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EC number: 478-900-1 | CAS number: 6156-18-9
- 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 potential of 2,2-Bis(methylthio)propane to induce delayed contact hypersensitivity was evaluated in guinea pigs according to the maximization method of Magnusson and Kligman and to OECD guideline 406 (Rokh, 2007d). The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. Thirty guinea pigs were allocated to two groups: a control group of five males and five females and a treated group of ten males and ten females. On day 1, three pairs of intradermal injections were performed in the interscapular region of all animals.
Freund's complete adjuvant (FCA) diluted to 50% (v/v) with 0.9% NaCl (both groups).
2,2-Bis(methylthio)propane at the concentration of 10% in corn oil (treated group) or vehicle alone (control group).
2,2-Bis(methylthio)propane at the concentration of 10% in a mixture FCA/0.9% NaCl (50/50, w/w) (treated group) or vehicle at the concentration of 50% (w/v) in a mixture FCA/0.9% NaCl (50/50, v/v) (control group).
On day 8, the animals of the treated group received a topical application of the undiluted 2,2-Bis(methylthio)propane to the same test site, which was then covered by an occlusive dressing for 48 hours. The animals of the control group received an application of the vehicle (ethanol/water (80/20, w/w) under the same experimental conditions. On day 22, all animals of both groups were challenged by a cutaneous application of 2,2-Bis(methylthio)propane at the concentration of 10% (w/w) in acetone to the right flank. BMTP was maintained under an occlusive dressing for 24 hours. The vehicle was applied to the left flank under the same experimental conditions. Skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing. At the end of the study, the animals were killed without examination of internal organs. No deaths and no clinical signs were noted during the study. No cutaneous reactions were observed after the challenge application of BMTP. Under the experimental conditions of this study and according to the maximization method of Magnusson and Kligman, 2,2-Bis(methylthio)propane did not induce delayed contact hypersensitivity in guinea pigs.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed before the implementation of the REACH regulation
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, L’Arbresle, France
- Age at study initiation: 1-2 months old
- Weight at study initiation:
Male: 352 +/- 12 g
Female: 354 +/-21 g
- Housing: housed individually in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm)
- Diet: free access to 106 pelleted diet (SAFE, Villemoisson, Epinay sur-Orge, France)
- Water: water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 to 70
- Air changes (per hr):12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From 20 December 2006 to 02 February 2007 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: corn oil (i.d. induction) and acetone (challenge)
- Concentration / amount:
- Induction:
- 10% in corn oil intradermal
- undiluted topically
Challenge:
10% (w/w) in acetone topically - Route:
- epicutaneous, occlusive
- Vehicle:
- other: corn oil (i.d. induction) and acetone (challenge)
- Concentration / amount:
- Induction:
- 10% in corn oil intradermal
- undiluted topically
Challenge:
10% (w/w) in acetone topically - No. of animals per dose:
- Test group: 20
Negative control group: 10 - Details on study design:
- RANGE FINDING TESTS:
By intradermal route: tested concentrations: 25%, 10% and 5% (w/w)
By cutaneous route
Under the conditions of the induction phase: tested concentrations: 100% and 50% (w/w)
Under the conditions of the challenge phase: tested concentrations: 100%, 50%, 25% and 10% (w/w) - Challenge controls:
- The vehicle was applied under the same experimental conditions to the skin of the posterior left flank.
- Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole
- Positive control results:
- Mercaptobenzothiazole induced positive skin sensitization reactions in 100% (10/10) guinea pigs
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The potential of BISMETHYLTHIOPROPANE (BMTP) to induce delayed contact hypersensitivity was evaluated in guinea pigs according to the maximization method of Magnusson and Kligman and to OECD guideline 406. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. Thirty guinea pigs were allocated to two groups: a control group of five males and five females and a treated group of ten males and ten females. On day 1, three pairs of intradermal injections were performed in the interscapular region of all animals:
. Freund's complete adjuvant (FCA) diluted to 50% (v/v) with 0.9% NaCl (both groups),
. BMTP at the concentration of 10% in corn oil (treated group) or vehicle alone (control group),
. BMTP at the concentration of 10% in a mixture FCA/0.9% NaCl (50/50, w/w) (treated group) or vehicle at the concentration of 50% (w/v) in a mixture FCA/0.9% NaCl (50/50, v/v) (control group).
On day 8, the animals of the treated group received a topical application of the undiluted BMTP to the same test site, which was then covered by an occlusive dressing for 48 hours. The animals of the control group received an application of the vehicle (ethanol/water (80/20, w/w) under the same experimental conditions. On day 22, all animals of both groups were challenged by a cutaneous application of BMTP at the concentration of 10% (w/w) in acetone to the right flank. BMTP was maintained under an occlusive dressing for 24 hours. The vehicle was applied to the left flank under the same experimental conditions.Skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing. At the end of the study, the animals were killed without examination of internal organs.
No deaths and no clinical signs were noted during the study. No cutaneous reactions were observed after the challenge application of BMTP. Under the experimental conditions of this study and according to the maximization method of Magnusson and Kligman, BISMETHYLTHIOPROPANE did not induce delayed contact hypersensitivity in guinea pigs.
Reference
Signs of irritation during induction:
yes
Evidence of sensitisation of each challenge concentration:
No cutaneous reactions were observed after the challenge
application of the test item.
Other observations:
No deaths and no clinical signs were noted during the study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to REGULATION (EC) No 1272/2008 criteria, no classification is warranted for skin sensitisation.
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