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EC number: 947-603-3 | 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:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- data is from experimental report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the allergic contact sensitization potential of the given test chemical by the ear/flank method in the guinea-pig.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment
Test material
- Reference substance name:
- octasodium 2,2'-[(2,2'-disulphonato[1,1'-biphenyl]-4,4'-diyl)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino(1-hydroxy-3-sulphonatonaphthalene-6,2-diyl)azo]]bisnaphthalene-1,5-disulphonate
- Cas Number:
- 68110-30-5
- Molecular formula:
- C58H30Cl2N14Na8O26S8
- IUPAC Name:
- octasodium 2,2'-[(2,2'-disulphonato[1,1'-biphenyl]-4,4'-diyl)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino(1-hydroxy-3-sulphonatonaphthalene-6,2-diyl)azo]]bisnaphthalene-1,5-disulphonate
- Test material form:
- solid
- Details on test material:
- Name of the test chemical: Octasodium 2,2'-[(2,2'-disulphonato[1,1'-biphenyl]-4,4'-diyl)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino (1-hydroxy-3-sulphonatonaphthalene-6,2-diyl)azo]]bisnaphthalene-1,5-disulphonate
Molecular formula: C58H30Cl2N14Na8O26S8
Molecular weight: 1850.3 g/mol
Smiles Notation: [Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].c1(c(cc(cc1)Nc1nc(nc(n1)Cl)Nc1cc2cc(c(c(c2cc1)O)\N=N\c1c(c2cccc(c2cc1)S(=O)(=O)[O-])S(=O)(=O)[O-])S(=O)(=O)[O-])S(=O)(=O)[O-])c1c(cc(cc1)Nc1nc(nc(n1)Cl)Nc1cc2cc(c(c(c2cc1)O)\N=N\c1c(c2cccc(c2cc1)S(=O)(=O)[O-])S(=O)(=O)[O-])S(=O)(=O)[O-])S(=O)(=O)[O-]
InChI: 1S/C58H38Cl2N14O26S8.8Na/c59-53-65-55(61-27-7-11-31-25(19-27)21-45(105(89,90)91)47(49(31)75)73-71-39-17-15-35-37(51(39)107(95,96)97)3-1-5-41(35)101(77,78)79)69-57(67-53)63-29-9-13-33(43(23-29)103(83,84)85)34-14-10-30(24-44(34)104(86,87)88)64-58-68-54(60)66-56(70-58)62-28-8-12-32-26(20-28)22-46(106(92,93)94)48(50(32)76)74-72-40-18-16-36-38(52(40)108(98,99)100)4-2-6-42(36)102(80,81)82;;;;;;;;/h1-24,75-76H,(H,77,78,79)(H,80,81,82)(H,83,84,85)(H,86,87,88)(H,89,90,91)(H,92,93,94)(H,95,96,97)(H,98,99,100)(H2,61,63,65,67,69)(H2,62,64,66,68,70);;;;;;;;/q;8*+1/p-8/b73-71+,74-72+;;;;;;;;
Substance Type: Organic
Physical State: Solid
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
- Weight at study initiation: weight range of 278 - 342 g,
- Housing: All animals were maintained in galvanized plasticized cages with solid floors
- Diet (e.g. ad libitum): complete pelleted guinea-pig diet supplemented daily with autoclaved hay, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- N,N-dimethylformamide
- Concentration / amount:
- 0.1 ml of 10% w/v suspension in 50% aqueous DMF
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- N,N-dimethylformamide
- Concentration / amount:
- 0.05 ml of 10,1, 0.1% w/v suspension in 50% aqueous DMF
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10
6 -test group
4- control group - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 24 hours
- Test groups: 6
- Control group: 4
- Site: outer surface of the ears
- Frequency of applications: daily for 3 days
- Duration: 24hours
- Concentrations: 0.1ml of 10% w/v suspension in 50% aqueous dimethylformamtde (DMF)
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: 1 day
- Exposure period: 24 hours
- Test groups: 6
- Control group: 4
- Site: clipped flanks
- Concentrations: 10%, 1% and 0.1% w/v suspensions in 50% aqueous DMF
- Evaluation (hr after challenge): 24 hours after exposure
OTHER: On Day 7, any erythema which develops at each site was rated on a 5-point scale. Amongst the pre-treated animals, only erythema in excess of that present in the controls was considered to denote sensitization; that present in the controls denotes simple primary irritation. - Challenge controls:
- no data available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%, 1% and 0.1% w/v suspensions in 50 0/1 aqueous DMF
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- No reactions observed
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Distribution and rating of signs of skin sensitization responses among individual guinea pigs exposed to induction and challenge procedures to detect delayed contact sensitization by the test chemicalafter challenge at 0.1,1 and 10% w/v DMF
Treatment |
Observations |
Animal numbers |
Ratio of test animals showing response on Day 7 |
||||||||||
Test |
Control |
||||||||||||
1, male |
2 male |
3 male |
1, female |
2 female |
3, female |
4, male |
5, male |
4, female |
6, female |
|
|||
|
Bodyweight (g) |
|
|
|
|
|
|
|
|
|
|
|
|
INDUCTION |
278 |
320 |
295 |
319 |
342 |
310 |
290 |
330 |
304 |
309 |
|
||
Day 7 |
312 |
367 |
298 |
346 |
383 |
351 |
372 |
354 |
348 |
339 |
|
||
Increment |
34 |
47 |
3 |
27 |
41 |
41 |
82 |
24 |
44 |
30 |
|
||
Challenge, 0.1% |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/6 |
|
Challenge, 1% |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/6 |
|
Challenge, 10% |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/6 |
|
No response = 0
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- No responses were provoked during induction or after challenge exposure by the test chemical. Animals showed normal body weight changes and remained in good health throughout the study. Under the conditions of the study, test chemical displayed no strong allergic contact sensitization potential and it can be considered to be not sensitizing to skin.
- Executive summary:
The allergic contact sensitization potential of the test chemical was assessed by the ear/flank method in the guinea-pigs. Ten Dunkin-Hartley male and female guinea-pigs were used for this test. On Days 0, 1, and 2 of the test, 0.1ml of 10% w/v suspension in 50% aqueous dimethylformamtde (DMF) was applied to the outer surface of the ears of six animals only. On Day 6, 0.05 ml of 10%, 1% and 0.1% w/v suspensions in 50% aqueous DMF was applied topically to the clipped flanks of all ten animals. On Day 7, any erythema which develops at each site was rated on a 5-point scale. Amongst the pre-treated animals, only erythema in excess of that present in the controls was considered to denote sensitization; that present in the controls denotes simple primary irritation. No responses were provoked during induction or after challenge exposure by the test chemical. Animals showed normal bodyweight changes and remained in good health throughout the study. Under the conditions of the study, test chemical displayed no strong allergic contact sensitization potential and it can be considered to be not sensitizing to skin.
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