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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
The acute toxicity of ditolylether disulfonic acid disodium salt, isomer mixture was tested using the oral and the dermal route yielding an LD50 >2000 mg/kg bw for both application routes. In none of the studies amanimals died or displayed signs of intoxication. Thus, the conditions according to Regulation (EC) 1907/2006 (REACH) ANNEX VIII, section 8.5 column 2 are fulfilled.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Weight at study initiation: step 1/animals no.1-3: 177-181 g, step 2/animals no 4-6: 178-183 g
- Fasting period before study: 16-19 hours
- Housing: in groups
- 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 - Route of administration:
- oral: gavage
- Vehicle:
- other: sterile water
- Details on oral exposure:
- The test item was administered at a single dose by gavage using a feeding tube.
The test item was administered at a dose volume of 10 mg/ kg bw.
All animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality. - Doses:
- The starting dose was selected to be 2000 mg/kg bw. ( step 1 and step 2).
As no animal died no further testing is required. - No. of animals per sex per dose:
- 3 females in each step
- Control animals:
- no
- Details on study design:
- The test item was administered at a single dose by gavage using a feeding tube to 3 female rats in each step.
The test item was administered at a dose volume of 10 mg/ kg bw.
All animals were observed for 14 days after dosing for general climical signs, morbidity and mortality.
All animals were weighed on day 1 prior to dosing and on days 8 and 12.
A careful examination was made severla times on the day of dosing and thereafter once daily. - Statistics:
- no
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No compound - related mortality was recorded for any animal of step 1 and step 2.
- Clinical signs:
- other: female rat 1-6: No signs of toxicity were observed during the whole observation period.
- Gross pathology:
- At necropsy, some macroscopic changes (female 4 and 5: red spots on the lungs) were observed. These findings are not considered to be test item related.
No specific gross pathological changes were reported. - Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Executive summary:
Two groups, each of three female Wistar rats, are treated with ditolylether disulfonic acid disodium salt, isomer mixture by oral gavage administration at a dosage of 2000 mg/kg bw (OECD TG 423 and GLP). All animals were observed for 14 days post dosing. No mortality occurred and no clinical signs of intoxication were noted. Body weight gain was within the normal range. At necropsy, no treatment related macroscopic findings were observed in any animal of any step. Thus, the LD50 is > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study is GLP compliant and has Klimisch score 1.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- 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 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: males 9 weeks, females 14 weeks
- Weight at study initiation: males 222-246 g, females 211-224 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 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The test item was applied at a single dose, uniformly over an area which was approximately 10 % of the total body surface.
The test item was moistened with water to ensure good skin contact and was held in place by semi-occlusive dressing for 24 hours.
At the end of the exposure period (24 hours) the residual test item was removed using tap water - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- other: the opposite site to the treatment area
- Details on study design:
- The test item was applied at a single dose, uniformly over an area which was approximately 10 % of the total body surface.
The test item was moistened with water to ensure good skin contact and was held in place by semi-occlusive dressing for 24 hours.
At the end of the exposure period (24 hours) the residual test item was removed using tap water.
Animals were observed for 14 days for clinical signs and mortality. Necropsy was performed at the end of the study. - Statistics:
- no
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no rat died, no signs of acute dermal toxiciy, no significant signs of dermal irritation
- Mortality:
- no rat died
- Clinical signs:
- other: no clinical signs of systemic toxicity: no significant signs of irritation
- Gross pathology:
- No specific gross pathological changes were recorded for any animal.
- Other findings:
- No erythema or oedema was observed. Eschar was observed in 3 or 5 male and 4 of 5 female animals. These signs of irritation were reversible within the observation period in all animals with exception of one female rat.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Executive summary:
5 male and 5 female rats were dermally treated with moistened 2000 mg/kg bw ditolylether disulfonic acid disodium salt, isomer mixture for 24 hours. (OECD TG 402, limit test). The test item was held in place by semi-occlusive dressing.
Under the condition of this study single dermal application of ditolylether disulfonic acid disodium salt, isomer mixture to rats was associated with no mortality and neither signs of toxicity nor significant signs of irritation.
The dermal LD50 was determined to be > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study is GLP compliant and has Klimisch score 1.
Additional information
Acute oral toxicity
Two groups, each of three female Wistar rats, are treated with ditolylether disulfonic acid disodium salt, isomer mixture by oral gavage administration at a dosage of 2000 mg/kg bw (OECD TG 423). All animals were observed for 14 days post dosing. No mortality occurred and no clinical signs of intoxication were noted. Body weight gain was within the normal range. At necropsy, no treatment related macroscopic findings were observed in any animal of any step. Thus, the LD50 is > 2000 mg/kg bw.
Acute inhalation toxicity
In addition to the acute oral study there is another acute study available using dermal exposure route. There is no need to perform an acute inhalation toxicity study because the conditions according to Regulation (EC) 1907/2006 (REACH) ANNEX VIII, section 8.5 column 2 are fulfilled.
Acute dermal toxicity
5 male and 5 female rats were dermally treated with moistened 2000 mg/kg bw ditolylether disulfonic acid disodium salt, isomer mixture for 24 hours (OECD TG 402, limit test). The test item was held in place by semi-occlusive dressing.
Under the condition of this study single dermal application of ditolylether disulfonic acid disodium salt, isomer mixture to rats was associated with no mortality and neither signs of toxicity nor significant signs of irritation.
The dermal LD50 was determined to be > 2000 mg/kg bw.
Overall conclusion
There are two acute toxicity studies with ditolylether disulfonic acid disodium salt, isomer mixture available using different application routes. Thus, the conditions according to Regulation (EC) 1907/2006 (REACH) ANNEX VIII, section 8.5 column 2 are fulfilled. The results of these studies show that ditolyether disulfonic acid disodium salt, isomer mixture is practically non-toxic. These studies are of high quality (Klimisch score = 1) and therefore, there is no reason to believe that these results would not be applicable to humans.
Justification for selection of acute toxicity – oral endpoint
only one study available
Justification for selection of acute toxicity – inhalation endpoint
In addition to the acute oral study there is another acute study available using dermal exposure route. Thus, the conditions according to Regulation (EC) 1907/2006 (REACH) ANNEX VIII, section 8.5 column 2 are fulfilled.
Justification for selection of acute toxicity – dermal endpoint
only one study is available
Justification for classification or non-classification
Based on the available data no classification and labelling 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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