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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 941-481-5 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- performed on analogue substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA method was not available at the time of testing
Test material
- Reference substance name:
- A 2:1:1 mixture of: trisodium N(1')-N(2):N(1''')-N(2'')-η-6-[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]-6''-(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'-azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate
- EC Number:
- 402-850-1
- EC Name:
- A 2:1:1 mixture of: trisodium N(1')-N(2):N(1''')-N(2'')-η-6-[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]-6''-(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'-azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate
- Molecular formula:
- not applicable being an UVCB
- IUPAC Name:
- reaction mass of: trisodium N(1')-N(2):N(1''')-N(2'')-η-6-[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]-6''-(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'-azobenzene-1,2'-diolato-O(1),O(2'))-chromate;trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate;trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate (2:1:1)
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- EST ANIMALS
- Source: Kleintierfarm Madörin, 4414 Füllinsdorf, CH
- Females nulliparous and non-pregnant: yes
- Microbiological status of animals: not specified
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: males: 383 to 447 g; females: 425 to 486 g
- Housing: individually in Makrolon type-3 cages with standard softwood bedding ("Lignocell", Schill AG, 4132 Muttenz, CH)
- Diet: ad libitum; Pelleted standard Kliba 342, batch 38/87 guinea pig breeding/maintenance diet ("Kliba", Klingentalmühle AG, 4303 Kaiseraugst, CH); subjected to analysis for contaminants (results included in report)
- Water: ad libitum; community tap water from Itingen, subjected to analyses for contaminants (results included in report)
- Acclimation period: one week under test conditions after veterinary health examination
- Indication of any skin lesions: not specified
- Identification: by unique cage number and corresponding ear tags
- Randomisation: randomly selected at time of delivery
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 40 to 70 %
- Air changes: 10 to 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: 50:50 Freunds' complete adjuvant and physiological saline
- Concentration / amount:
- 0%
- Day(s)/duration:
- single injection
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 1%
- Day(s)/duration:
- single injection
- Route:
- intradermal
- Vehicle:
- other: 50:50 Freunds' complete adjuvant and physiological saline
- Concentration / amount:
- 1%
- Day(s)/duration:
- single injection
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 25%
- Day(s)/duration:
- 48 hours
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- left flank: 25%
Right flank: 0% - Day(s)/duration:
- 24 hours
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Left flank: 0%
Right flank: 25% - Day(s)/duration:
- 24h
- No. of animals per dose:
- Preliminary study: 6 animals (intradermal testing: 1 male and 1 female; epidermal testing: 2 males and 2 females)
Control: 10 animals (5 males, 5 females)
Test: 20 animals (10 males, 10 females)
Total: 36 animals (18 males, 18 females) - Details on study design:
- RANGE FINDING TESTS: PRELIMINARY STUDY
- The objective of this investigation was to identify irritant test item concentrations for the induction phase of the main study. In addition, a suitable non-irritant concentration of test item, by topical administration, was identified for the challenge application.
- INTRADERMAL INJECTIONS: 0.1 ml was administrated into the clipped flank of two guinea pigs (1 male and 1 female) at concentrations of 0.1, 0.3, 0.5, 1.0, 3.0 and 5.0 % test item in physiological saline and assessed for dermal reactions (erythema, oedema and diameter in mm) after 24 hours.
- EPIDERMAL APPLICATIONS: 2 x 2 cm patches of filter paper were saturated with concentrations of 3, 5, 10 and 25 % test item in physiological saline and applied to the clipped, shaved flanks of four guinea pigs. The patches were covered by a strip of aluminium foil and firmly secured by elastic plaster wrapped around the trunk and covered with impervious adhesive tape. The dressings were removed after 24 hours and the reaction sites were assessed for erythema and oedema. Further examinations of the sites were performed 24 and 48 hours after the removal of the dressing.
- RESULTS AND CONCLUSIONS: following intradermal injections, no erythema was recorded at any concentration at either 0 or 24 hours, and oedema was observed in 1 animal at 1.0 % test item, and both animals at concentrations of 3.0 and 5.0 % 24 hours after injections. 1.0 % was the lowest concentration to produce positive reaction. Following epidermal applications, no erythema and no oedema was observed among any animals or any test item concentrations 24 hours after application of the test item. 25 % was the highest concentration of test item tested, and it produced no positive reactions.
MAIN STUDY
A. INDUCTION EXPOSURE
I) INTRADERMAL INJECTIONS: 6 x 8 cm area was clipped free of hair and administered 3 pairs of 0.1 ml intradermal injections per site at the border of a 4 x 4 cm area within the clipped area.
- No. of exposures: 3 pairs of injections
- Test groups: 10 males and 10 females
- Control group: 5 males and 5 females
- Site: clipped dorsal skin from the scapular region
- Frequency of injections: once
- Concentrations: 1st pair: Freunds' complete adjunct 50:50 with physiological saline; 2nd pair: 1 % test item in physiological saline; 3rd pair: 1 % test item in Freunds' complete adjunct 50:50 with physiological saline (control group: 0 % test item in 2nd and 3rd pair of injections).
- Duration: day 1
II) EPIDERMAL APPLICATIONS: one week after the intradermal injections, the same region was re-clipped and a a patch of 4 x 4 cm filter paper was saturated with 25 % test item in physiological saline (control group: 0% test item) and placed over the injection sites on the test animals, covered with aluminium foil and firmly secured by elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape for 48 hours.
- No. of exposures: 1
- Test groups: 10 males and 10 females
- Control group: 5 males and 5 females
- Site: clipped dorsal skin from the scapular region, as for intradermal injections
- Frequency of applications: once
- Exposure period: 48 hours
- Concentrations: 25 %
- Duration: days 8 to 10
B. CHALLENGE EXPOSURES: EPIDERMAL APPLICATIONS
- No. of exposures: 2
- Timing of challenge: two and four weeks after the epidermal applications
- Exposure periods: 24 hours
- Test groups: 10 males and 10 females
- Control group: 5 males and 5 females
- Site: left and right flanks
- Concentration: 25 % test item
- Evaluation: 0, 24 and 48 hours after removal of dressing
- Duration: days 22 to 38
I) FIRST CHALLENGE: hair from a 5 x 5 cm area on the left and right flanks of all animals was clipped and a 2 x 2 cm patch of filter paper was saturated with 25 % test item in physiological saline (non-irritant concentration) and applied to the left flank of all animals (test and control) and secured with a dressing for 24 hours. A second 2 x 2 cm patch of filter paper, saturated in vehicle only (physiological saline), was simultaneously applied to the right flanks of all animals. Test sites were assessed for erythema and oedema locally at 0, 24 and 48 hours after the removal of the dressings.
II) SECOND CHALLENGE: hair was re-clipped and a 2 x 2 cm patch of filter paper, saturated with 25 % test item in physiological saline, was applied to the right flank of each test animal with a secured dressing for 24 hours. A second patch of filter paper, saturated with vehicle (physiological saline), was simultaneously applied to the left flank of each test animal. A patch of filter paper saturated in vehicle only (physiological saline) was applied to the left flank of each control animal for 24 hours, and the right flank received no treatment. Test sites were assessed for erythema and oedema locally at 0, 24 and 48 hours after the removal of the dressings. - Challenge controls:
- 1st challenge: controls received same treatment as test animals (application of 25 % test item to the left flank; vehicle to the right flank)
2nd challenge: controls received vehicle to left flank - Positive control substance(s):
- yes
- Remarks:
- dinitrochlorobenzenol (concurrent)
Results and discussion
- Positive control results:
- positive
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- intradermal induction 1% in physiological saline
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified under Regulation 1272/2008
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.