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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
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: In this guideline study according to OECD TG 407 and GLP reproductive organs of male and female rats were examined for adverse effects.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 407
- GLP compliance:
- yes
- Type of method:
- in vivo
Test material
- Reference substance name:
- Disodium oxybis[methylbenzenesulphonate]
- EC Number:
- 277-242-0
- EC Name:
- Disodium oxybis[methylbenzenesulphonate]
- Cas Number:
- 73037-34-0
- Molecular formula:
- C14H12Na2O7S2
- IUPAC Name:
- disodium oxybis(methylbenzenesulfonate)
- Test material form:
- solid
- Details on test material:
- Active content reported: 90-95 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: males 153-173 g, females 133-151 g
- Housing: individually
- 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
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- All animals were treated with the test item or vehicle for 7 days per week for a period of 28 days.
The test item formulation or vehicle was administered at a single dose to the animals by oral gavage.
For each animal the individual dosing volume was calculated on the basis of the body weight most recently measured.
The application volume for all groups was 5 ml/kg bw . - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Determination of the nominal concentration in dosing formulations including stability and and homogenicity.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily, 7 days per week
- Duration of test:
- 28 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The test item was administered 7 days per week in graduated doses to 3 groups of male and 3 groups of female rats.
Animals of an additional control group were handeled identically.
All animals were observed daily for clinical signs.
Body weight and food conclumption was measured twice weekly.
Determination of hematology values and clinical chemistry values was done at termination of the treatment.
Sacrifice of surviving animals and organ weight determination.
Gross pathological examination and histopathological examination when adverse effects were observed. - Statistics:
- A statistical assessment of the results of the body weight, food consumption, parameters of haematology, blood coagulation and clinical biochemistry and absolute and relative organ weights was performed for each gender by comparing values of dosed with control animals using a one-way ANOVA and a post-hoc Dunnett Test. Statistical analysis of paired organs was performed on total weight of the particular paired organ. These statistics were performed with GraphPad Prism V.5.01 software (p<0.05 is considered as statistically significant).
Results and discussion
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: no effects on reproductive organs were detected
Observed effects
With respect of reproductive organs in male and female rats no adverse effects were observed in none of the treated animals.
Applicant's summary and conclusion
- Executive summary:
In a subacute toxicity study according to OECD TG 407 ditolylether disulfonic acid disodium salt, isomer mixture dissolved in water was administered 7 days per week in graduated doses (100, 300, 1000 mg/kg bw/day) to 3 groups of male and 3 groups of female rats. Animals of an additional control group were handled identically (see also section 7.5.1 Repeated dose toxicity).
Based on the data referring to reproductive organs in treated male and female rats generated from this study, no significant toxicological effects of ditolylether disulfonic acid disodium salt, isomer mixture were found up to 1000 mg/kg bw/day. Therefore the NOEL (No Observed Effect Level) is considered to be 1000 mg/kg bw/day.
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