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EC number: 460-390-7 | CAS number: 26504-29-0
- 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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, OECD N°406 Guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed before the implementation of the REACH regulation.
Test material
- Reference substance name:
- -
- EC Number:
- 460-390-7
- EC Name:
- -
- Cas Number:
- 26504-29-0
- Molecular formula:
- C15H14S3
- IUPAC Name:
- bis(benzylsulfanyl)methanethione
- Details on test material:
- - Name of test material (as cited in study report): DIBENZYL TRITHIOCARBONATE
- Physical state: yellow orange-colored solid
- Analytical purity: 96.2
- Purity test date: 2003-10-27
- Lot/batch No.: 1 UG 114
- Expiration date of the lot/batch: November 2004
- Storage condition of test material: at room temperature and protected from light
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 2 months old
- Weight at study initiation: 380 ± 15 g for the males and 302 ± 13 g for the females
- Housing: individually in polycarbonates cages (48x27x20cm)
- Diet (e.g. ad libitum): ad libitum "106 pelleted diet" (U.A.R., 91360 Villemoisson-sur-Orge, France)
- Water (e.g. ad libitum): ad libitum drinking water filtered with a 0.22µ membrane (Société Millipore, 78140 Velizy, France)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3°C
- Humidity (%): 50+/-20%
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: The vehicle used for intradermal injections was corn oil. For topical applications (induction phase and challenge application), the vehicle used was acetone.
- Concentration / amount:
- intradermal induction: 0.1 %
cutaneous induction: 50 %
cutaneous challenge: 25 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: The vehicle used for intradermal injections was corn oil. For topical applications (induction phase and challenge application), the vehicle used was acetone.
- Concentration / amount:
- intradermal induction: 0.1 %
cutaneous induction: 50 %
cutaneous challenge: 25 %
- No. of animals per dose:
- Control group: 5 males and 5 females
Treated group: 10 males and 10 females - Details on study design:
- RANGE FINDING TESTS:
Tested concentrations:
Intradermal test: 10%, 5%, 2.5%, 1% and 0.1% (w/w)
Cutaneous test: 50% and 25% (w/w)
MAIN STUDY
A. INDUCTION EXPOSURE
* Intradermal induction:
- On day 1, 3injections are realized on the scapular area:
- 0.1mL of Freund's complete adjuvant at 50% in 0.9%NaCl
- 0.1mL of the test item at 0.1 % (for treated group) or 0.1mL of vehicle (for control group)
- 0.1mL of a mixture 50/50 (V/V) of Freund's complete adjuvant in 0.9% NaCl and the test item at 0.1 % (for treated group) or the vehicle (for control group).
* Cutaneous induction:
- On day 7, local irritation is induced by application of Sodium Laurylsulfate 10% in Vaseline
- On day 8, occlusive application on the scapular area of 0.5mL of the test item 50% (for treated group) or vehicle (for control group) for 48hours
B. CHALLENGE EXPOSURE D22
On day 22, 24hours occlusive application on the scapular area of 0.5mL of the test item 25% on the right flank and 0.5mL of the vehicle on the left flank.
Reactions are evaluated 24 and 48 hours after removal of the dressing - Challenge controls:
- No
- Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole (CIT/Study No. 26182 RDG - September 2003)
Results and discussion
- Positive control results:
- Mercaptobenzothiazole : Positive result in recent study on 10/10 females. Induction: test substance injected intradermally 1.0 (d1) and applied cutaneously 20% (d8). Challenge (d22): 20% r flank 0.5% l flank
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- discrete erythema (grade 1)
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- a discrete or moderate erythema (grade 1 or 2)
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- a discrete or moderate erythema (grade 1 or 2)
- Remarks on result:
- positive indication of skin sensitisation
- 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
Any other information on results incl. tables
A discrete erythema (grade 1) was observed in 2/10 animals of the control group, at the 24-hour reading only.
In the treated group, a discrete or moderate erythema (grade 1 or 2), together with an oedema in one animal, was noted at the 24-hour reading in 17/20 and 2/20 animals, respectively. At the 48-hour reading, a discrete or moderate erythema (grade 1 or 2), together with dryness of the skin in two animals, persisted in 7/20 and 2/20 animals, respectively.
The persistent cutaneous reactions observed in 9/20 animals of the treated group were attributed to delayed contact hypersensitivity.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- DIBENZYL TRITHIOCARBONATE induces delayed contact hypersensitivity in 9/20 (45%) guinea pigs, and should therefore be considered as a moderate sensitizer
- Executive summary:
The delayed contact hypersensivity of DIBENZYL TRITHIOCARBONATE was evaluated in Guinea pigs according to OECD N°406 guideline (Magnusson and Kligman test).
The induction phase has been realized both by intradermal route on day 0.1 (% in vehicle) and by cutaneous route on day 50 (%) in 2 groups of guinea pigs: 5 males and 5 females for control group and 10 males and 10 females for treated group. The challenge phase was realized on day 22 by cutaneous application of 25 % on the right flank (vehicle on the left flank); the cutaneous reactions were scored 24 and 48 hours after the challenge phase.
After the challenge application, a discrete erythema was observed in 2/10 animals of the control group, at the 24-hour reading only.
In the treated group, a discrete or moderate erythema, together with an oedema in one animal, was noted at the 24-hour reading in 17/20 and 2/20 animals, respectively. At the 48-hour reading, a discrete or moderate erythema, together with dryness of the skin in two animals, persisted in 7/20 and 2/20 animals, respectively. The persistent cutaneous reactions observed in 9/20 animals of the treated group were attributed to delayed contact hypersensitivity.
Under the experimental conditions of the maximization method of Magnusson and Kligman, DIBENZYL TRITHIOCARBONATE induces delayed contact hypersensitivity in 9/20 (45%) guinea pigs, and should therefore be considered as a moderate sensitizer.
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