Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 270-335-7 | CAS number: 68425-15-0
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Based on a weight of evidence, the oral LD50 of polysulfides, di-tert-dodecyl is estimated to be higher than 2500 mg/kg bw. The dermal LD0 value for polysulfides, di-tert-dodecyl was > 2000 mg/kg bw (the highest dose tested).
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:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Reason / purpose for cross-reference:
- reference to other assay used for intermediate effect derivation
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- 7-day range finding study.
- GLP compliance:
- no
- Test type:
- other: 7-day range finding study
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Doses:
- 50, 250, 1250, 2500 mg/kg
- No. of animals per sex per dose:
- 4
- Control animals:
- no
- Details on study design:
- Clinical signs and mortality were checked twice daily. Food comsumption and body weight were record ed twice a week.Sacrifice and pathology
A complete macroscopic examination was performed on all animals killed at the end of the study. Adrenals, heart, kidneys, liver, spleen, thymus and gonades were weighed on all animals. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured during the treatment period
- Clinical signs:
- other: Ptyalism was observed in all the males given 1250 or 2500 mg/kg/day and in 2/4 or 3/4 females given 1250 or 2500 mg/kg/day, respectively
- Gross pathology:
- Thickened and/or translucent wall of forestomach was noted for 3/4 females given 2500 mg/kg/day.
No effect of treatment was observed on organ weights. - Interpretation of results:
- GHS criteria not met
- Executive summary:
In a non-guideline dose range-finding toxicity study, male and female Sprague-Dawley rats (4/sex/dose were administered 0, 50, 250, 1250, or 2500 mg/kg bw/day of di-t-dodecyl polysulfides by daily gavage for seven days. No mortality occurred during the treatment period. Ptyalism was observed in all males administered 1250 or 2500 mg/kg bw/day, and in 2/4 and 3/4 females administered 1250 and 2500 mg/kg bw/day, respectively. A slightly lower mean food consumption and body weight gain was observed in the males administered 2500 mg/kg/day. A thickened and/or translucent wall of the forestomach was noted for 3/4 females at 2500 mg/kg bw/day. There was no effect of treatment on organ weights.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- In the range finding part of the micronucleus assay, 5 male and 5 female rats were treated twice by oral gavage with a dose level of 2000 mg/kg and observed for 24 hours after the last treatment.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River France origin, Saint-Germain-surl’Arbresle; FRANCE
- Age at study initiation: 5 to 10 weeks old
- Weight at study initiation: approximately 200 g
- Assigned to test groups randomly: yes
- Fasting period before study: no
- Housing: animals were housed in polypropylene cages measuring 42.5 x 26.6 x 15 cm, covered by a stainless steel netted lid, in which they will be placed in groups of 3 or 2
- Diet (ad libitum): 801175 RM1(P)DU IRR 9Kgy irradiated from Special Diets Services
(ENGLAND).
- Water (ad libitum): softened by reverse osmosis and filtered on 0.2 µm membrane
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 20 times per hour - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 24h after the 2nd treatment
- Necropsy of survivors performed: no - Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality and clinical signs over 24 h
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No clinical sign was observed
- Gross pathology:
- Not performed
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In the range finding part of a micronucleus assay, 5 male and 5 female Sprague-Dawley rats were treated twice by oral gavage with a dose level of 2000 mg/kg of di-t-dodecyl polysulfides (TPS 32) and observed for 24 hours after the last treatment. No mortality and clinical signs were observed.
- Endpoint:
- acute toxicity: oral
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Qualifier:
- according to guideline
- Guideline:
- other: REACH guidance. Chapter R.6: QSARs and grouping of chemicals
- Version / remarks:
- May 2008
- Principles of method if other than guideline:
- T.E.S.T allows you to estimate the value for oral rat LD50 (amount of chemical in mg/kg body weight that causes 50% of rats to die after oral ingestion)
- Specific details on test material used for the study:
- Canonical SMILES: CC(C(C)(C)C)C(C)(C)C(C)(C)SSSC(C)(C)C(C)(C)C(C)C(C)(C)C
- Species:
- rat
- Route of administration:
- oral: unspecified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 20 008 mg/kg bw
- Interpretation of results:
- GHS criteria not met
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Pre-guideline study, poorly documented
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Groups of 5-10 male mice were treated by oral gavage with a dose level of 12.5, 25, 30, 40 and 50 ml/kg. The mortality was observed on a 7-day period. Clinical signs and body weight gain were not reported.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Saint Denis de Pile (33), France
- Age at study initiation: no data
- Weight at study initiation: 22 +/-2 g
- Fasting period before study: 16 h
- Housing: 5/cage
- Diet (ad libitum): UAR, France
- Water (ad libitum): tap water
- Acclimation period:no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-1
- Humidity (%): 55
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data - Route of administration:
- oral: gavage
- Vehicle:
- other: undiluted
- Doses:
- 12.5, 25, 30, 40 and 50 ml/kg
- No. of animals per sex per dose:
- 5 or 10
- Details on study design:
- The mortality was observed on a 7-day period. Clinical signs and body weight gain were not reported.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 45 mL/kg bw
- Based on:
- test mat.
- Mortality:
- Dose (ml/kg) Mortality
12.5 0/5
25 2/5
30 3/10
40 4/10
50 10/10 - Clinical signs:
- other: No data
- Gross pathology:
- No data
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In a pre-guideline study, male Swiss mice (n=40) were dosed with di-t-dodecyl polysulfide. Mortality was observed over a 7-day period; clinical signs and body weight gain were not reported. The LD50 was ca. 45.0 ml/kg bw.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 500 mg/kg bw
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:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA-CREDO, France
- Age at study initiation: 5-7 weeks old
- Mean weight at study initiation: 189-192g for males and 164-166g for females
- Housing: individual housing in stainless steel mesh cages
- Diet (ad libitum): Rat pelleted complete maintenance (UAR, France)
- Water (ad libitum): softened and filtered drinking water
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: 10%
- Type of wrap if used: wide aghesive and perforated tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with lukewarm water
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml/kg - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- other: yes, distillated water
- Details on study design:
- - Duration of observation period following administration: 14 days
- Clinical signs ans skin reactions: 15 min after administration, then 1, 2 and 4 hours and daily for 14 days
- Body weight: day -1, 1, 8 and 15
- Necropsy of survivors performed: yes - Statistics:
- Not appropriate
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: No mortality and no behavioral anomalies were noted following the administration of the product and during the 14 following days. The local tolerance of the product was good: no cutaneous lesions (erythema or oedema) were observed at the site of product a
- Gross pathology:
- No macroscopic abnormality was observed in the animals sacrificed at the end of the observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD0 of TPS 32 is higher than 2000 mg/kg.
- Executive summary:
In an OECD TG 402 study, Sprague-Dawley rats (n=20; male and female) were dermally exposed to di-t-dodecyl polysulfides (TPS 32). No mortality or behavioral abnormalities were noted following the initial administration of the test substance or during the 14 days following exposure. No cutaneous lesions were observed at the site of application or during the observation period. Body weight gain was not affected by the treatment, and no macroscopic abnormalities were observed in the animals sacrificed at the end of the observation period. The dermal LD0was > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
Oral route
In a non-guideline dose range-finding toxicity study, male and female Sprague-Dawley rats (4/sex/dose were administered 0, 50, 250, 1250, or 2500 mg/kg bw/day of di-t-dodecyl polysulfides by daily gavage for seven days (Molinier, 1995). No mortality occurred during the treatment period. Ptyalism was observed in all males administered 1250 or 2500 mg/kg bw/day, and in 2/4 and 3/4 females administered 1250 and 2500 mg/kg bw/day, respectively. A slightly lower mean food consumption and body weight gain was observed in the males administered 2500 mg/kg/day. A thickened and/or translucent wall of the forestomach was noted for 3/4 females at 2500 mg/kg bw/day. There was no effect of treatment on organ weights.
In the range finding part of a micronucleus assay (Simar, 2010), 5 male and 5 female Sprague-Dawley rats were treated twice by oral gavage with a dose level of 2000 mg/kg of polysulfides, di-tert-dodecyl and observed for 24 hours after the last treatment. No mortality and clinical signs were observed.
An oral LD50 in rats of 20008 mg/kg was estimated using the Toxicity Estimation Software Tool (T.E.S.T) of the US EPA (2017).
In a pre-guideline study (Lauressergues, 1973), male Swiss mice (n=40) were dosed with polysulfides, di-tert-dodecyl. Mortality was observed over a 7-day period; clinical signs and body weight gain were not reported. The LD50 was ca. 45.0 ml/kg bw.
Dermal route
In an OECD TG 402 study, Sprague-Dawley rats (n=20; male and female) were dermally exposed to polysulfides, di-tert-dodecyl (Guillot, 1986a). No mortality or behavioral abnormalities were noted following the initial administration of the test substance or during the 14 days following exposure. No cutaneous lesions were observed at the site of application or during the observation period. Body weight gain was not affected by the treatment, and no macroscopic abnormalities were observed in the animals sacrificed at the end of the observation period. The dermal LD0 was > 2000 mg/kg bw.
Justification for classification or non-classification
According to the available data and criteria of regulation no. 1272/2008, no classification is warranted for oral, dermal and inhalation acute toxicity.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)