Registration Dossier
Registration Dossier
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: 255-217-5 | CAS number: 41098-56-0
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to internationally accepted testing guidelines and according to the GLP procedures.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
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:
- The test was performed before the validation of LLNA OECD method and is considered to be valid and acceptable for the assessment.
Test material
- Reference substance name:
- Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-(diethylamino)-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)
- EC Number:
- 255-217-5
- EC Name:
- Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-(diethylamino)-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)
- Cas Number:
- 41098-56-0
- Molecular formula:
- C40H44N12O18S6.6Na
- IUPAC Name:
- hexasodium 2,2'-(ethene-1,2-diylbis{(3-sulfonato-4,1-phenylene)imino[6-(diethylamino)-1,3,5-triazine-4,2-diyl]imino})dibenzene-1,4-disulfonate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland.
- Age at study initiation: males: 7 weeks, females: 8 weeks.
- Weight at study initiation: males: 336 - 461 g, females: 332 - 428 g.
- Housing: single.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: one week.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 40-70 %
- Air changes: 10-15 changes per hour.
- Photoperiod: 12/12 hrs dark / hrs light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: distilled water and petrolatum oil
- Concentration / amount:
- Intradermal induction: 5 %
Cutaneaous induction: 25 %
Challenge: 10 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: distilled water and petrolatum oil
- Concentration / amount:
- Intradermal induction: 5 %
Cutaneaous induction: 25 %
Challenge: 10 %
- No. of animals per dose:
- Control group: 5 male and 5 female
Test group: 10 male and 10 female - Details on study design:
- RANGE FINDING TESTS
The objective of this investigation was to identify irritant test article concentrations suitable for the induction phase of the main study. In addition, a suitable non-irritant concentration of the test article, by the topical route of administration, was identified for the challenge application.
The procedure applied for these investigations was as follows:
_Intradermal injections: intradermal injections (0.1 ml/site) were made into the clipped flank of two guinea-pigs at concentrations of 1, 3 and 5 % of the test article in distilled water. The resulting dermal reactions were assessed 24 hours later.
_Epidermal applications: patches of filter paper ( 2 x 2 cm) were saturated with concentrations of 3, 5, 10 and 25 % of the test article in petrolatum oil and applied to the clipped and shaved flanks of each of four guinea-pigs. The patches were covered by a strip of aluminum foil and firmly secured by elastic plaster wound round the trunk and covered with impervious adhesive tape. This procedure ensured the intensive contact of the test article. The dressings were removed after an exposure period of 24 hours and the reaction sites were assessed for erythema and edema on a numerical basis according to the scale described above. Further examination of the sites were performed 24 and 48 hours after removal of the dressings.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (one intradermal, one epidermal).
- Exposure period: 1 week after intradermal, 48 hours epidermal application.
- Test groups: 5% intradermal application, 25% epidermal application.
- Control group: intradermal with distilled water, epdermal with petrolatum oil.
- Site: scapular region.
B. CHALLENGE EXPOSURE
- No. of exposures: 1 epidermal application.
- Day(s) of challenge: two weeks after epidermal induction.
- Exposure period: 24 hours.
- Test groups: 10 % test article in petrolatum oil, and vehicle alone.
- Control group: 10 % test article in petrolatum oil, and vehicle alone.
- Site: right and left flank.
- Concentrations: 10 %
- Evaluation (hr after challenge): 24 and 48 hours after challenge. - Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitro-benzol (DNCB)
Results and discussion
- Positive control results:
- For the induction period a 0.5 % dilution of DNCB in ethanol, and for the challenge procedure a 0.3 % dilution of DNCB was used.
Positive erythema reaction after first challenge procedure after 24 hours:
postive: 6 animals; negative: 3 animals
67 % with positive reaction
According to the results observed it is considered that DNCB possess a strong skin sensitizing (contact allergenic) potential in the guinea pig strain used (Dunkin-Hartley albino guinea pigs; DUHA KFM. Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.3%
- No. with + reactions:
- 6
- Total no. in group:
- 9
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as a skin sensitiser according to the CLP Regulation
- Conclusions:
- Not sensitising.
- Executive summary:
Method
A sensitization test in guinea pigs was performed to determine the contact allergenic potency of the test compound. The test was performed according to the OECD Guideline No. 406.
Results
According to the results a weak allergenic potency of the test article was observed in this test when followed the rating of allergenicity described by Magnusson B. and Kligman A.M. (1969).
Conclusion
According to the CLP Regulation, the results showed that test articol is not a skin sensitizer.
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.