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EC number: 700-610-3 | 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 2008-03-13 to 2008-04-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The reliability is rated 1 because the study followed the standard guideline of reference (OECD 406), which describes a procedure designed to evaluate this endpoint, the results were reviewed for reliability and assessed as valid, and the study was conducted under GLP condition.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3- sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate
- IUPAC Name:
- Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3- sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate
- Reference substance name:
- Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3-sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate
- EC Number:
- 700-610-3
- Molecular formula:
- UVCB substance - not applicable
- IUPAC Name:
- Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3-sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate
- Details on test material:
- - Name of test material (as cited in study report): Sepisol Fast Blue 2BR
- Substance type:organic
- Physical state: blue powder
- Lot/batch No.: 905536
- Storage condition of test material: normal temperature and in the dark
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: S.C.E.A du Peycher (24610 Villefranche, France)
- Weight at study initiation: 358.6 to 439.0
- Housing: Singly housed, in polypropylene cage (31 cm x 46 cm x 19 cm) with a stainless steel lid. Dust-free sawdust litter.
- Diet: granules 106 (supplied by SAFE (89290 Augy, France))
- Water:ad libitum. Distributed by a polypropylene biberon with a stainless steel teat.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- Induction exposure : 60% of the test material in olive oil.
Challenge exposure: 60% and 30% of the test material in olive oil.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- Induction exposure : 60% of the test material in olive oil.
Challenge exposure: 60% and 30% of the test material in olive oil.
- No. of animals per dose:
- 2 animals for the pilot study (to determine the highest mild irritating dose and the highest non-irritating dose)
20 animals for the test group
10 animals for the control group - Details on study design:
- RANGE FINDING TESTS:
2 animals were used.
The highest dose tested was 60% in olive oil, which was determined to be the maximal non-irritating concentration for both the induction and the challenge exposure. For the challenge exposure, a second concentration, named "safety concentration" was derived by dividing the 60% in olive oil dose by 2.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 2 weeks for the test group
- Test groups: 20
- Control group: 10
- Site: scapular area
- Frequency of applications: Days 1, 8 and 15
- Duration: 6 hours +/- 10 min
- Concentrations: 60 %
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: on the 29th day
- Exposure period: 6hrs +/- 10 min for both the test and the control group.
- Site: lombar dorsal area
- Test groups: 0.50 mL of the test item at the maximum non-irritating concentration (60%) and at half maximum non-irritating concentration (30%)
- Control group: 0.50 mL of the vehicle
- Concentrations:30% and 60%
- Evaluation (hr after challenge): 1 day and 2 days after removal of challenge exposure - Challenge controls:
- 10 male animals used as control group. They were untreated during the induction phase
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
Study design: in vivo (LLNA)
- Concentration:
- -
- No. of animals per dose:
- -
- Details on study design:
- -
- Statistics:
- -
Results and discussion
- Positive control results:
- -
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- na
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: na.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- na
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: na.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 60 and 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- na
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60 and 30 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: na.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 60 and 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- na
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60 and 30%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: na.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: -
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: -
Any other information on results incl. tables
Maximal irritating concentration was determined to be 60 % in olive oil
Maximum Non-irritating Concentration was determined to be 60 % in olive oil.
(No maximum irritating concentration was determined so the maximum non-irritating concentration was used).
vehicle : olive oil
Groups |
Animals Number |
Skin reaction as a function of concentration and time reading |
|||||||
60 % |
30 % |
Vehicule |
CWA |
||||||
24 hr |
48 hr |
24 hr |
48 hr |
24 hr |
48 hr |
24 hr |
48 hr |
||
Control Group |
From 3869 up to 3878 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
% reactive animals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Treated group |
From 3879 up to 3898 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
% reactive animals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0: no visible modification
CWA: control wiping acetone
Weight of a animals were recorded for controls and tested groups. No differences was noticed
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test element at the concentration of 60 % in olive oil was not classified among the chemicals which may cause sensitization by skin contact.
- Executive summary:
The aim of the study was to assess, in 30 guinea-pigs, the skin sensitisation potential of the test element under occlusive patch. The 20 treated animals were exposed 3 times to the test element by epidermal application at the concentration of 60% with olive oil. Concurrently, the 10 control animals received olive oil by epidermal application. Following a rest period of 14 days ending the induction period, all the animals were exposed to the challenge dose of 60 % of the test item with olive oil and the security dose of 30%.
The extent, degree and duration of skin reaction to the challenge exposure in the test animals were compared with those demonstrated by control animals.
The test element at the concentration of 60 % in olive oil was not classified among the chemicals which may cause sensitization by skin contact in accordance with the regulation 1272/2008.
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