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EC number: 224-226-6 | CAS number: 4253-90-1
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Di-tert-butyl trisulphide
- EC Number:
- 224-226-6
- EC Name:
- Di-tert-butyl trisulphide
- Cas Number:
- 4253-90-1
- Molecular formula:
- C8H18S3
- IUPAC Name:
- di-tert-butyltrisulfane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Grimaud frères selection S.A.S., La Corbière, Roussay, Franc
- Age at study initiation: 2 to 4 months old
- Weight at study initiation: 2.4 ± 0.1 kg
- Housing: individually in polystyrene cages
- Diet (e.g. ad libitum): 110C pelleted diet (SAFE, Villemoisson, Epinay sur-Orge, France)
- Water (e.g. ad libitum): Filtered tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 3 minutes, 1 hour and 4 hours.
- Observation period:
- The skin was examined approximately 1 hour, 24, 48 and 72 hours after removal of the dressing.
Since there were persistent irritation reactions at 72 hours, the observation period was extended. In the absence of complete reversibility of skin reactions on day 15, the study was ended. - Number of animals:
- 3
- Details on study design:
- TPS 44 was first evaluated on a single animal (No. 382). The durations of exposure were 3 minutes, 1 hour and 4 hours.
Since the test item was not severely irritant on this first animal, it was then applied for 4 hours to two other animals (Nos. 751 and 752).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Remarks on result:
- other: 4-hour exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 4-h exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13 days
- Remarks on result:
- other: 4-hour exposure
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 4-h exposure
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 4-h exposure
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: 4-h exposure
- Irritant / corrosive response data:
- After a 3-minute exposure (one animal)
A very slight or well-defined erythema (grade 1 or 2) was noted from day 1 up to the end of the observation period (day 15).
A very slight or slight edema (grade 1 or 2) was observed from day 3 up to day 9.
Dryness of the skin was also recorded from day 5 up to the end of the observation period (day 15).
After a 1-hour exposure (one animal)
A very slight or well-defined erythema (grade 1 or 2) was noted from day 1 up to the end of the observation period (day 15).
A very slight or slight edema (grade 1 or 2) was observed from day 4 up to day 9.
Dryness of the skin was also recorded from day 6 up to the end of the observation period (day 15).
After a 4-hour exposure (three animals)
A very slight or well-defined erythema (grade 1 or 2) was noted in all animals from day 1 up to day 12, 13 or 15 (end of the observation period).
A very slight or slight edema (grade 1 or 2) was observed in 2/3 animals from day 1 up to day 3 or 7.
Dryness of the skin was also recorded in all animals between days 5 and 15 (end of the observation period).
Mean scores over 24, 48 and 72 hours for each animal were 2.0, 2.0 and 2.0 for erythema and 0.0, 1.0 and 2.0 for edema.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- TPS 44 was a mild irritant when applied topically to rabbits.
- Executive summary:
The potential of di-tert-butyl polisulfides (TPS 44) to induce skin irritation was evaluated in rabbits according to OECD No. 404 and EC (2004/73/EC, B.4) guidelines and in compliance with the principles of GLP. TPS 44 was first applied for periods of 3 minutes, 1 hour and 4 hours to a single male New Zealand White rabbit. Since the test item was not severely irritant on this first animal, it was then applied for 4 hours to two other animals. A single dose of 0.5 mL of undiluted TPS 44 was applied to the closely-clipped skin of one flank. TPS 44 was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until the end of the observation period. The mean values of the scores for erythema and edema were calculated for each animal.
After a 3-minute exposure (one animal), a very slight or well-defined erythema was noted from day 1 up to the end of the observation period (day 15). A very slight or slight edema was observed from day 3 up to day 9 and dryness of the skin was also recorded from day 5 up to the end of the observation period (day 15). After a 1-hour exposure (one animal), a very slight or well-defined erythema was noted from day 1 up to the end of the observation period (day 15). A very slight or slight edema was observed from day 4 up to day 9 and dryness of the skin was also recorded from day 6 up to the end of the observation period (day 15). After a 4-hour exposure (three animals), a very slight or well-defined erythema was noted in all animals from day 1 up to day 12, 13 or 15 (end of the observation period). A very slight or slight edema was observed in 2/3 animals from day 1 up to day 3 or 7 and dryness of the skin was also recorded in all animals between days 5 and 15 (end of the observation period). Mean scores over 24, 48 and 72 hours for each animal were 2.0, 2.0 and 2.0 for erythema and 0.0, 1.0 and 2.0 for edema.
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