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EC number: 404-310-0 | CAS number: 10591-85-2 PERKACIT TBZTD; PERKACIT TBZTD PDR; PERKACIT TBZTD PDR-D; TBZD
- 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
Based on guinea pigs study, Tetrabenzylthiuram disulfide is not considered as a skin sensitizer.
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:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- As described in the Annex of EEC Directive 84/449 of 25 April 1984
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- OECD Testing Guideline 406, adopted on 12 May 1981
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- split adjuvant test
- Justification for non-LLNA method:
- The skin sensitisation study on guinea pigs was performed before REACH regulation.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Thirty-five young adult female guinea pigs of the Dunkin-Hartley strain, approximately 2 months old at the start of the experiment, SPF-quality, were obtained from Charles River Wiga, FRG. The animals were nulliparous and non-pregnant; they were identified by means of a tattoo behind the ears.
A few days before the start of the experiment, the bodyweights ranged from 292 to 437 g (see Tables 1 and 2). The animals were housed in metal cages with wire-mesh floors (ITL, Bergen, The Netherlands; 2 animals per cage). They were fed standard guinea pig diet, including ascorbic acid (1600 mg/kg) obtained from Hope Farms, Woerden, The Netherlands (LC 23-B, pellet diameter 4 mm) and had free access to tap-water (via automatic nozzles). Certificates of analyses for both diet and drinking water are retained in the RCC NOTOX archives. In addition, once a week hay was provided.
The animal room temperature was between 19 and 22°c and the relative humidity between 60 and 80 per cent. The artificial light sequence was 12 hours light, 12 hours dark.
A combined quarantine/acclimatisation period of 13 days was allowed (7 days for the animals of the primary irritation experiment). - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25% (w/w) in milli-RO water
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 50%, 25%, 5% and 0% (w/w)
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Details on study design:
- Primary irritation experiment
A primary irritation test was carried out using five guinea pigs to determine the concentrations to be applied in the challenge phase (these should not produce any substantial irritation). Four guinea pigs were shaved and their flank was exposed for 24 hours in an amount of 0.05 ml to 50%, 25%, 10% and 5% (w/w) of the test substance in aqueous methyl cellulose 1% occlusively administered by means of
four Square chambers (v.d. Bend, Brielle, The Netherlands).
One additional animal was treated epicutaneously with 0.5 ml of the test substance, 50% in aqueous methyl cellulose 1%, on a patch of Metalline (Lohmann, W.-Germany) for evaluation of the toxicity of the compound. In this case, the test substance caused no skin irritation.
No systemic toxic effects resulted from these treatments in any of the animals
Induction
The experimental animals had an area of skin clipped and shaved on the back behind the right shoulder. The animal was wrapped in a "window dressing" which consisted of Cohan elastic bandage (Smith and Nephew, England). A 2 x 2 cm opening was cut in the dressing over the exposure site. Dry ice was applied to the test site for approximately 5 sec with firm pressure. Then 0.2 ml of test substance, 25% (w/w) in Milli-RO water was applied and this was covered with a Metalline patch (Lohmann). The patch was then covered with water-impervious tape (Sleek, Smith and Nephew, England).
On day 2, the dressing covering the window was removed, 0.2 ml of the test material in Milli-RO water was applied, and the window reclosed with the same dressing.
On day 4, the window was again opened and 0.1 ml of Freund's complete adjuvant (Difeo, Detroit, USA) injected intradermally on both sides of the exposure site. This was followed by a further application of 0.2 ml of the test substance in Milli-RO water, and the window closed.
On day 7, the test material was again applied.
On day 9, all wrappings were removed.
(On day 4, the negative control animals received intradermal injections of Freund's complete adjuvant to exclude interpretation difficulties in the challenge phase caused by a specific lowering of the skin irritation threshold by this substance).
Challenge
On day 21, the flank was carefully shaved and the protruding long hairs from the edges cut away with scissors. The test substance, suspended in Milli-RO water, was applied in a volume of 0.05 ml on Square chambers (v.d. Bend, Brielle, The Netherlands), mounted on Micropore-tape. Each animal received 4 different concentrations of test substance; all animals were treated similarly.
The concentrations tested were: 50%, 25%, 5% and 0% (w/w) of the test substance in Milli-RO water. The elastic bandage (Cohan) was kept in place for 24 hours.
Twenty-four and fourty-eight hours after removal of the dressings, readings were made.
If considered necessary for the proper evaluation of skin reaction, the treated side of all animals was shaved after the first reading on day 23. - Challenge controls:
- Positive controls were carried out regularly to show the proficiency of the testing facility and the sensitivity of the strain of guinea pigs, in accordance with the OECD Testing Guideline 406 and EEC test method B.6, Methods for the Determination of Toxicity, "Acute toxicity - skin sensitization", as described in the Annex of EEC Directive 84/449 of 25 April 1984.
- Positive control substance(s):
- yes
- Remarks:
- A positive control experiment was carried out in February 1987 (RCC NOTOX Study Ref. No. 0000/663) using solutions of formaldehyde 37% at 5%, 2% and 0.5% (w/w) in milli-RO water.
- Positive control results:
- A sensitisation rate of 50% was obtained with the 0.5% concentration.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not skin sensitizer
- Conclusions:
- The results indicate a sensitization rate of 0%. It is therefore improbable that the test substance has sensitizing properties.
- Executive summary:
Tetrabenzylthiuram disulfide (TBzTD) was tested in the Split Adjuvant Test to determine its sensitizing potential.
Adult female guinea pigs (Dunkin-Hartley strain) were induced by epicutaneous applications of the test substance, 25% (w/w) in Milli-RO water. After being challenged with a series of test substance concentrations (50%, 25% and 5%) in Milli-RO water, no positive response (grade 2 or more) was observed to the concentrations tested in any of the animals.
These results indicate a sensitization rate of 0%. It is therefore improbable that the test substance has sensitizing properties.
Reference
Maximum concentration not causing irritating effects in preliminary test.
Signs of irritation during induction: None
Evidence of sensitation of each challenge concetration: None
Other observations:
Red spots (signs of irritation were observed in 3 test animals at concetrations 50% (24 and 48 hrs), 25% (48 hrs) and 0% (48 hrs) respectively and in one controlanimal (48 hrs). No signs of systemic toxicity were observed in any of the animals during the study period.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Tetrabenzylthiuram disulfide (TBzTD) was tested in the Split Adjuvant Test to determine its sensitizing potential.
Adult female guinea pigs (Dunkin-Hartley strain) were induced by epicutaneous applications of the test substance, 25% (w/w) in Milli-RO water. After being challenged with a series of test substance concentrations (50%, 25% and 5%) in Milli-RO water, no positive response (grade 2 or more) was observed to the concentrations tested in any of the animals.
These results indicate a sensitization rate of 0%. It is therefore improbable that the test substance has sensitizing properties.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, Tetrabenzylthiuram disulfide should not be classified as skin sensitizer according to the Regulation EC n°1272/2008.
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