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EC number: 291-103-1 | CAS number: 90341-71-2
- 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:
- since October 12,1992 to November 13,1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliance with international guideline
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)
- Deviations:
- no
- 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:
- Test was not valid at time of test conduct
Test material
- Reference substance name:
- Cuprate(4-), [2-[[[[2-hydroxy-3-sulfo-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]phenylmethyl]azo]-4-sulfobenzoato(6-)]-, sodium
- EC Number:
- 291-103-1
- EC Name:
- Cuprate(4-), [2-[[[[2-hydroxy-3-sulfo-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]phenylmethyl]azo]-4-sulfobenzoato(6-)]-, sodium
- Cas Number:
- 90341-71-2
- Molecular formula:
- C22H14CuN4Na4O15S4
- IUPAC Name:
- Cuprate(4-), [2-[[[[2-hydroxy-3-sulfo-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]phenylmethyl]azo]-4-sulfobenzoato(6-)]-, sodium
- Details on test material:
- - Name of test material:Remazol Brillantblau BB neu
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF breeding colony
- Weight at study initiation: 318 ± 30 g
- Housing: in fully air-conditioned rooms in Makrolon cages (Type 4) on soft wood granulate, in groups of 5 animals
- Diet : Altromin 3112 for guinea pigs and rabbits, ad libitum
- Water : tap water in plastic bottles, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 20 %
- Photoperiod: 12 hours daily
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: isotonic saline solution and Freud's Complete adjuvant
- Concentration / amount:
- 5% of test substance (Intradermal induction treatment)
25% of the test substance (Dermal induction treatment)
25% of the test substance (Dermal challenge treatment)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: isotonic saline solution and Freud's Complete adjuvant
- Concentration / amount:
- 5% of test substance (Intradermal induction treatment)
25% of the test substance (Dermal induction treatment)
25% of the test substance (Dermal challenge treatment)
- No. of animals per dose:
- Determination of primary not irritating concentration: 6
Determination of intradermal tolerability: 3
Sentinel group: 5
Control group: 5
Treatment group: 10 - Details on study design:
- RANGE FINDING TESTS:
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:
25.0 % TS in isotonic saline
5.0 % TS in isotonic saline
1.0 % TS in isotonic saline
The hair on the left flanks 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
Determination of the tolerance of intradermal injections:
To determine the tolerance of intradermal injections, each of the following preparations (5.0%, 1.0%, 0.2% in isotonic saline) 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.
MAIN STUDY
A. INTRADERMAL INDUCTION
- No of Injections: 2 x 3 preparations: 50% FCA, 5% TS in 0.9% NaCl, 5% TS in 50% FCA - treatment group
50% FCA, 0.9% NaCl, 50% FCA - control and attending group
- Exposure period: Injection on Day 1, observation Day 1 to Day 7
- Site: shoulder
B. DERMAL INDUCTION EXPOSURE
- No. of exposures: one
- Exposure period: 48 hours
- Test groups: 25% TS in 0.9% NaCl
- Control group: 0.9% NaCl
- Site: shoulder
- Frequency of applications: single
- Duration: Day 8 to Day 22
- Concentrations: 25%
C. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22 (15 for attending group)
- Exposure period: 24 hours
- Test groups: 25% TS + 0.9% NaCl
- Control group: 25% TS + 0.9% NaCl
- Site: right flank: TS; left flank: 0.9% NaCl
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 hours - Positive control substance(s):
- no
Study design: in vivo (LLNA)
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- dry, rough and encrusted skin
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: dry, rough and encrusted skin.
Any other information on results incl. tables
The substance is considered to be sensitising if 30 % of the animals in the treated group definitely show a positive reaction.
Challenge treatment:
Very slight to moderate erythema and very slight edema as well as dry, rough and encrusted skin were observed in the treatment group 24 and 48 hours after removal of the occlusive bandage. No signs of irritation occurred in the control group. The skin surface of all animals was discolored light blue.
Clinical signs:
The intradermal injections with Freund's Adjuvant caused severe erythema and edema, indurations and encrustations (evaluation of erythema formation was not possible at the sites treated with the test substance due to intensive blue discolourations). The application sites treated with the test substance showed edema, indurations and encrustations. Evaluation of erythema formation was not possible. Injections of the vehicle alone did not cause any sign of irritation. Due to these strong irritation reactions of the skin, 10% sodium dodecylsulfate was not applied at day 7.
After the removal of the patch at day 10, erythema and edema, scabbed and encrusted skin as well as necrosis and open wounds were observed at the application sites. Additionally the application sites of the treatment group were discoloured light blue.
Assessment
Under the conditions of the present study, six of ten animals of the treatment group showed a positive skin response after the challenge procedure.
Based on the results of this study Remazol-Brillantblau BB neu may cause sensitisation by skin contact.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, six of ten animals of the treatment group showed a positive skin response after the challenge procedure.
Based on the results of this study Remazol-Brillantblau BB neu may cause sensitisation by skin contact. - Executive summary:
Testing for sensitising properties of Remazol-Brillantblau BB neu was performed in female Guinea pigs according to the method of MAGNUSSON & KLIGMAN. Intradermal induction was performed using 5 % Remazol-Brillantblau BB neu in isotonic saline. Dermal induction and challenge treatment were carried out with 25 % Remazol-Brillantblau BB neu in isotonic saline.
Very slight to moderate erythema and very slight edema as well as dry, rough and encrusted skin were observed in the treatment group 24 and 48 hours after removal of the occlusive bandage. No signs of irritation occurred in the control group. The skin surface of all animals was discolored light blue.
Under the conditions of the present study, six of ten animals of the treatment group showed a positive skin response after the challenge procedure.
Based on the results of this study Remazol-Brillantblau BB neu may cause sensitisation by skin contact.
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