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EC number: 279-317-3 | CAS number: 79828-43-6
- 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
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Annex V, Part B of Council Directive 79/831/EEC
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Data from a reliable in vivo test conducted before the enforcement of Commission Regulation (EU) 640/2012 of 06 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are available.
Test material
- Reference substance name:
- Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)
- EC Number:
- 279-317-3
- EC Name:
- Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)
- Cas Number:
- 79828-43-6
- Molecular formula:
- C38H18Cl2CrN16O20S4.5Na
- IUPAC Name:
- Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Pirbright white strain (Tif: DHP),
10 male and 10 female animals were used in the test group and 5 male and 5 female in the control group, respectively. (initial weight was between 336 to 418 g).
The animals were housed individually in Macrolon cages(Type 3), assigned to the different groups by means of random numbers generated by the random number generator, identified by individual ear tags, kept at a constant room temperture of 22 ± 3 °C, at a relative humidity of 30 to 70 % and a 12 hours light cycle day. The animals received ad libitum standard guinea pig pellets and fresh water.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- 5 % FAT40210/D in physiological saline
- Day(s)/duration:
- Week 1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 40 % in Vaseline in epidermal induction.
- Day(s)/duration:
- One week after intradermal induction (week 2)
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 40 % in Vaseline in epidermal challenge.
- Day(s)/duration:
- Week 5
- No. of animals per dose:
- 20
- Details on study design:
- 0.1 ml of adjuvant /saline mixture, FAT 40210/D in physiological saline and FAT 40210/D in the adjuvant/saline mixture were injected simultaneously intradermal in to the shaved neck of the guinea pigs, and second induction was one week later with FAT 40210/D in vaseline was applied on a filter paper patch to the neck of the animals (patch 2x4 cm, approx 0.4 g paste per patch, occluded administration for 48 hours. Week 5, the animals were tested on the flank with FAT 40210/D in vaseline was applied (patch 2x2 cm, approx. 0.2 g paste per patch, occluded administration for 24 hours).
- Challenge controls:
- The group was treated with the vehicle as well as with the test articles to check the maximum subirritant concentration of the test article in adjuvant treated animals.
- Positive control substance(s):
- yes
- Remarks:
- strain sensitivity is tested once or twice per year with a known sensitizer (e.g. mercaptobenzothiazole, hexyl cinnamic aldehyde or potassium dichromate). Results of last three tests included in report.
Results and discussion
- Positive control results:
- None
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 40 % in Vaseline
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: (test article control)
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 40 % in Vaseline
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: (test article control)
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0 (vehicle control)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0 (vehicle control)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40 % in Vaseline
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40 % in Vaseline
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Potassium dichromate ( Intradermal induction: 0.2%, Epidermal induction: 5%, Epidermal Challenge: 1%)
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- other: No reactions were seen with the side with vehicle only exposure
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- FAT 40210/D was found to be a strong sensitizer in albino guinea pigs testing.
- Executive summary:
A key study was performed to determined skin sensitisation of FAT 40210 according to OECD Guideline 406 (Skin Sensitisation).
75 % and 65 % of the animals were sensitized by FAT 40210/D in the test group following challenge. And according to the maximization grading FAT 40210/D showed a strong grade of skin-sensitizing (contact allergenic) potential in albino guinea pigs, which shall be classified as skin sensitizer 1B according to CLP Regulation (Regulation EC No. 1272/2008).
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