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EC number: 277-242-0 | CAS number: 73037-34-0
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study and GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-9 weeks
- Housing: in groups of 5
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- other: aceton:olive oil = 4:1
- Concentration:
- 6.25 %, 12.5 %, 25 %
- No. of animals per dose:
- 5
- Details on study design:
- Topical application:
Each mouse was treated by topical application of the selected solution to the endire dorsal surface of each ear, once daily on 3 consecutive days.
Administration of 3H-Methyl-thymidine:
5 days after the first topical application all mice were dosed with 3H-Methyl-thymidine diluted to a working concentraion of 80 µCi/ml, by intravenous injection.
Preparation of cell suspension:
Approcimately 5 hours after the injection all mice were sacificed. The draining "auricular lymph nodes" were excised, and individually pooled for each animal (2 lymph nodes/animal) and collected in phosphate buffered saline . A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through a polyamide gauze and washed repeatedly.
Determination of Incorporated 3H-Methyl-thymidine:
The 3H-Methyl-thymidine incorporation was measured in a ß-counter for each animal. - Positive control substance(s):
- other: p-phenylene diamine (CAS No. 106-50-3)
- Statistics:
- The proliferative response of lymph node cells was expressed as the number of radioactive disintergations per minute per lymph node (DPM/NODE) and as the rate of 3H-methyl thymidine incorporation into lymph cells of test group animals relative to that recorded of control group animals (STIMULATION INDEX). Before DPM/NODE values were determined, background values were subtracted.
EC3 values, calculated concentrations which induce stimulation indices of 3 are determined by linear interpolation between two points of stimulation index axis. One above and one below the stimulation index of 3. If all measured points are above or below the stimulation index of 3 no EC3 value can be stated.
A substance is regarded as a sensitiser in the LLNA if at least one concentration of the test item results in a 3-fold or greater increase in 3H-methyl thymidine incorporation into lymph node cells of the test group relative to that recorded for the lymph nodes of control group animals (Stimulation Index equal or greater than 3.0). - Positive control results:
- Mean Stimulation index of p-phenylene diamine in this assay is 9.0
- Parameter:
- SI
- Remarks on result:
- other: None of the 3 concentrations of the test item reached the stimulation index of 3. 6.25% : 1.1 12.5 % : 1.3 25 % : 1.0
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 6.25 % : 885.1 DPM 12.5 % : 1007.3 DPM 25 %: : 817.8 DPM
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
In a Local Lymph Node Assay according to OECD TG 429 and GLP ditolylether disufonic acid disodium salt, isomer mixture dissolved in acetone/olive oil (4:1) was tested for skin sensitizing effects at concentrations of 6.25%, 12.5% and 25%. The EC3 value (derived by linear interpolation) could not be calculated as the stimulation indices of all concentrations were below 3 (6.25%: 1.1, 12.5%: 1.3, 25%: 1.0).
Consequently, according to OECD TG 429 ditolylether disufonic acid disodium salt, isomer mixture is expected to have no sensitizing properties and therefore should not be regarded as a dermal sensitizer.
Reference
All animals survived througout the test period without showing any clinical signs.
All animals showed the expected body weight development.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitization
In a Local Lymph Node Assay according to OECD TG 429 and GLP ditolylether disufonic acid disodium salt, isomer mixture dissolved in acetone/olive oil (4:1) was tested for skin sensitizing effects at concentrations of 6.25%, 12.5% and 25%. The EC3 value (derived by linear interpolation) could not be calculated as the stimulation indices of all concentrations were below 3 (6.25%: 1.1, 12.5%: 1.3, 25%: 1.0).
Consequently, according to OECD TG 429 ditolylether disufonic acid disodium salt, isomer mixture is expected to have no sensitizing properties and therefore should not be regarded as a dermal sensitizer.
Migrated from Short description of key information:
Ditolylether disufonic acid disodium salt, isomer mixture is expected to have no sensitizing properties and therefore should not be regarded as a dermal sensitizer.
Justification for selection of skin sensitisation endpoint:
The only available study is performed according to OECDGuideline and GLP and is evaluated with Klimisch Score 1.
Justification for classification or non-classification
Based on the available data no classification / labelling is required.
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