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EC number: 700-761-5 | 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2012-06-12 to 2012-06-22
- 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 404, 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.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- tetrakis{9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethylxanthylium} C12-(branched and/or linear)-alkyl-(4-sulfonatophenoxy)benzenesulfonate and oxybis[C12-(branched and/or linear)-alkyl-benzenesulfonate]
- EC Number:
- 700-761-5
- Molecular formula:
- not applicable
- IUPAC Name:
- tetrakis{9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethylxanthylium} C12-(branched and/or linear)-alkyl-(4-sulfonatophenoxy)benzenesulfonate and oxybis[C12-(branched and/or linear)-alkyl-benzenesulfonate]
- Details on test material:
- - Name of test material (as cited in study report): Sepisol Fast Red SN
- Substance type: Organic Salt - UVCB
- Physical state: Red Powder
- Analytical purity: > 99%
- Lot/batch No.: 029244
- Expiration date of the lot/batch: 2020-10-19
- Stability under test conditions: Stable
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome (quartier Labaste - F40260 Linxe)
- Age at study initiation: 11 weeks old
- Weight at study initiation: between 2.20 kg and 2.46 kg
- Housing: Individually housed
- Diet (e.g. ad libitum): Ad libitum - Tap-water from public distribution
- Water (e.g. ad libitum): Ad libitum - Foodstuff (SDS-C15)
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +/- 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: distilled water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g of the test item as supplied, moistened beforehand with distilled water
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- Exposure of 4 hours
- Observation period:
- Observation at 1, 24, 48 and 72 hrs after removal of the patch
- Number of animals:
- 1 rabbit + 2 other rabbits.
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² per patch. an untreated area on the opposite flank served as control.
- Type of wrap if used: a strip of surfical adhesive tape under semi-occlusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with distilled water and liquid paraffin
- Time after start of exposure: at the end of the exposure period, i.e after 4h.
SCORING SYSTEM: Grading of Skin Reactions as displayed in the OECD No. 404, dated April 24th, 2002.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Other effects:
- A pink coloration, not preventing local observations, was noted between days 0 and 3 in all animals.
Any other information on results incl. tables
Individual skin reactions and average scores after 4 -hour exposure
OBSERVATIONS |
INDIVIDUAL DATA |
Total of individual data |
||||||
Skin reaction |
Observation time |
Animal n° |
Weight (kg) |
Animal n° |
Weight (kg) |
Animal n° |
Weight (kg) |
|
A2132 (application date : 2012-06-12) |
Start: 2.33 |
A2174 (application date : 2012-06-19) |
Start: 2.34 |
A2177 (application date : 2012-06-19) |
Start: 2.20 |
|||
End: 2.46 |
End: 2.42 |
End: 2.32 |
||||||
|
1 hour (D0) |
0 |
0 |
0 |
0 |
|||
24 hours |
0 |
0 |
0 |
0 |
||||
48 hours |
0 |
0 |
0 |
0 |
||||
72 hours* |
0 |
0 |
0 |
0 |
||||
Mean(24 to 72 hrs) |
0.0 |
0.0 |
0.0 |
/ |
||||
Oedema formation |
1 hour (D0) |
0 |
0 |
0 |
0 |
|||
24 hours |
0 |
0 |
0 |
0 |
||||
48 hours |
0 |
0 |
0 |
0 |
||||
72 hours* |
0 |
0 |
0 |
0 |
||||
Mean(24 to 72 hrs) |
0.0 |
0.0 |
0.0 |
/ |
||||
Other reactions |
1 hour (D0) |
0² |
0² |
0² |
0 |
|||
24 hours |
0² |
0² |
0² |
0 |
||||
48 hours |
0² |
0² |
0² |
0 |
||||
72 hours* |
0² |
0² |
0² |
0 |
||||
Mean(24 to 72 hrs) |
0.0 |
0.0 |
0.0 |
/ |
* As no persistent reaction was observed 72 hours after the treatment, the study was ended.
²: pink coloration, not preventing local observations.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results obtained, in these experimental conditions, enable to conclude that the test item SEPISOL FAST RED SN must not be classified, according to the criteria for classification, packging and labelling of dangerous substances and preparations in compliance with the E.E.C. directives 67/548, 2001/59 and 99/45. No symbol or risk phrase is required.
In accordance with the regulation (EC) No. 1272/2008, the test item must not be classified. No signal word or hazard statement is required. - Executive summary:
The test item SEPISOL FAST RED SN was applied, as supplied, at the dose of 0.5 g, under semi-occlusive dressing during 4 hours on an undamaged skin area of three New Zealand rabbits. The experimental protocol was established from the OECD guideline No. 404 dated April 24th, 2002 and the test method B.4 of the Council regulation No. 440/2008 of 30 May 2008.
No cutaneaous reactions (erythema and oedema) were observed whatever the examination time (1, 24, 48 and 72 hours). A pink coloration, not preventing erythema assessment, was noted between days 0 and 3 in all animals.
The results obtained, in these experimental conditions, enable to conclude that the test item SEPISOL FAST RED SN must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. directives 67/548, 2001/59 and 99/45. No symbol or risk phrase is required.
In accordance with the Regulation (EC) No. 1272/2008, the test item must not be classified. No signal word or hazard statement is required.
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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