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EC number: 274-397-6 | CAS number: 70209-99-3
- 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:
- 15 Oct, 1985 to 26 Nov, 1985
- 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:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- no
- 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:
- Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- EC Number:
- 274-397-6
- EC Name:
- Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- Cas Number:
- 70209-99-3
- Molecular formula:
- C23H16BrN3O9S2.2Na
- IUPAC Name:
- disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test substance: FAT 4006 8/C
Batch No.: EN 86'527.22
Contents of active ingredients: 70.0%
Physical properties: powder
Storage conditions: room temperature
Stability: guaranteed by the sponsor
Validity: April 1990
Test material received: May 15, 1985
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Identified as: FAT 40068/C
- Source and batch no.of test material: EN 86527.22
- Expiration date of the batch: April, 1990
- Contents of active ingredient: 70 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Guaranteed by the sponsor
OTHER SPECIFICS:
- Physical properties: Powder
- Safety precautions: Gloves and face masks
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: approx. 10 weeks old
- Weight at study initiation: 315 - 439 g
- Housing: Individually in Macrolon cages (Type 3)
- Diet: ad libitum standard guinea pig pellets - NAFAG No.846, Gossau SG
- Water: ad libitum fresh water
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity: 30 to 70 %
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day.
- IN-LIFE DATES: From: October 15, 1985 To: November 15, 1985
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5 %
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 30 %
- Day(s)/duration:
- Day 8
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 1 %
- Day(s)/duration:
- Day 22
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 males and 10 females
- Details on study design:
- RANGE FINDING TESTS: The concentration of the test compound for the induction and challenge periods were determined on separate animals.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Two (1 intradermal + 1 epicutaneous)
- Exposure period: First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later for 24 hours.
- Site: Intradermal induction- Shaved neck of the guinea pigs, epicutaneous induction- neck of the animals previuosly used for intradermal induction.
- Frequency of applications: Once each for intradermal and epicutaneous inductions
- Duration: epicutaneous induction- 48 hours
- Concentrations: intradermal induction - 5 %, epicutaneous induction: 30 %
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Two weeks after the epidermal induction application
- Exposure period: 24 hours
- Site: On the flank
- Concentrations: 1 %
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test compound (at least 10 animals) to control the maximal subirritant concentration of the test compound in adjuvant treated animals.
- Positive control substance(s):
- yes
- Remarks:
- The sensivity of the strain is checked every six months with Paraphenylene-diamine or Potassium-dichromate.
Results and discussion
- Positive control results:
- Not specified
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% Intradermal and 30% Epicutaneous induction. 1% Epidermal challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% Intradermal and 30% Epicutaneous induction. 1% Epidermal challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was classified as a non-sensitiser.
- Executive summary:
A study was conducted to evaluate the skin sensitisation potential of the test substance as per the maximization test recommended in the OECD Guideline 406 and EEC directive 79/83. The test was performed on 10 male and 10 female guinea pigs per group weighing between 315-439 g (approx. 10 weeks old). The induction was a two-stage operation: First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later. For intradermal induction, the test substance was administered at the concentration of 5% in physiological saline and adjuvant mixture. For epicutaneous induction, approximate 0.4 g paste of 30% test substance in vaseline was applied. Two weeks after the epidermal induction application the animals were challenged on the flank with approximate 0.2 g paste of 1 % test substance in vaseline and the vehicle alone (patch 2 x 2 cm; occluded administration for 24 hours). Twenty four hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. A second evaluation was made 48 hours after removing the dressings. Under the experimental conditions employed, 0 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. Hence, based on the findings of the study, the test substance was classified as a non-sensitiser.
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