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EC number: 248-324-3 | CAS number: 27206-35-5
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-05-26 - 2015-08-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well-documented GLP OECD guideline study without relevant deviations on the registered substance itself
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- The relative air humidity exceeded 70% a few times. These changes were temporary and did not influence the study course and results.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- yes
- Remarks:
- The relative air humidity exceeded 70% a few times. These changes were temporary and did not influence the study course and results.
- Qualifier:
- according to guideline
- Guideline:
- other: Standard Operating Procedure SOP/T/21: „Acute dermal toxicity study”
- Deviations:
- yes
- Remarks:
- The relative air humidity exceeded 70% a few times. These changes were temporary and did not influence the study course and results.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium 3,3'-dithiobis[propanesulphonate]
- EC Number:
- 248-324-3
- EC Name:
- Disodium 3,3'-dithiobis[propanesulphonate]
- Cas Number:
- 27206-35-5
- Molecular formula:
- C6H14O6S4.2Na
- IUPAC Name:
- disodium 3,3'-disulfanediyldipropane-1-sulfonate
- Reference substance name:
- 1- Propanesulfonic acid, 3,3'-dithiobis-, disodium salt
- IUPAC Name:
- 1- Propanesulfonic acid, 3,3'-dithiobis-, disodium salt
- Reference substance name:
- disodium 3,3'- dithiobis[propanesulphonate]
- IUPAC Name:
- disodium 3,3'- dithiobis[propanesulphonate]
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): SPS
- Substance type: pure substance
- Storage condition of test material: room temperature (20 ± 5°C)
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Wistar male and female rats (Cmdb: WI; outbred) coming from the husbandry of laboratory animals of the Experimental Medicine Centre at the Medical University in Białystok
- Age at study initiation: 8 weeks (males), 11 weeks (females)
- Weight at study initiation: average 267.8g (males) resp. 217.6g (females)
- Fasting period before study: no
- Housing: After the application of the test item, each animal was housed individually. After the removal of the test item from the animals’ skin, there were five rats in one cage. Each sex was kept separately.
- Diet (e.g. ad libitum): “Murigran” standard granulated fodder (batch number: 3/15, 4/15, 5/15) produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24 °C
- Humidity (%): 35 – 75%
- Air changes (per hr): about 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10% of the body surface area
- Type of wrap if used: gauze patch, PCV foil, elastic bandage and a sticking plaster
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg b.w.
- Concentration (if solution): substance was moistened with a few drops of wwater
- For solids, paste formed: yes - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg b.w.
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: general conditions twice a day or once a day (on days off), clinical observations once a day, body weight on day 0, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: clinical observations, detailed gross examination which comprised the observation of the external body surface, all natural apertures, and the cranial, thoracic, and abdominal cavities with thei r contents
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: All animals survived the 14 day observation period.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: All animals survived the 14 day observation period.
- Mortality:
- All animals survived the experiment.
- Clinical signs:
- other: Following single application of the test item, the animals did not exhibit any general clinical signs. No pathological changes on the treated skin were noticed.
- Gross pathology:
- The gross examination did not reveal any pathological changes in the examined animals.
Any other information on results incl. tables
Table 1 -Clinical signs-overall list
Dose (mg/kgb.w.) |
Sex |
Day after application |
Number of living animals |
Rat number |
||||
1 |
2 |
3 |
4 |
5 |
||||
|
|
0 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
1 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
2 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
3 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
4 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
5 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
6 |
5 |
NC |
NC |
NC |
NC |
NC |
|
males |
7 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
8 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
9 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
10 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
11 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
12 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
13 |
5 |
NC |
NC |
NC |
NC |
NC |
2000 |
|
14 |
5 |
NC |
NC |
NC |
NC |
NC |
|
0 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
|
1 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
2 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
3 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
4 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
5 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
6 |
5 |
NC |
NC |
NC |
NC |
NC |
|
females |
7 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
8 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
9 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
10 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
11 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
12 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
13 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
14 |
5 |
NC |
NC |
NC |
NC |
NC |
NC =no changes
Table 2 - Body weights of the animals (g) - overall list.
Dose (mg/kgb.w.) |
Sex |
Rat number |
Day of experiment / Body weight(g) |
Body weight gain(g) (0-14) |
||
0 |
7 |
14 |
||||
|
|
1 |
284 |
293 |
330 |
46 |
|
|
2 |
247 |
269 |
282 |
35 |
|
males |
3 |
254 |
267 |
284 |
30 |
|
|
|||||
|
|
4 |
270 |
271 |
292 |
22 |
2000 |
|
5 |
284 |
310 |
339 |
55 |
|
|
1 |
216 |
225 |
243 |
27 |
|
|
2 |
208 |
220 |
230 |
22 |
|
females |
3 |
211 |
221 |
232 |
21 |
|
||||||
|
|
4 |
225 |
226 |
242 |
17 |
|
|
5 |
228 |
227 |
233 |
5 |
Applicant's summary and conclusion
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- The study was conducted under GLP according to OECD guideline 402 on the registered substance itself. The method is to be considered scientifically reasonable with no deficiencies in documentation. Hence, the results can be considered as reliable to assess the acute oral toxicity in rats.
Following single application of SPS at a dose of 2000 mg/kg bw, the animals did not show any general clinical signs. No pathological changes on the treated skin of males and females were found. All animals survived the experiment. During the 14-day experiment, body weight gain was found in all animals. Gross examination did not reveal any pathological changes in the examined animals. So it may be stated that the median lethal dose (LD50) of SPS is greater than 2000 mg/kg b.w. Since no animal showed at no observation time any pathological changes on the treated skin or other signs of irritation, it may be concluded that, under the conditions of this test, SPS does not need to be considered as irritating to rat skin.
According to the Regulation (EC) No. 1272/2008, it may be concluded that SPS is beyond categorization. - Executive summary:
In an acute dermal toxicity study (OECD 402), groups of 8-11 weeks old Wistar (Crl: WI(Han); outbred) rats (5/sex) were dermally exposed to moistened disodium 3,3'-dithiobis[propanesulphonate])(SPS) for 24 hours on 10% of body surface area at a dose of 2000 mg/kg bw under occlusive coverage. Animals then were observed for 14 days.
Following single application of the test item, the animals did not show any general clinical signs. No pathological changes on the treated skin of males and females were found. All animals survived the experiment. During the 14-day experiment, body weight gain was found in all animals. Gross examination did not reveal any pathological changes in the examined animals. Hence, the following results could be gained:
LD0(dermal) ≥ 2000 mg/kg bw
LD50(dermal) > 2000 mg/kg bw
SPS is of low Toxicity based on the LD50 determined. Since no animal showed at no observation time any pathological changes on the treated skin or other signs of irritation, it may be concluded that, under the conditions of this test, SPS does not need to be considered as irritating to rat skin.
According to Regulation (EC) No. 1272/2008, it may be concluded that SPS is beyond categorization.
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