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EC number: 287-791-8 | CAS number: 85585-89-3
- 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:
- September 14th, 1992 to October 16th, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- EG-Guideline B.6. Acute Toxicity Sensitization of the Skin of the Directive 84/449/EWG: Commission Directive of 25 April 1984 adapting to technical progress for the sixth time Council Directive 67/548/EWG on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- OECD-Guideline for testing of chemicals, 406 "Skin Sensitization", Adopted 12 May 1981
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Available study data is over 12 years old.
Test material
- Reference substance name:
- Trisodium [5-acetamido-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonato(5-)]cuprate(3-)
- EC Number:
- 263-856-6
- EC Name:
- Trisodium [5-acetamido-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonato(5-)]cuprate(3-)
- Cas Number:
- 63105-49-7
- Molecular formula:
- C20H14CuN3O15S4.3Na C20H14CuN3Na3O15S4
- IUPAC Name:
- trisodium 15-acetamido-7-[2-(sulfonatooxy)ethanesulfonyl]-10λ³,12λ³-dioxa-2λ⁴,3-diaza-11-cuprapentacyclo[11.8.0.0²,¹¹.0⁴,⁹.0¹⁴,¹⁹]henicosa-1(21),2,4,6,8,13,15,17,19-nonaene-11,11-bis(ylium)-10,12-diide-17,21-disulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Test species: Pirbright-White guinea pig
Sex: female
Strain: Hoe: DHPK (SPFLac)
Origin: HOECHST AG, Kastengrund, SPF breeding colony
Body weight at start of study: mean 304 g (= 100.0 %) range 280 g (- 7.8 %) to 329 g (+ 8.2 %)
Numer of animals: 15
Randomisation schemes: 393/92
Animal maintenance: in fully air-conditioned rooms in Makrolon cages (Type 4) on soft wood granulate, in groups of 5 animals
Ambient temperature: 22 ± 3 °C
Rel. atmospheric humidity: 55 ± 20 %
Lighting time: 12 hours daily
Acclimatisation: at least 5 days
Diet: Altromin 3112 for guinea pigs and rabbits, ad libitum
Water: tap water in plastic bottles, ad libitum
Animal identification: fur-marking with KMn04 and cage numbering
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5%
- Day(s)/duration:
- one administration on day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- other: 1:1 preparation of Freund's Complete Adjuvant and physiological saline
- Concentration / amount:
- 5%
- Day(s)/duration:
- one administration on day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 25%
- Day(s)/duration:
- Day 8/ 48 hous
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 25%
- Day(s)/duration:
- Test Day 22/24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 animals in the treatment group and 5 animals in the control group were used.
- Details on study design:
- Preparation of test concentrations
The following vehicles were used:
- Freund's Complete Adjuvant (Behringwerke AG, Marburg)
- isotonic saline (sterile, pyrogen-free; Fresenius AG, Bad Homburg)
Freund's Complete Adjuvant was mixed immediately before use with an equal volume of physiological saline. This 50 % adjuvant solution was administered to the animals by intradermal injection.
For the dermal and intradermal treatments, Remazol-Brilliantviolett 5R neu was applied in isotonic saline [percentages w/v].
For the intradermal injections of the test substance in 50 % Freund's adjuvant, Remazol-Brilliantviolett 5R neu was diluted with isotonic saline and then mixed with an equal volume of Freund's Original Adjuvant [percentages wjv].
The concentrations for the maximisation test cannot be standardised. Suitable concentrations are established in preliminary tests. The selected concentration of the test substance depends on the individual phases of the study.
Determination of the primary non-irritant concentration
In a dermal-occlusive test for primary skin irritation, each of the following test concentrations was applied to the left flank of two guinea pigs:
25% in isotonic saline
5% in isotonic saline
1% in isotonic saline
The hair on the left flank of the animals was removed mechanically. 0.5 ml of the test substance preparation was applied to a 2 x 2 cm cellulose patch, which was then fixed to the left flank and covered occlusively for 24 hours with a bandage and film. 24 hours after removal of the patches, the treated skin areas were examined for erythema and oedema.
Determining of the tolerance of intradermal injections
To determine the tolerance of intradermal injections, each of the following preparations was administered twice by intradermal injection to 3 guinea pigs. The injection sites (sites 1, 2 and 3) were all within a dorsal area measuring 2 x 4 cm in the vicinity of the shoulder.
site appl. vol. in ml conc. in % vehicle
1 2 X 0.1 5.0 isotonic saline
2 2 X 0.1 1.0 isotonic saline
3 2 X 0.1 0.2 isotonic saline
The injection sites (site 1, 2 and 3) were all within a dorsal area measuring 2 x 4 cm in the vicinity of the animals' shoulder.
Main test for sensitisinq properties
Chronological description of the test procedure indicating the day, at which procedure was carried out, on the left margin of the page:
Day 0
The body weights of animals were determined.
The guinea pigs were shaved mechanically over a dorsal area of 4 x 6 cm in the vicinity of the shoulders.
Day 1
Intradermal induction treatment
Two intradermal injections per animal of the following preparations.
The injection sites (site 1, 2 and 3) were all within a dorsal area of 2 x 4 cm. The injection sites were left uncovered.
Treated group:
Site 1: 2 X 0.1 ml 50% Freund's Adjuvant
Site 2: 2 X 0.1 ml 5 % solution of test substance in isotonic saline
Site 3: 2 X 0.1 ml 5 % solution of test substance in 50% Freund's adjuvant
Control and escort groups:
Site 1: 2 x 0.1 ml 50% Freund's Adjuvant
Site 2: 2 x 0.1 ml isotonic saline
Site 3: 2 x 0.1 ml 50% Freund's Adjuvant
Days 1-7
The application area was examined for local tolerance. Any systemic toxic effects were recorded.
Day 8
Dermal induction treatment
0.5 ml of the test substance preparation or the vehicle was applied to a 2 x 4 cm cellulose patch. This patch covered the area where the intradermal injection had been placed. The application area was then kept for 48 hours under an occlusive bandage with an impermeable film and an elastic bandage.
Treated group : 25% test substance in isotonic saline
Control and escort group : isotonic saline
Day 10
Occlusive bandage removed.
Irritant effects recorded.
Days 11-21
No treatment of control or treated group.
Test animals kept under observation.
Days 15-18
Challenge treatment of escort group, carried out in same way as that of control and treated groups (see days 22 - 25).
Day 22
Dermal challenge treatment
One area of approx. 5 x 5 cm on the left flank was shaved mechanically.
0.5 ml of the test substance preparation was applied to a 2 x 2 cm cellulose patch. The application area was then kept for 24 hours under an occlusive bandage with an impermeable film and an elastic bandage.
Treated and control groups (left flank):
25% Remazol-Brilliantviolett 5R neu in isotonic saline
Day 23
Occlusive bandage removed.
Day 24
Skin examined.
Day 25
Skin examined. - Challenge controls:
- yes (escort group)
- Positive control substance(s):
- yes
- Remarks:
- Positive controls were done bi-annually
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- The treated area was discoloured slightly blue.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- The treated area was discoloured slightly blue. One animal was found dead on day 20. A substance related effect was not obvious.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- The treated area was discoloured slightly blue.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- The treated area was discoloured slightly blue. One animal was found dead on day 20. A substance related effect was not obvious.
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Body weight gains
Animal No. |
Body weight at start of study (g) |
Body weight at end of study (g) |
Increase (%) |
Control group: |
|||
1 2 3 4 5 |
317 270 303 306 325 |
342 317 351 325 349 |
+ 8 + 17 + 16 + 6 + 7 |
Treated group: |
|||
6 7 8 9 10 |
280 329 321 310 299 |
303 349 354 344 * |
+ 8 + 6 + 10 + 11 + |
11 12 13 14 15 |
302 307 285 293 312 |
336 338 310 299 353 |
+ 11 + 10 + 9 + 2 + 13 |
*found dead at day 20 of the study.
Scoring of dermal reactions – individual data
Challenge treatment, escort group
Remoazol-Brilliantviolett 5R neu 25% in isotonic saline (day 15)
Treat area: left flank
Scoring of dermal reactions |
||||||
|
Animal No.: |
16 |
17 |
18 |
19 |
20 |
24 hours |
Erythema Oedema Skin surface – slight blue discoloured |
0 0
X |
0 0
X |
0 0
X |
0 0
X |
0 0
X |
|
Animal No.: |
16 |
17 |
18 |
19 |
20 |
48 hours |
Erythema Oedema Skin surface – slight blue discoloured |
0 0
X |
0 0
X |
0 0
X |
0 0
X |
0 0
x |
Challenge treatment: Remazol-Brilliantviolett 5R neu 25% in isotonic saline (day 22)
Treated area: left flank
Time of observation: 24 hours (day 24)
Scoring of dermal reactions |
||||||||||
Control animals |
1 |
2 |
3 |
4 |
5 |
|
|
|
|
|
Erythema Oedema Skin surface – slight blue discoloured |
0 0
X |
0 0
X |
0 0
X |
0 0
X |
0 0
X |
|
|
|
|
|
Treated animals |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
Erythema Oedema Skin surface – slight blue discoloured |
0 0
X |
0 0
X |
0 0
X |
0 0
X |
|
0 0
X |
0 0
X |
0 0
X |
0 0
X |
0 0
X |
Time of observation: 48 hours (day 25)
Scoring of dermal reactions |
||||||||||
Control animals |
1 |
2 |
3 |
4 |
5 |
|
|
|
|
|
Erythema Oedema Skin surface – slight blue discoloured |
0 0
X |
0 0
X |
0 0
X |
0 0
X |
0 0
X |
|
|
|
|
|
Treated animals |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
Erythema Oedema Skin surface – slight blue discoloured |
0 0
X |
0 0
X |
0 0
X |
0 0
X |
|
0 0
X |
0 0
X |
0 0
X |
0 0
X |
0 0
X |
The skin of none treated animals showed a positive reaction during the observation period after the challenge.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, none of the animals of the treatment group showed a positive skin response after the challenge procedure.
Based on the results of this study Remazol-Brilliantviolett 5R neu showed no evidence for sensitizing properties. The test substance is not classifiable according to CLP criteria. - Executive summary:
Testing for sensitizing properties of Remazol-Brilliantviolett 5R neu was performed in female Guinea pigs according to the method of MAGNUSSON & KLIGMAN.
Intradermal induction was performed using 5% Remazol-Brilliantviolett 5R neu in isotonic saline. Dermal induction and challenge treatment were carried out with 25% Remazol-Brilliantviolett 5R neu in isotonic saline.
Based on the results of this study Remazol-Brilliantviolett 5R neu showed no evidence for sensitizing properties.
The test substance is not classified in accordance with CLP criteria.
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