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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 404-600-7 | CAS number: 129009-88-7 EVERZOL ORANGE GR; ORANGE HF-SNK; REAKTIV ORANGE FD 19969 FW
- 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:
- From Sep. 30, 1997 to Dec. 09, 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
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:
- Study was already available
Test material
- Reference substance name:
- Disodium 6-(4,6-dichloro-1,3,5-triazin-2-ylamino)-1-hydroxy-2-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-3-sulfonate
- EC Number:
- 404-600-7
- EC Name:
- Disodium 6-(4,6-dichloro-1,3,5-triazin-2-ylamino)-1-hydroxy-2-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-3-sulfonate
- Cas Number:
- 129009-88-7
- Molecular formula:
- Hill formula: C21H14Cl2N6Na2O10S3 CAS formula: C21H16Cl2N6O10S3.2Na
- IUPAC Name:
- disodium 7-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Reaktiv-Orange FD 19969 FW
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: HARLAN WINKELMANN Gartenstr. 27, D-33178 Borchen, SPF breeding colony
- Weight at study initiation: 369 g
- Housing: Macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet: ssniff Ms-H (V2233), ad libitum
- Water: Tap water in plastic bottles, ad libitum
- Acclimation period: At least 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light
IN-LIFE DATES: From: Sep. 30, 1997 To: Oct. 31, 1997
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5% / 0.1 mL per injection
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25 % / 0.5 mL
- Day(s)/duration:
- Day 8 / 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25 % / 0.5 mL
- Day(s)/duration:
- Day 22 / 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- - Determination of the primary non-irritant concentration: 3
- Determination of the tolerance of the intradermal injections: 2
- Control group: 5
- Treatment group: 10 - Details on study design:
- RANGE FINDING TESTS:
Determination of the primary non-irritant concentration:
The following test concentrations were administered to the flanks of two guinea pigs:
25.0 % in deionised water
5.0 % in deionised water
1.0 % in deionised water
0.5 mL of the test substance preparation was administered to a 2 x 2 cm cellulose patch, which was fixed to the flank and covered occlusively for 24 h with a bandage and film. 24 h after removal of the patches, the treated skin areas were examined for erythema and edema.
Determination of the tolerance of the intradermal injections:
The following preparations were administered twice by intradermal injection to 2 guinea pigs:
Site 1. 2X0.1 mL 5.0 % in deionised water
Site 2. 2X0.1 mL 1.0 % in deionised water
Site 3. 2X0.1 mL 0.2 % in deionised water
24, 48, 72 and 96 h after administration the injection sites were examined for local tolerance.
MAIN STUDY
A. INDUCTION EXPOSURE (Intradermal)
- No. of exposures: 2
- Exposure period: 1-7 d
- Test groups: Yes
- Control group: Yes, (50 % Freund's Adjuvant)
- Site: Dorsal area
- Frequency of applications: Single on Day 1 (2 intradermal injections/animal)
- Duration: 7 d
- Concentrations: 5.0 % test substance in deionised water
INDUCTION EXPOSURE (Dermal)
- No. of exposures: 0.5 mL of the test substance preparation as cellulose patch
- Test groups: Yes, 25.0 % test substance in deionised water
- Control group: Yes, deionised water
- Site: Dorsal area
- Frequency of applications: Single on Day 8
- Exposure period: 48 h under an occlusive bandage covered with an impermeable film and an elastic bandage.
- Concentrations: 25.0 % test substance in deionised water
B. CHALLENGE EXPOSURE (Dermal)
- No. of exposures: One
- Day(s) of challenge: Day 22
- Exposure period: 24 h under an occlusive bandage covered with an impermeable film and an elastic bandage.
- Test groups: 25.0 % test substance in deionised water
- Control group: 25.0 % test substance in deionised water
- Site: Left flank
- Concentrations: 25 % test substance in deionised water
- Evaluation (hr after challenge): 24 and 48 h after removal of the patches
OTHER:
The substance is considered to be sensitizing if 30 % or more of the animals in the treatment group definitely showed a positive skin reaction and at the same time no irritant effects have - Positive control substance(s):
- yes
- Remarks:
- The validity of the test system Is confirmed by the periodically conducted positive control test using benzocain for the maximization test (Hoechst Marion Roussel, Preclinical Development Germany, Drug Safely) DyStar, TO-ECO, Germany, Report number 97.032
Results and discussion
- Positive control results:
- The validity of the test system Is confirmed by the periodically conducted positive control test using benzocain for the maximization test (Hoechst Marion Roussel, Preclinical Development Germany, Drug Safely) DyStar, TO-ECO, Germany, Report number 97.0326, 1997-06-02
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Determination of the primary non-irritant concentration
No signs of irritation occurred after administration of the different test concentrations.
Based on these results, a concentration of 25.0 % test substance in deionised water was chosen for the challenge at Day 22.
Determination of the tolerance of the intradermal injections
The intradermal injections with the 5.0 % preparation caused severe erythema and oedema as well as indurations and encrustations.
Based on this preliminary test, a 5.0 % preparation was selected for the intradermal injections in the main test.
Main test for the sensitizing properties
Body weight gains and clinical signs:
The body weight gains of the animals were not impaired.
The treated animals showed no clinical signs of intoxication throughout the study
Intradermal induction treatment
The intradermal injections with Freund's Adjuvant (with and without test substance) caused severe erythema and edema as well as indurations and encrustations. The administration sites treated with the test substance in deionized water showed well defined erythema and edema. Intradermal injections of the vehicle alone exhibited no signs of irritation.
Due to these strong irritation reactions of the skin, 10% sodium dodecylsulfate was not administered at Day 7.
Dermal induction treatment
After the removal of the patches at Day 10, severe erythema and edema, indurated, scabbed and encrusted skin as well as necrosis were observed at the sites previously treated with Freund's Adjuvant. The administration sites treated with the test substance or vehicle alone exhibited no signs of irritation.
Dermal challenge treatment
No skin reactions were observed in the control and the treatment group 24 and 48 h after removal of the occlusive bandage.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance showed no evidence for sensitizing properties in guinea pigs.
- Executive summary:
A study was conducted to assess the sensitizing potential of the test substance in female Pirbright-White guinea pigs (Magnusson & Kligman method) according EU Method B.6. and OECD guideline 406 in compliance with GLP.
Intradermal induction was performed using 5 % test substance in deionised water. Dermal induction and challenge treatment were carried out with 25 % test substance in deionised water.
None of ten animals of the treatment group showed a positive skin response after the challenge exposure.
The validity of the test system Is confirmed by the periodically conducted positive control test using benzocain for the maximization test.
Under the test conditions, the test substance showed no evidence for sensitizing properties in guinea pigs.
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.