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Reaction mass of Cobaltate(2-), [2-[[[4-hydroxy-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]sulfonyl]amino]benzoato(3-)][2-[[2-hydroxy-5-[(phenylamino)sulfonyl]phenyl]azo]-3-oxo-N-phenylbutanamidato(2-)]-, disodium and Cobaltate(3-), bis[2-[[[4-hydroxy-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]sulfonyl]amino]benzoato(3-)]-, trisodium and sodium bis[2-[[2-hydroxy-5-[(phenylamino)sulphonyl]phenyl]azo]-3-oxo-N-phenylbutyramidato(2-)]cobaltate(1-)
EC number: 947-257-3 | 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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Old test
Test material
- Reference substance name:
- Acid Yellow 235
- IUPAC Name:
- Acid Yellow 235
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Housing: 5 animals were housed in each cage.
- Diet: a standard laboratory diet was provided, ad libitum. The batch of the diet used for the study was analysed for ctremical and microbiological contaminants.
- Acclimation period: all animals were acclimatized to the environment for a period of seven days prior to the start of the study.
- Indication of any skin lesions: 24 hours prior to the test, the skin of the back was clipped by means of an electric clipper and the skin was investigated for pre-existing injuries. This was repeated on days 7 and 22. The skin was cleaned with 10 % sodium laurylsulfate on day 7.
ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 1 °C
- Relative humidity: 50 ± 5 %
- Air changes: approx. 10-15 air changes per hour.
- Photoperiod: 12 hrs dark / 12 hrs Iight.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 5 %
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5 %
- No. of animals per dose:
- 20 animals per group
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal injection
- No. of exposures: test was started with three intradermal paired injections.
Epicutaneous
- Application: a patch (25 cm2) soaked with 3 mI was fixed on the clipped backs.
- Exposure period: 48 hours
- Control group: only water or adjuvant were used.
B. CHALLENGE EXPOSURE
- Day(s) after start: 21
- Exposure period: 24 hours
- Evaluation: after 24 and 48 hours respectively, the patches were removed and the resulting reactions were evaluated. - Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 3 ml water
- No. with + reactions:
- 0
- Total no. in group:
- 20
Any other information on results incl. tables
The test item administered to guinea pigs, according to the maximization test, resulted in no reaction after 24, 48 and 72 hours respectively. In contrast, DNCB, a well known sensitizer, was positive after 24, 48 and 72 hours.
It can be concluded that test substance was not a sensitizer.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- Not skin sensitising
- Executive summary:
60 guinea pigs were divided in three groups, 20 animals each group: one group was treated with test item; another with 1-chloro-2,4-dinitrobenzene (DNCB) as a positive control and the third group served as negative controls, treated with water and Freuds Adjuvant alone.
Test substance was dissolved with water or Adjuvant respectively to 5 % solution, which was used for the paired injection on day 1 of the study. The test was started with three intradermal paired injections; on day 8, a patch (25 cm2) soaked with 3 ml was fixed for 48 hours on the clipped backs. 21 days after the start, the flanks of the animals were clipped and on the next day a patch was fixed for 24 hours, using test item 3 ml of the 5 % solution for the treated and negative control animals.
After 24 or 48 hours respectively, the patches were removed and the resulting reactions were evaluated.
The test item administered to guinea pigs, according to the maximization test, resulted in no reaction after 24, 48 and 72 hours respectively. In contrast, DNCB, a well known sensitizer, was positive after 24, 48 and 72 hours.
It can be concluded that test substance was not a sensitizer.
Conclusion
Less than ≥ 30 % of exposed population, showed positive reactions at intradermal induction dose higher than 1 %.
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