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EC number: 277-554-7 | CAS number: 73612-40-5
- 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)
- Remarks:
- points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo studies can still be used to fulfil the information requirement at any tonnage level.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From the 31th January to the 17th of May, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Test conducted according to internationally accepted testing guidelines
- Justification for type of information:
- points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo studies can still be used to fulfil the information requirement at any tonnage level.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo studies can still be used to fulfil the information requirement at any tonnage level.
Test material
- Reference substance name:
- Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxybenzenesulphonamidato(2-)]cobaltate(1-)
- EC Number:
- 277-554-7
- EC Name:
- Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxybenzenesulphonamidato(2-)]cobaltate(1-)
- Cas Number:
- 73612-40-5
- Molecular formula:
- C32H24Cl2CoN10NaO8S2
- IUPAC Name:
- sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxybenzenesulphonamidato(2-)]cobaltate(1-)
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
Breeder: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
Date of acclimatisation: January 26, 1994
Weight at study initiation: 324 -403 g
Housing: Macrolon cages (type 3), assigned to the different groups by means of random numbers generated by the random number generator, identified by individually numbered ear tags.
Diet: rat food -NAFAG 845, Gossau SG, ad libitum
Water: ad libitum. The quality of the drinking water was according to the specification "Schweizerisches Lebensmittelbuch" (Edition 1972)
All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer. Analytical results available.
Acclimatization: 5 days
ENVIRONMENTAL CONDITIONS
Temperature: 22°C (+/- 3°)
Humidity: 30-70 %
Photoperiod (hrs dark / hrs light): 12 hours light
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- PRETEST
Intradermal induction: 5%
Epidermal application: 10, 20, 30, 50%
TEST
Intradermal induction: 5%
Epidermal application: 50%
Challenge: 20% - Day(s)/duration:
- 2
- Adequacy of induction:
- not specified
Challenge
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- PRETEST
Intradermal induction: 5%
Epidermal application: 10, 20, 30, 50%
TEST
Intradermal induction: 5%
Epidermal application: 50%
Challenge: 20% - Day(s)/duration:
- 2
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Minimum number of animals (5 per sex for the test group and 5 of one sex for controls).
After the challenge procedure, it was not possible to conclude if the test substance is a sensitizer or not and therefore testing in additional animals was performed to give a total of 20 test and 10 control animals. - Details on study design:
- Auxiliary compounds:
Physiological saline (0.9 %), sterile solution (Hausmann, St. Gallen, Switzerland) Bacto Adjuvant, Complete, Freund (Difco Lab. Detroit Michigan USA)
TEST PROCEDURE
DAY 0: INDUCTION, intradermal injections
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the left and right side of the shaved neck of the test and control group animals.
Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5% in physiological saline (w/v)
- 5% in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- physiological saline
DAY 8: INDUCTION, epidermal application
In the test group was incorporated in physiological saline and applied on a filterpaper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g per patch; occluded administration for 48 hours).
The control group was treated with the vehicle only.
Test group:
- 50% in physiological saline
Control group:
- physiological saline only
DAY 21: Challenge
The test and control group animals were tested on one flank in physiological saline and on the other flan with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 24 hours).
Test and control group:
- 20% in physiological saline
- physiological saline only
OBSERVATION
Induction reactions
After the intradermal and the epidermal induction application irritant reactions are normally induced by the adjuvant and the high concentration.
Challenge reactions
Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale.
General
The body weight was recorded at start and at the end of the test.
EVALUATION OF RESULTS
grading of Magnusson and Kligman. According to the guide to the labelling of dangerous substances Commission Directive 93/21/EEC, April 27, 1993) a test article was classified as a sensitiser in the case where a positive response was noted in at least 30 % of the animals. - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzotriazole
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30 and 50% of the substance in physiological saline
- No. with + reactions:
- 2
- Total no. in group:
- 20
Any other information on results incl. tables
PRETEST
Intradermal reaction: since 5% of substance in physiological saline could be injected and was well tolerated, this concentration was used for the intradermal induction.
Epidermal application: reactions were observed with 30 and 50% of the substance in physiological saline.
Body weights were not affected by treatment.
Under the experimental conditions employed, 10% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings.
The substance is , therefore, classified as a mild sensitiser in albino guinea pigs according to the grading of Magnusson and Kligman.
Sensitization rate %
Grade I: 0 - 8 weak
Grade II: 9 - 28 mild
Grade III: 29 -64 moderate
Grade IV: 65 - 80 strong
Grade 81 -100: extreme
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Classification criteria according to the CLP Regulation 1272/2008 and its amendments
- Conclusions:
- Mild grade of skin sensitizing (contact allergenic) potential in albino guinea pigs (maximisation grading of Magnusson and Kligman)
- Executive summary:
The test was carried out according to the method OECD 406, in GLP. The evaluation of the reactions was done according to the maximisation grading of Magnusson and Kligman.
At first, a pre test was performed with intradermal induction and an epidermal application, to define the concentration to be used during the test.
The main test procedure included an induction, with an intradermal injection and an epidermal application, and a challenge (patch application).
After the intradermal and the epidermal induction application irritant reactions are normally induced by the adjuvant and the high concentrations.
24 and 48 hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale.
The body weight was recorded at start and at the end of the test.
Under the experimental conditions employed, 10% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings.
The substance showed a mild grade of skin-sensitizer (contact allergenic) potential in albino guinea pigs, following the maximisation grading of Magnusson and Kligman.
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