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Reaction mass of lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate and lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-{[4-(vinylsulfonyl)phenyl]diazenyl}naphthalene-2,7-disulfonate
EC number: 941-533-7 | CAS number: -
- 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
Endpoint summary
Administrative data
Description of key information
The test substance might have sensitizing properties based on skin fold thickness measurements.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- additional measurement of skin thickness with cutimeter
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study has been conducted when the LLNA was not yet the standard method.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstr. 27, 0-33178 Borchen, SPF breeding colony.
- Body weight at start of study: 291-405 g
- Age at start of study: 5-8 wk
- Housing: in macrolon cages (type 4) on soft wood granulate
- Diet: Altromin 3022 for guinea pigs, ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: at least 8 d
- Animal identification: fur marking and cage numbering
ENVIRONMENTAL CONDITIONS
- Temperature: 21-23°C
- Humidity: 35-60%
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From: August 24, 1999 To: September 24, 1999 - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.5% / 0.1 mL
- Day(s)/duration:
- Day 1 - one injection in water and one injection in water and Freund's Adjuvant
- Adequacy of induction:
- other: highest possible concentration not leading to complete discolouration of animal
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 10% / 0.5 mL
- Day(s)/duration:
- Day 8 - for 48 hours
- Adequacy of induction:
- highest technically applicable concentration used
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 10% / 0.5 mL
- Day(s)/duration:
- Day 22 - for 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 10% / 0.5 mL
- Day(s)/duration:
- Day 36 - for 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 2 x 10 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal + 1 epicutaneous
- Exposure period: intradermal: 24 hours; epicutaneous: 48 hours
- Test groups: 1
- Control group: 2
- Site: shoulder
- Frequency of applications: Day 1; Day 8
- Duration: 24 and 48 hours
- Concentrations: 0.5 and 10%
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: Day 22 and Day 36
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1 + 1
- Site: flank
- Concentrations: 10%
- Evaluation (hr after challenge): 24 and 48 hours after removal of patches
as the blue discolouration of the skin did not allow the evaluation of skin reddening, the thicknes of skin folds was measured with a cutimeter before and after challenge treatment to assess for sensitising properties - Positive control substance(s):
- yes
- Remarks:
- formaldehyde
- Positive control results:
- 1. Challenge: 2% formaldehyde - positive effects in the treatment group and to a lesser effect in the control group
2. Challenge: 0.5% formaldehyde - positive effects in the treatment group and to a lesser effect in the control group - Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% test substance
- Total no. in group:
- 10
- Clinical observations:
- skin fold thickness: pre-treatment: 1.52 after challenge: 1.66 (test substance flank) = 0.14
- Remarks on result:
- other: skin fold thickness
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 10% test substance
- Total no. in group:
- 10
- Clinical observations:
- skin fold thickness: pre-treatment: 1.52 after challenge: 1.66 (test substance flank) = 0.14
- Remarks on result:
- other: skin fold thickness
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- Total no. in group:
- 10
- Clinical observations:
- skin fold thickness: pre-treatment: 1.48 - after challenge: 1.59 (control flank) = 0.11
- Remarks on result:
- other: skin fold thickness
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0
- Total no. in group:
- 10
- Clinical observations:
- skin fold thickness: pre-treatment: 1.48 - after challenge: 1.59 (control flank) = 0.11
- Remarks on result:
- other: skin fold thickness
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% test substance
- Total no. in group:
- 20
- Clinical observations:
- skin fold thickness: pre-treatment: 1.57 - after challenge: 1.84 (test substance flank) = 0.27
- Remarks on result:
- other: skin fold thickness
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10% test substance
- Total no. in group:
- 20
- Clinical observations:
- skin fold thickness: pre-treatment: 1.57 - after challenge: 1.78 (test substance flank) = 0.21
- Remarks on result:
- other: skin fold thickness
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0
- Total no. in group:
- 20
- Clinical observations:
- skin fold thickness: pre-treatment: 1.53 - after challenge: 1.65 (control flank) = 0.12
- Remarks on result:
- other: skin fold thickness
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0
- Total no. in group:
- 20
- Clinical observations:
- skin fold thickness: pre-treatment: 1.53 - after challenge: 1.63 (control flank) = 0.10
- Remarks on result:
- other: skin fold thickness
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% test substance
- Total no. in group:
- 10
- Clinical observations:
- skin fold thickness: pre-treatment: 1.46 - after challenge: 1.59 (test substance flank) = 0.13
- Remarks on result:
- other: skin fold thickness
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 10% test substance
- Total no. in group:
- 10
- Clinical observations:
- skin fold thickness: pre-treatment: 1.46 - after challenge: 1.62 (test substance flank) = 0.16
- Remarks on result:
- other: skin fold thickness
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- Total no. in group:
- 10
- Clinical observations:
- skin fold thickness: pre-treatment: 1.45 - after challenge: 1.54 (control flank) = 0.09
- Remarks on result:
- other: skin fold thickness
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0
- Total no. in group:
- 10
- Clinical observations:
- skin fold thickness: pre-treatment: 1.45 - after challenge: 1.51 (control flank) = 0.06
- Remarks on result:
- other: skin fold thickness
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% test substance
- Total no. in group:
- 20
- Clinical observations:
- skin fold thickness: pre-treatment: 1.73 - after challenge: 1.84 (test substance flank) = 0.11
- Remarks on result:
- other: skin fold thickness
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10% test substance
- Total no. in group:
- 20
- Clinical observations:
- skin fold thickness: pre-treatment: 1.73 - after challenge: 1.97 (test substance flank) = 0.24
- Remarks on result:
- other: skin fold thickness
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0
- Total no. in group:
- 20
- Clinical observations:
- skin fold thickness: pre-treatment: 1.67 - after challenge: 1.69 (control flank) = 0.02
- Remarks on result:
- other: skin fold thickness
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0
- Total no. in group:
- 20
- Clinical observations:
- skin fold thickness: pre-treatment: 1.67 - after challenge: 1.74 (control flank) = 0.07
- Remarks on result:
- other: skin fold thickness
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.5%
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 0.5%
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Remarks:
- there might be skin sensitising properties based on skin fold thickness measurements
- Conclusions:
- The test substance might have sensitizing properties based on skin fold thickness measurements.
- Executive summary:
A guinea pig maximization test was conducted to evaluate the skin sensitization potential of the test substance according to OECD Guideline 406, in compliance with GLP. Concentrations of the test substance at 5 and 25% in deionized water were selected for the intradermal and dermal inductions. The test substance is a blue dye that strongly colours the skin, making it impossible to evaluate skin irritation reactions such as reddening. Therefore, effects were measured as thickness of a skin fold using a cutimeter. At the first reading (concentration: 10%), differences in skin fold thickness were seen in the treated groups between the treated and control flanks. The difference was notable at 48 h and slightly attenuated at 72 h. These effects between substance and sham-treated sides were less pronounced in the control animals. The second reading (concentration: 10%) yielded similar results. However, the increases in skin fold thickness was less distinctive after 48 h, but was more pronounced at 72 h in the treated group. Under the study conditions, the test substance might have sensitizing properties (Heiman, 1986).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A guinea pig maximization test was conducted to evaluate the skin sensitization potential of the test substance according to OECD Guideline 406, in compliance with GLP. Concentrations of the test substance at 5 and 25% in deionized waterwere selected for the intradermal and dermal inductions. The test substance is a blue dye that strongly colours the skin, making it impossible to evaluate skin irritation reactions such as reddening. Therefore, effects were measured as thickness of a skin fold using a cutimeter.
Skin thickness after 1stChallenge
Group
Dose level [%]
Skin-fold thickness [mm]
Difference to pre-treatment [mm]
pre-treatment
48 h reading
72 h reading
48 h
72 h
Negative control
0
1.48
1.59
1.59
0.11
0.11
10
1.52
1.66
1.66
0.14
0.14
Test group
0
1.53
1.65
1.63
0.12
0.10
10
1.57
1.84
1.78
0.27
0.21
Skin thickness after 2ndChallenge
Group
Dose level [%]
Skin-fold thickness [mm]
Difference to pre-treatment [mm]
pre-treatment
48 h reading
72 h reading
48 h
72 h
Negative control
0
1.45
1.54
1.51
0.09
0.06
10
1.46
1.59
1.62
0.13
0.16
Test group
0
1.67
1.69
1.74
0.02
0.07
10
1.73
1.84
1.97
0.11
0.24
At the first reading (concentration: 10%), differences in skin fold thickness were seen in the treated groups between the treated and control flanks. The difference was notable at 48 h and slightly attenuated at 72 h. These effects between substance and shame treated sides were less pronounced in the control animals. The second reading (concentration: 10%) yielded similar results. However, the increases in skin fold thickness was less distinctive after 48 h, but was more pronounced at 72 h in the treated group.Under the study conditions, the test substance might have sensitizing properties (Heiman, 1986).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of an in vivo guinea pig maximisation test, a classification of Category 1B for skin sensitization is required for the test substance according to CLP (EC 1272/2008) criteria.
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.
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