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EC number: 947-395-4 | 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
- Study period:
- June 23, 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study (different from LLNA test) is available.
Test material
- Reference substance name:
- Reaction products of diazotised 3-amino-2-hydroxy-5-nitrobenzenesulphonic acid, coupled with 1,3-diaminobenzene and diazotised sodium 4-aminobenzenesulfonate, metallised with Basic Chromium (III) Sulphate
- EC Number:
- 947-395-4
- Molecular formula:
- not applicable
- IUPAC Name:
- Reaction products of diazotised 3-amino-2-hydroxy-5-nitrobenzenesulphonic acid, coupled with 1,3-diaminobenzene and diazotised sodium 4-aminobenzenesulfonate, metallised with Basic Chromium (III) Sulphate
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
-Source: David Hall Limited, Burton-on-Trent, Staffordshire, U.K
-Age at study initiation: 8-10 weeks
-Weight at study initiation: 305 - 420 g
-Housing: the animaìs were housed in groups of up to four in solid-floor polypropylene cages furnished with softwood shavings.
-Diet: free access to food (Guinea Pig FDI Diet, Special Diet Services Limited, Witham, Essex, U.K.)
-Water: free access to mains tap water
-Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
-Temperature: 20 - 24 °C
-Humidity: 60 - 70 %
-Air changes: 15 changes per hour
-Photoperiod: 12 hours cycle dark/light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5% (w/v)
- Day(s)/duration:
- day 0
- Route:
- intradermal
- Vehicle:
- other: Freund's Complete Adiuvant plus distilled water in the ratio 1:1
- Concentration / amount:
- 5 % (w/v)
- Day(s)/duration:
- day 0
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 75% (w/w)
- Day(s)/duration:
- day 7 for 48 hours
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25% (w/w)
- Day(s)/duration:
- day 21 for 24 hours
- No. of animals per dose:
- PRETEST: 2 per 4 concentrations
TEST GROUP: 20
CONTROL GROUP: 10 - Details on study design:
- RANGE FINDING TESTS
INDUCTION EXPOSURE: INTRADERMAL
Suspensions of the test material in distilled water were tested to determine the highest practicaì level (up to 25 %) that could be intradermally injected and well tolerated both locally and systemically.
INDUCTION EXPOSURE: EPICUTANEOUS
Suspensions of the test material in distilled water were tested to determine the hìghest practical level which did not, produce excessive inflammation on the flank of animals injected with Freund's Complete Adjuvant (Difco Laboratories, Michigan, U.S.A.) at least seven days previously.
CHALLENGE EXPOSURE: EPICUTANEOUS
Suspensions of the test material in distilled water were tested to determine the highest practical level which did not produce inflammation or irritation on the flank of animals iniected with Freund's Complete Adjuvant at least seven days previously.
MAIN STUDY
INDUCTION EXPOSURE: INTRADERMAL
- No. of exposures: 3 x 2 intradermal injections 0.1 ml each
- Exposure period: day 0
- Test groups: 20 females animals
- Control group: 10 females animals
- Site: 40 mm x 60 mm on the shoulder region
- Frequency of applications: single injection
- Concentrations:
Test group
1° site) Freund's Complete Adiuvant plus distjlled water in the ratio 1:1
2° site) 5.0% (w/v) suspension of test material in distilled water
3° site) 5.0% (w/v) suspension of test material in a 1:1preparation of Freund's Complete Adiuvant plus distilled water.
Control group
1° site) Freund's Complete Adiuvant plus distjlled water in the ratio 1:1
2° site) Distilled water
3° site) Freund's Complete Adiuvant plus distilled water.
INDUCTION EXPOSURE: EPICUTANEOUS
-No. of exposures: one
-Day(s) of challenge: day 7
-Test groups: 20 females animals
-Control group: 10 females animals
-Site: 40 mm x 60 mm on the shoulder region
-Concentrations:
Test group: 0.2-0.3 ml at concentration of 75% (w/w)
Control group: 0.5 ml of the vehicle
-Evaluation (hr after challenge): 48 h
-Other: on tested site was covered with a filter paper (WHATMAN No. 4: approximate size 40 mm x 20 mm) which was held in place by a strìp of surgical adhesive tape (BLENDERM: approximate size 60 mm x 25 mm) and covered with an overlapping length of aluminium foil. The patch and foil were further secured by a strip of elastic adhesive bandage (ELASTOPLAST: approximate size 250 mm x 35 mm) wound in a double layer around the torso of each animal
CHALLENGE EXPOSURE
-No. of exposures: one
-Day(s) of challenge: 24
-Exposure period: 24
-Test groups: 20 females animals
-Control group: 10 females animals
-Site: area, approxìmately 50 - 70 x 50 mm on flank
-Concentrations:
Test group
0.1 - 0.2 ml of the test material formulation (25%w/w in distilled water) was applied to the shorn right flank
Control group
Vehicle only
-Other: on tested site was covered with a filter paper (WHATMAN No. 4: approximate size 20 mm x 20 mm) which was held in place by a strìp of surgical adhesive tape (BLENDERM: approximate size 40 x 50 mm). The patches were occluded with an overlappìng length of aluminium foil and secured by a strip of elastic adhesive bandage (ELASTOPLAST: approxìmate size 250 mm x 75 mm) wound in a double layer around the torso of each animal. - Positive control substance(s):
- yes
- Remarks:
- 2,4-DINITROCHLOROBENZENE (DNCB) in a validate study (April 1989)
Results and discussion
- Positive control results:
- The reference substance produced a 79 % (15/19) sensitisation rate. This was considered to be a satisfactory sensitisation response for this material under the conditions of the test.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 % in distilled water (intradermal induction)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No adverse reactions were noted at the test material and vehicle control sites of the test or controì animals at the 24 and 48-hour observations.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 % in distilled water (intradermal induction)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No adverse reactions were noted at the test material and vehicle control sites of the test or controì animals at the 24 and 48-hour observations.
- 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:
- 10
- Clinical observations:
- No adverse reactions were noted at the test material and vehicle control sites of the test or controì animals at the 24 and 48-hour observations.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse reactions were noted at the test material and vehicle control sites of the test or controì animals at the 24 and 48-hour observations.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 % (w/v) (intradermal induction)
- No. with + reactions:
- 15
- Total no. in group:
- 19
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1 % (w/v) (intradermal induction)
- No. with + reactions:
- 9
- Total no. in group:
- 19
Any other information on results incl. tables
PRETEST
-Toxicological signs
Signs of systemic toxicity (lethargy, pallor, hunched posture and emaciation) were noted in the animal intradermally injected with the test material at a concentration of 25% (w/v) in distilled water. This animal was killed for humane reasons 48 hours after injection.
Animals injected wìth the test material at a concentration of l%, 5% or l0% showed no signs of systemic toxicity.
Post mortem examination
Necropsy revealed severe oedema extending over the nuchal, thoracic, abdominal and cervical regions and around the front limbs, accompanied by brown/black discoloration of the subcutaneous tissue.
-Main Study
a) Induction
Brown-coloured staining caused by the test material was noted over the whole treatment site following patch removal after the topical induction period. This did not preclude accurate assessment of the dermal responses.
Scattered mild redness was commonly noted at the test material sites of the test group animals at the one hour observation. Scattered mild or moderate and diffuse redness persisted at the test material sites at the 24 -hour observatjon. No adverse skin reactions were elicited by the vehicle.
b) Challenge
Faint brown-coloured staining was noted at the test material sites of three test group animals at challenge. This did not preclude accurate assessment of the skin responses.
No adverse reactions were noted at the test material and vehicle control sites of the test or controì animals at the 24 and 48-hour observations.
-Bodvweight
Bodyweight gains of guinea pigs in the test group, between day 0 and day 24, were comparable to those observed in the control group animals over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP regulation (EC) no. 1272/2008
- Conclusions:
- The test material was not found to be a sensitiser to guinea pig skin, under the test condition.
- Executive summary:
In order to assess the skin sensitisation potential of the test material an in vivo test to guinea pigs was performed according to the OECD Guideline 406 (1981).
Based on the results of the sighting studies, the concentrations of test material for the induction and challenge phases were selected as follows:
Intradermal Induction: 5% (w/v) in distilled water
Topical Induction: 75% (w/w) in distilled water
Topical Challenge: 25% (w/w) in distilled water
The test material produced a 0 % (0/20) sensitisation rate and was not considered as a sensitiser to guinea pig skin.
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