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EC number: 437-970-3 | CAS number: 371921-62-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA-skin sensitisation study does not need to be conducted because adequate data from an in vivo (non-LLNA) study is already available.
Test material
- Reference substance name:
- Red 0106-PP1
- IUPAC Name:
- Red 0106-PP1
Constituent 1
In vivo test system
Test animals
- Species:
- other: Guinea pigs, Ibm: GOHI; SPF
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Remarks:
- bi-distilled water
- Concentration / amount:
- 0.1 ml
of a 5 % solution of test item in distilled water
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and
physiological saline
2) test substance diluted to 5% (w/w) in bidistilled water
3) test substance diluted to 5% (w/w) by emulsion in a 1:1
(v/v) mixture of Freund's Complete Adjuvant and
physiological saline
epidermal:
test substance 15% in bidistilled water
Concentration of test material and vehicle used for each challenge:
epidermal:
test substance 15% in bidistilled water - Day(s)/duration:
- From day 0 to 7
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- bi-distilled water
- Concentration / amount:
- 0.3 g of a 15 % solution of test item in bi-distilled water, left for 24 hours
- Day(s)/duration:
- From day 7 to 22
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- bi-distilled water
- Concentration / amount:
- 0.1 ml
of a 15 % solution of test item in bi-distilled water
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and
physiological saline
2) test substance diluted to 5% (w/w) in bidistilled water
3) test substance diluted to 5% (w/w) by emulsion in a 1:1
(v/v) mixture of Freund's Complete Adjuvant and
physiological saline
epidermal:
test substance 15% in bidistilled water
Concentration of test material and vehicle used for each challenge:
epidermal:
test substance 15% in bidistilled water - Day(s)/duration:
- 24 hours
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Positive control substance(s):
- yes
- Remarks:
- 2-MERCAPTOBENZOTHIAZOLE
Results and discussion
- Positive control results:
- No toxic symptoms were evident in the guinea pigs of the control or test group.
No deaths occurred.
All 10 test animals showed discrete/patchy to intense erythema and swelling at the 24- and 48-hour reading after the challenge treatment with 2-MERCAPTOBENZOTHIAZOLE at 0.5 % (w/w) in mineral oil.
No skin effect was observed in the control group.
Based on the above mentioned findings in an adjuvant sensitization test (M&K-test) in guinea pigs and in accordance to Commission Directive 96/54/EEC, 2-MERCAPTOBENZOïHIAZOLE does have to be classified and labelled as a skin sensitizer.
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
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 15 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 15 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 15 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.5 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.5 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 15 %
Signs of irritation during induction:
Possible erythema reaction could not be determined due to
substance-related red-brown staining of the skin. However,
no oedema was observed.
Evidence of sensitisation of each challenge concentration:
15%: 0/10 animals showed sensitization.
Other observations: None.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Not skin sensitising
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