, the test item does not meet the criteria for classification according to Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of 16 December 2008.
- Executive summary:
The skin irritation potential of the test item was investigated according to a method compatible with OECD test guideline No. 404 and Method B4. 0.5 g of the test item was applied to the intact skin of two young adult New Zealand White rabbits. Scoring of skin irritation effects was performed approximately 1, 24, 48 and 72 hours and 7 days after test item application.
The mean score was calculated separately for each animal across three scoring times (24, 48 and 72 hours after application) for erythema and edema. The individual mean scores for erythema were 1.3 or 1.7 and 0.7 or 1.3 for edema.
The application of the test item onto
the skin resulted in well-defined erythema, very slight or slight edema and light brown discoloration of the epidermis. These effects were reversible and were no longer evident 7 days after treatment in both animals (end of the observation period). No corrosion was observed at any of the measuring intervals. No clinical signs of toxicity were observed.Thus, the test item did not induce significant or irreversible damage to the rabbit skin.
According to the findings in this study, the test item
does not meet the criteria for classification according to Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of 16 December 2008.
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