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EC number: 234-196-6 | CAS number: 10591-84-1
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
In a subacute oral study in rats dosed up to and including 1000 mg/kg bw/day no effects on reproductive organs were detected.
Link to relevant study records
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Reproductive effects observed:
- not specified
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- a study according to OECD Guideline and GLP with Klimisch score 1
Additional information
Studies dealing specifically with toxicity to reproduction (fertility assessment) of N,N-Dimethyldiphenylthiuram Disulphide are not identified. In addition, there is no screening study according to OECD TG 421 available. However there is a Repeated Dose Toxicity Study available in rats over a period of 28 days in which rats were dosed up to and including 1000 mg/kg bw/day in which the reproductive oragans are examinde histopathologically. A test according to OECD TG 414 (Developmental Toxicity) is proposed
As confirmed by literature (Mangelsdorf et al 2003, Ulbrich & Palmer 1995, Janer et al 2007a, Dent 2007) histopathological examinations in repeated dose toxicity are of high value and high sensitivity for evaluation of reproductive toxicity. Therefore, at least for fertility assessment, repeated dose toxicity study showing no adverse effect should be taken into account. Also it is agreed that histopathological changes on the reproductive organs in repeated dose toxicity studies are indicative of effects on fertility. Therefore repeated dose toxicity studies should be considered sufficient information to evaluate toxicity on fertility if histological examination of the reproductive organs is covered by the repeated dose toxicity study and the mode of action of the test stubstance does not give evidence for a specific toxicity (as would e.g. sex hormone receptor binding activity).
For N,N-Dimethyldiphenylthiuram Disulphide a 28-day study is available (Wirnitzer 2012). During the 28-days treatment period male and female Wistar rats received 0, 100, 300 or 1000 mg/kg bw/day N,N-Dimethyldiphenylthiuram Disulphide dissolved inSokutol/Ethanol/water(4:1:5) water by gavage. The study was performed according to OECD TG 407 and GLP. Reproductive organs of the rats of the highest dose group and of the control animals were examined histopathologically. No adverse effects were noted from these organs in these groups. Based on these results there are no indications for specific adverse effects on the reproductive organs up to and including 1000 mg/kg bw/day
In conclusion, due to the lack of adverse effects on reproductive organs up to and including the limit dose of 1000 mg/kg bw/day over 28 days, there is no indication of a specific toxic potential in the reproductive organs . Therefore, based on the considerations above, no further testing should be required for fertility assessment.
Furthermore, a developmental toxicity study (rat, oral) according to OECD TG 414 will be conducted after approval by ECHA.
Therefore, the requirements of Regulation (EC) 1906(2006) ANNEX VIII and IX are fulfilled.
References
Mangelsdorf. et al., 2003: Some aspects relating to the evaluation of the effects of chemicals on male fertility. Regulatory toxicology and Pharmacology 36, 69-98
Ulbrich & Palmer, 1995: Detection of effects on male reproduction – a literature survey. J am. College of Toxicology 14, 293-327
Janer et al., 2007: A retrospective analysis of the added value of the rat two-generation reproductive toxicity study versus the rat subchronic toxicity study. Reproductive Toxicology 24, 103-113
Dent, 2007: Strength and limitations of using repeated-dose toxicity studies to predict effects on fertility. Regulatory Toxicology and Pharmacology 48, 241-258
Short description of key information:
Studies dealing specifically with toxicity to reproduction (fertility assessment) of N,N-Dimethyldiphenylthiuram Disulphide are not identified. In addition, there is no screening study according to OECD TG 421 available. However in the available subacute oral rat study doses up to and including 1000 mg/kg bw/day did not cause any adverse effects on reproductive organs (NOAEL: 1000 mg/kg bw/day). A test according to OECD TG 414 (Developmental toxicity) and GLP id ptoposed.
Justification for selection of Effect on fertility via oral route:
There is no specific study on fertility assessment available
For N,N-Dimethyldiphenylthiuram Disulphide a 28-day study is available (Wirnitzer 2013). During the 28-days treatment period male and female Wistar rats received 0, 100, 300 or 1000 mg/kg bw/day N,N-Dimethyldiphenylthiuram Disulphide dissolved in Sokutol/Ethanol/water(4:1:5) water by gavage. The study was performed according to OECD TG 407 and GLP. Reproductive organs of the rats of the highest dose group and of the control animals are examined histopathologically. No adverse effects were noted from these organs in these groups. Based on these results there are no indications for specific adverse effects on the reproductive organs up to and including 1000 mg/kg bw/day
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available (further information necessary)
Additional information
A study according to OECD TG 414 (rat, oral) is planned after approval by ECHA
Justification for selection of Effect on developmental toxicity: via oral route:
a study according to OECD TG 414 (rat, oral) is planned after approval by ECHA
Toxicity to reproduction: other studies
Additional information
For N,N-Dimethyldiphenylthiuram Disulphide a 28-day study is available (Wirnitzer 2012). During the 28-days treatment period male and female Wistar rats received 0, 100, 300 or 1000 mg/kg bw/day N,N-Dimethyldiphenylthiuram Disulphide dissolved in Sokutol/Ethanol/water(4:1:5) by gavage. The study was performed according to OECD TG 407 and GLP. Reproductive organs of the rats of the highest dose group and of the control animals were examined histopathologically. No adverse effects were noted from these organs in these groups. Based on these results there are no indications for specific adverse effects on the reproductive organs up to and including 1000 mg/kg bw/day
Justification for classification or non-classification
No classification and labelling is required
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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