Registration Dossier
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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

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no positive control reported in the study report
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was performed before the implementation of the REACH regulation
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation:
- Weight at study initiation: 300 to 500 g
- Housing: groups of 5 in polystyrene cages
- Diet (ad libitum): guinea pig complete pelleted maintenance food (Pietrement, France)
- Water (ad libitum): softened and filetred drinking water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 1%
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 ml
- Day(s)/duration:
- Day 9
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 ml
- Day(s)/duration:
- Days 22
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Treated groups: 10/sex
Control groups: 5/sex - Details on study design:
- The applications corresponding to "the induction" were carried out
- By intradermal route: injection of 2 x 0.1 ml
* on one hand, with the test article in a 1 % (W/V) solution in water for, injection ;
* on the other hand, with the 50/50 (V/V) mixing : test article in a 2 % solution (W/V) in water for injection +complete Freund's adjuvant at 50 % (V/V) in isotonic injectable solution, i.e. a final 1 % concentration of thes ample to control. Injection of the test article in a 1 % solution has provoked a weak to moderate irritation.
- By topical occlusive route for 48 hours, with the test article as supplied and at the dose level of 0.5 ml per animal. This application having not provoked any weak to moderate irritation, a skin painting was carried out on Day 8, with 0.5 ml of Sodium Lauryl Sulfate at 10 % in Codex liquid paraffin.
- During the "challenge exposure", the topical occlusive application for 24 hours was carried out with the test article as supplied and at the dose level of 0.5 ml per guinea-pig (Maximum Non-Irritant Concentration : M.N.I.C.). - Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data reported
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 ml undiluted
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- 2 with an erythema score of 2 and 3 with a score of 1
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 ml undiluted
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- 1 erythema score of 3, 6 scores of 2 and 11 scores of 1
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 ml undiluted
- No. with + reactions:
- 3
- Total no. in group:
- 9
- Clinical observations:
- erythema score of 3
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 ml undiluted
- No. with + reactions:
- 10
- Total no. in group:
- 13
- Clinical observations:
- 1 erythrema score of 2 and 9 scores of 1
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
The histological examinations of the skin of 2 control and 8 treated animals presenting an erythema score of 2 or more, didn't show any specific skin reactions in 2 controls and 4 treated animals and a specific reaction of irritation of weak intensity in 4 treated guinea-pigs. This phenomenon can hide possible weak reactions of cutaneous sensitization.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Classification: not sensitizing
- Executive summary:
In an OECD TG 406, guinea pigs (n=30; sex/strain not specified) were tested for skin sensitization to di-t-dodecyl polysulfide using the guinea pig maximization test. The study was conducted according to OECD TG 406. Induction was accomplished by intracutaneous exposure to 1% of di-t-dodecyl polysulfide followed by an epicutaneous occlusive application of undiluted di-t-dodecyl polysulfide. During the challenge exposure at 24 hours, a 0.5 ml topical occlusive application of di-t-dodecyl polysulfide was carried out with the test article as supplied. From the macroscopic and histological results, it was concluded that di-t-dodecyl polysulfide was a weak irritant in four of 20 treated guinea pigs, which could mask possible weak reactions of cutaneous sensitization. No characteristic cutaneous abnormalities were noted in the 10 control guinea pigs.
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