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EC number: 420-680-6 | CAS number: 134127-48-3
- 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:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- other: "Allergic Contact Dermatitis in the Guinea-Pig: Identification of Contact Allergens" Magnusson B. Kligman A.M., 1970 published by C.C. Thomas, Springfield, Illinois, USA
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- data were already available
Test material
- Reference substance name:
- -
- EC Number:
- 420-680-6
- EC Name:
- -
- Cas Number:
- 134127-48-3
- Molecular formula:
- C47 H47 Cl N2 O3 S
- IUPAC Name:
- 2-{2-[2-chloro-3-(2-{1,3,3-trimethyl-1H,2H,3H-benzo[g]indol-2-ylidene}ethylidene)cyclohex-1-en-1-yl]ethenyl}-1,1,3-trimethyl-1H-benzo[e]indol-3-ium 4-methylbenzene-1-sulfonate
- Details on test material:
- The identity of the test material concerns the same ECnumber as the substance in section 1. The purity of the test material is not described in the report, and thus might differ from the purity of the substance in section 1.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- intradermal injection with a 1% concentration and epidermal occlusive exposure (both in induction and challenge phase) to a 50% concentration
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- intradermal injection with a 1% concentration and epidermal occlusive exposure (both in induction and challenge phase) to a 50% concentration
- No. of animals per dose:
- 10 females in experimental group
5 females in negative control group - Details on study design:
- Challenge assessment: 24 and 48 hours after removal of the dressing
- Challenge controls:
- 5 females
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamic aldehyde, tech. 85%
Results and discussion
- Positive control results:
- sensitisation rate of 80% to a 10% concentration of the positive control substance
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Green/brown staining was observed at all test substance treated skin sites, 24 and 48 hours after challenge. This staining did not hamper the scoring of the skin reactions.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 50% . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Green/brown staining was observed at all test substance treated skin sites, 24 and 48 hours after challenge. This staining did not hamper the scoring of the skin reactions..
- Reading:
- other: challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- see challenge results at 24 hours after challenge.
- Remarks on result:
- other: Reading: other: challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 50% . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: see challenge results at 24 hours after challenge..
- Reading:
- other: challenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: other: challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- other: challenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: other: challenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% . No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- other: challenge
- Hours after challenge:
- 48
- Group:
- other: testgroup + negative control
- Dose level:
- water
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Remarks on result:
- other: Reading: other: challenge. . Hours after challenge: 48.0. Group: other: testgroup + negative control. Dose level: water. No with. + reactions: 0.0. Total no. in groups: 15.0.
Any other information on results incl. tables
Toxicity/mortality: no mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study
Body weights: body weights and body weight gain of experimental animals reamined in the same range as controls over the study period
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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