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EC number: 915-761-2 | 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:
- October 5, 1993 to December 10, 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- 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:
- 3(or5)-[[4-[benzylmethylamino]phenyl]azo]-1,2(or1,4)-dimethyl-1H-1,2,4-triazolium bromide
- EC Number:
- 289-660-0
- EC Name:
- 3(or5)-[[4-[benzylmethylamino]phenyl]azo]-1,2(or1,4)-dimethyl-1H-1,2,4-triazolium bromide
- Cas Number:
- 89959-98-8
- Molecular formula:
- C18H21N6.Br
- IUPAC Name:
- Reaction mass of 3-[{4-[Benzyl(methyl)amino]phenyl}diazenyl]-1,4-dimethyl-4H-1,2,4-triazol-1-ium bromide and 5-[{4-[Benzyl(methyl)amino]phenyl}diazenyl]-1,4-dimethyl-4H-1,2,4-triazol-1-ium bromide
Constituent 1
- Specific details on test material used for the study:
- - Test Article: FAT 31016/P
- Additional specification: Maxilonrot GRL BR,ro trocken
- Batch No.: 414154.32
- Contents/Purity: 95%
- Physical properties: solid; red-brown powder
- Storage conditions: room temperature
- Validity: July, 1998
- Test article received: September 1, 1993
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 Limited, Animal Production, 4332 Stein / Switzerland
- Weight at study initiation: 327 to 391 g
- Housing: individually in Macrolon cages
- Diet: standard guinea pig pellets - NAFAG No. 845, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3 °C
- Humidity: 30 to 70%
- Photoperiod: 12 hours light cycle day
- IN-LIFE DATES: From: October 11, 1993 To: November 5, 1993
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5%
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- other: this concentration was well tolerated when injected intradermally
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 50 %
- Day(s)/duration:
- Day 8
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 50 %
- Day(s)/duration:
- Day 22
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 males and 10 females in the test groups
5 males and 5 females in the control group - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE - Intradermal
- No. of exposures: 1
- Site: neck
- Frequency of applications: once only
- Concentrations: 5 %
B. INDUCTION EXPOSURE - Epidermal
- No. of exposures: 1
- Site: neck
- Frequency of applications: once only
- Concentrations: 50 %
- Exposure period: 48 hours
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 22
- Exposure period: 24 hours
- Site: flanks
- Concentrations: 50 %
- Evaluation (hr after challenge): 24 and 48 hours after removing the dressings - Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole puriss
Results and discussion
- Positive control results:
- 90 % of the exposed animals exhibited positive reactions.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %: intradermal induction, 50 %: epidermal induction, 50 %: epidermal challenge
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %: intradermal induction, 50 %: epidermal induction, 50 %: epidermal challenge
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- 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
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Intradermal induction: 5 %, epidermal induction: 50 % and epidermal challenge: 30%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Intradermal induction: 5 %, epidermal induction: 50 % and epidermal challenge: 30%
- No. with + reactions:
- 9
- Total no. in group:
- 10
Any other information on results incl. tables
Under the experimental conditions employed, 100% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- FAT 31016/P was found to have strong sensitisation potential in the Guinea Pig Maximisation Test.
- Executive summary:
A sensitisation test in albino guinea pigs was performed to determine the contact allergenic potency of FAT 31016/P. This test was based on the OECD Guideline No. 406, adopted May 12, 1981, adapted July 17, 1992, by the OECD council, and on Annex V, Part B of Council Directive 67/548/EEC (Commission Directive 92/69/EEC of July 31, 1992).
The test was performed on 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group, respectively, initially weighing between 327 to 391 g. The test group animals were given test substance at 5 % (in physiological saline) during the intradermal induction phase, while exposed to 10 % SDS + 50 % test substance (in Vaseline) at the epidermal induction phase. The test as well as control animals were then challenged with a epidermal application of the test substance at 50 % concentration (in Vaseline). Under the experimental conditions employed, 100 % (20/20) of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. Hence, FAT 31016/P was concluded to have strong sensitisation potential in the Guinea Pig Maximisation Test.
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