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EC number: 241-164-5 | CAS number: 17095-24-8
- 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:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Directive 96/54/EEC
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- not specified
- Justification for non-LLNA method:
- Not specified
Test material
- Reference substance name:
- -
- EC Number:
- 432-100-9
- EC Name:
- -
- Molecular formula:
- C78H58N15Na13O58S19
- IUPAC Name:
- reaction mass of: pentasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-{(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}naphthalene-2,7-disulfonate; tetrasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate; tetrasodium 4-amino-5-hydroxy-6-{(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-3-[(E)-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: unknown
- Expiration date of the lot/batch: unknown
- Purity test date: unknown
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: unknown
- Specific activity: unknown
P a g . 3 | 13
- Locations of the label: unknown
- Expiration date of radiochemical substance: unknown
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: unknown
- Stability under storage conditions: unknown
- Stability under test conditions: unknown
- Solubility and stability of the test substance in the solvent/dispersant/vehicle/test medium:
The vehicle is bi-distilled water. Solubility of test material in water is 506000 mg/L (at 20°C).
- Reactivity of the test substance with the solvent/vehicle /test medium (if applicable): unknown
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: test material is diluted in bi-distilled water for the second intradermal injection, topical application and challenge; test material is diluted in physiological saline plus FCA for the third intradermal injection.
- Preliminary purification step (if any): unknown
- Preparation of a nanomaterial dispersion (incl. dilution): unknown
- Final dilution of a dissolved solid, stock liquid or gel: for intradermal injection and challenge, final dilution is 5% and 15% respectively; for topical application, final dilution is 50%.
- Final preparation of a solid: unknown
- FORM AS APPLIED IN THE TEST (if different from that of starting material): test material is applied as liquid form in intradermal and topical injections, while in the challenge, it is loaded on a patch.
INFORMATION ON NANOMATERIALS
- Chemical Composition: unknown
- Density: unknown
- Particle size & distribution: unknown
- Specific surface area: unknown
- Isoelectric point: unknown
- Dissolution (rate): unknown
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable): unknown
OTHER SPECIFICS
- measurement of pH, osmolality, and precipitate in the culture medium to which the test chemical is added: unknown
- other information: no other information
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- not specified
- Details on test animals and environmental conditions:
- 10 animals for test group
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- Even if the detailed procedure of the study is not described in the analytical report of Navy MGI 1319, the details on study design reported below refer to Directive 92/69 EEC.
Induction:
1- Intradermal application: Three pairs of intradermal injections of 0.1 ml volume are given in the shoulder region which is cleared of hair.
First injection: physiological solution plus FCA (1:1)
Second injection: test material diluted to 5% in bi-distilled water
Third injections: test material diluted to 5% in physiological solution plus FCA (1:1)
Injections 1 and 2 are given close to each other and nearest the head, while 3 is given towards the caudal part of the test area.
For the control animals, the second and third injections are performed with vehicle only
2- Topical application: The test area is cleared of hair. A filter paper is fully-loaded with test substance diluted to 50% in bi-distilled water and applied to the test area and held in contact by an occlusive dressing for 48 hours.
Challenge:
The flanks of animals are cleared of hair. A patch or chamber loaded with the test substance, diluted to 15% in bi-distilled water, is applied to one flank of the animals and, when relevant, a patch or chamber loaded with the vehicle only may also be applied to the other flank. The patches are held in contact by an occlusive dressing for 24 hours.
Only one challenge is performed. The evaluation of reactions is assessed at 24h and 48h after challenge
No. of animals per dose: 10 animals for test group and 5 animals for control group
Challenge controls: 10 animals for test group and 5 animals for control group
Positive control substance(s): not reported - Challenge controls:
- 10 animals for test group and 5 animals for control group
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Not specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Not specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Not specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Not specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Not specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Not specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Not specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Not specified
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 15% Signs of irritation during induction: No animals showed Oedema after induction. The determination of erythema was not possible due to the blue coloration of the treated skin. No evidence of sensitization at challenge
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not a skin sensitizer
- Executive summary:
An in vivo test was conducted according to the EU B.6 test method (96/54/EEC) to assess the skin sensitization potential of the test material Navy MGI 1319 (EC 432-100-9).
Test group and negative control animals were treated as follows:
- Intradermal injection of the test substance at final concentration of 5% in the vehicle for the test group and intradermal injection of the vehicle only for the control group
- Topical application of the test substance at final concentration of 50% in the vehicle
- Challenge of the test substance at final concentration of 15% in the vehicle
The concentration of test substance used for the induction exposure should be well-tolerated systemically and should be the highest to cause mild-to-moderate skin irritation, while the concentration used for the challenge exposure should be the highest non-irritant dose. The appropriate concentrations can be determined from a pilot study.
In the present study, the maximum concentration not causing irritating effects in preliminary test was 15%. During induction no animals showed signs of irritation and determination of erythema was not possible due to the blue coloration of the treated skin.
For the evaluation of challenge patch test reactions, MAGNUSSON AND KLIGMAN grading scale has been considered:
0 = no visible change
1 = discrete or patchy erythema
2 = moderate and confluent erythema
3 = intense erythema and swelling
No evidence of sensitization was seen at challenge: Navy MGI 1319 (EC 432-100-9) was not considered a skin sensitizer.
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