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Reaction product of acid red 143 (free acid) or the respective sodium salt (e.g Lansyn red F-5B) (UVCB) with Tetrabutylammonium bromide (CAS nr.: 1643-19-2) resulting in a mixture of AR143-(TBN)2 (Main component), AR143-(TBN), AR143-(TBN)3, AR143-(TBN) without alkyl tail, AR143-(TBN)2 without alkyl tail.Chemical name main component AR143-(TBN)2:di-(tetra-n-butylammonium) salt of 1-benzoyl-4-[4'-(1'',1''-dimethylpropyl)-phenoxy]-6-phenylamino-2,7-dioxo-2,7-dihydro-3H-naphtho(1,2,3-de)quinolin, disulfonic acid
EC number: 944-248-6 | 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25/10/2006 - 20/11/2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals, Section 4, Health Effects, No. 429, "Skin Sensitisation: Local Lymph Node Assay", Paris Cedex, April 2002.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- European Community (EC), Council Directive 67/548/EEC, Annex V, Part B, Methods for the Determination of Toxicity, as last amended by Commission Directive 2004/73/EC, B.42: "Skin Sensitisation: Local Lymph Node Assay", April 2004.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- Environmental Protection Agency (EPA): Health Effects Guidelines OPPTS 870.2600. "Skin Sensitisation", March 2003
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- -
- EC Number:
- 473-100-9
- EC Name:
- -
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Description: dark purple powder
- Solubility in the water: <= 0.412 g/L
- Melting point: > 250 °C
- Boiling point: > 250 °C
- Explosion: not explosion
- Log Pow: >= 3.3
- Test substance storage: at room temperature in the dark, 20°C, dry store
- Stability under storage conditions: stable
1
- Specific details on test material used for the study:
- pH (1% in water, indicative range) 8.1-8.3 (determined at NOTOX)
Stability at higher temperatures Maximum temperature 75°C, maximum duration 48 hours
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Species:
Mouse, CBA strain, inbred, SPF-quality. Recognized by the international guideline as the recommended test system (e.g. OECD, EC, EPA). Source: Charles River France, L'Arbresle Cedex, France
Number of animals:
20 females (nulliparous and non-pregnant), five females per group
Age and bodyweight:
Yound adult animals (approx. 11 weeks old) were selected. Body weight variation was within +- 20% of the sex mean.
Identification:
tail mark with marker pen
Health inspection:
A health inspection was performed prior to treatment, to ensure that the animals are in a good state of health. Special attention was paid to the ears, which were intact and free from any abnormality.
Reliability check:
the results of a reliability test with Hexylcinnamic aldehyde, performed not more than 6 months previously or 2 month afterwards, are summarized in the Appendix. Similar procedures were used in the reliability tests and in the study
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Remarks:
- Merck, Darmstadt, Germany
- Concentration:
- The results of the epidermal exposures for the selection of highest test substance concentration to be tested in the main studey are described in the table. Based on the results, the highest test substance concentration selected for the main study was a 10% concentration.
- No. of animals per dose:
- Three groups of five animals were treated with one test substance concentration per group. The highest test substance concentration was selected from the preliminary irritation study. One group of five animals was treated with vehicle.
Results and discussion
In vivo (LLNA)
Results
- Key result
- Parameter:
- EC3
- Value:
- ca. 13.1
- Variability:
- An EC3 value of 13.1% was calculated using the linear interpolation
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION
The SI values calculated for the substance concentrations 2.5, 5 and 10% were 1.2, 2.7 and 2.4 respectively.
EC3 CALCULATION
Since there was no indication that the test substance could elicit an SI >= 3 when tested up to 10%, it was established that the EC3 value (if any) exceeds 10%.
CLINICAL OBSERVATIONS:
BODY WEIGHTS
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. The slight body weight loss, noted in some animals, was considered not toxicologically significant.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The SI values calculated for the substance concentrations 2.5, 5 and 10% were 1.2, 2.7 and 2.4 respectively.
Since there was no indication that the test substance could elicit an SI >= 3 when tested up to 10%, it was established that the EC3 value (if any) exceeds 10%.
The six month reliability check with Hexylcinnamic aldehyde indicates that the Local Lymph Node Assay as performed at NOTOX is an appropriate model for testing for contact hypersensitivity. - Executive summary:
Based on the results:
- according to the recommendations made in the test guidelines, SXJUL2006 would not be regarded as skin sensitizer.
- according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (New York and Geneva, 2003), SXJUL2006 does not have to be classified for sensitization by skin contact
- according to the EC criteria for classification and labeling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), SXJUL2006 does not have to be classified and has no obligatory labeling requirement for sensitization by skin contact.
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