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EC number: 916-918-8 | 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:
- From July 16, 1979 to September 6, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Maurer Optimization test in the guinea-pig
- Version / remarks:
- - Maurer Th., Thomann P., Weirich E.G., Hess R. - The Optimization test in the guinea-pig. Agents & Actions 5 (2), 174-179, 1975.
- Predictive evaluation in animals of the contact allergenic potential of medically important substances. Contact Dermatitis 4, 321-333, 1978. Contact Dermatitis 5, 1-10, 1979.
- GLP compliance:
- no
- Type of study:
- Maurer optimisation test
- Justification for non-LLNA method:
- Study predates LLNA method
Test material
- Reference substance name:
- Bis[5-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)
- EC Number:
- 281-692-3
- EC Name:
- Bis[5-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)
- Cas Number:
- 84012-52-2
- Molecular formula:
- C36H42Cl4N12Zn
- IUPAC Name:
- bis[5-({4-[benzyl(methyl)amino]phenyl}diazenyl)-1,4-dimethyl-4,5-dihydro-1H-1,2,4-triazol-1-ium] tetrachlorozincate(2-)
- Reference substance name:
- Bis[3-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)
- EC Number:
- 281-650-4
- EC Name:
- Bis[3-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)
- Cas Number:
- 84000-94-2
- Molecular formula:
- C36H42Cl4N12Zn
- IUPAC Name:
- bis(3-[(E)-2-{4-[benzyl(methyl)amino]phenyl}diazen-1-yl]-1,4-dimethyl-1H-1,2,4-triazol-4-ium); tetrachlorozincdiuide
- Test material form:
- solid: particulate/powder
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other:
- Remarks:
- Pirbright-White
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:Ivanovas, Kissleg (later Charles River Kissleg), Germany
- Age at study initiation: ~10 weeks old
- Weight at study initiation: 375 to 485 g
- Housing: housed individually in Macrolon cages, type 3, assigned to the different groups by means of random numbers.
- Diet : The animals received ad libitum standard guinea pig pellets - NAFAG, N°. 830 supplemented with fresh carrots.
- Water: ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C
- Humidity (%): 55± 5%
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 10 * 0.1 ml of 0.1 % of test substance every other day (except weekends)
During the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant (Freund's complete Adjuvant) (vehicle : adjuvant =1 : 1). - Day(s)/duration:
- Days 1, 3, 5, 9, 11, 13, 17, 19, 21, 25
Challengeopen allclose all
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- physiological saline
- Remarks:
- complete Bacto Adjuvant
- Concentration / amount:
- 0.1 ml of a freshly prepared 0.1 % solution
- Day(s)/duration:
- 14 days after last induction injection
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 3 % of test item in vaseline
- Day(s)/duration:
- 10 days after intradermal challenge for 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 per sex per dose
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE INTRADERMAL
- No. of exposures: the animals received one injection every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1 % suspension of test item in physiological saline. During the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant (vehicle : adjuvant = 1 : 1)
- Test groups: 10 males and 10 females guinea pigs
- Control group: 10 males and 10 females guinea pigs, one control group was treated with the vehicle alone
- Site: shaven skin of the right flank (only day 1) and the back
- Frequency of applications: every second day
- Duration: 10 intracutaneous injections (approximately 25 days)
- Concentrations: 0.1 % solution of test substance
B. CHALLENGE EXPOSURE
INTRADERMAL
- No. of exposures: single injection of 0.1 ml
- Day(s) of challenge: Fourteen days after the last induction injection
- Exposure period: single injection
- Test groups: 10 males and 10 females guinea pigs
- Control group: 10 males and 10 females guinea pigs
- Site: skin of the left flank
- Concentrations: 0.1 % solution of test substance in physiological saline
- Evaluation (hr after challenge): Twenty-four hours after the challenge injection
EPIDERMAL
- No. of exposures: one
- Day(s) of challenge: ten days after the challenge injection
- Exposure period: 24 h
- Test groups: 10 males and 10 females guinea pigs
- Control group: 10 males and 10 females guinea pigs
- Site: skin of the left flank
- Concentrations: 3 % of test substance in vaseline
- Evaluation (hr after challenge): Twenty-four hours after patch removal
OTHER:
Bodyweights were recorded immediately before starting the experiment (control values) and at termination of the study. - 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:
- 0.1 ml of 0.1 % test item in physiological saline
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: intradermal challenge
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30% of test item in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- epidermal challenge
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
Any other information on results incl. tables
No difference between the test and the control group was seen after epidermal challenge application.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The negative results upon epidermal challenge demonstrate that, in artificially sensitised guinea-pigs, exposure of the intact skin to the test compound does not provoke contact dermatitis. The substance is not considered to be a skin sensitiser.
- Executive summary:
Under the experimental conditions employed, significant differences between the test group and the vehicle treated controls were only seen after intradermal challenge application of test substance, i.e. when the skin barrier was intentionally by-passed. No difference between the test and the control group was seen after epidermal challenge application. The negative results upon epidermal challenge demonstrate that, in artificially sensitized guinea-pigs, exposure of the intact skin to the test compound does not provoke contact dermatitis.
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