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EC number: 248-468-7 | CAS number: 27458-90-8
- 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
Acute oral toxicity
The potential acute toxicity of DI-TERT-DODECYL DISULPHIDE was evaluated following a single oral administration (gavage) to rats (Papineau, 2016). This study was conducted in compliance with OECD Guideline No. 423 and the principles of Good Laboratory Practices. The test item was administered once by oral route (gavage) to two groups of three fasted female Sprague-Dawley rats under a dosage-volume of 10 mL/kg. The test item was prepared in corn oil. Based on the expected low toxicity of the test item data, the starting dose-level of 2000 mg/kg was chosen. After the first assay, as no mortality was observed, the results were confirmed in other females treated at the same dose-level. Each animal was observed at least once a day for mortality and clinical signs for 15 days. Body weight was recorded on Day 1 and then on Days 8 and 15. On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination. No tissues were preserved.
No unscheduled deaths occurred during the study. At 2000 mg/kg, piloerection together with dyspnea were observed on Day 1, in the first 4 hours after treatment in 3/6 females. No clinical signs were noted in the remaining 3/6 females treated at the same dose-level. Compared to historical control data, body weight change and body weight of the animals were considered to be unaffected by the test item treatment. At the end of the observation period, there were no macroscopic findings at necropsy. Under the experimental conditions of this study, the oral LD0 of DI-TERT-DODECYL DISULPHIDE was higher than 2000 mg/kg in rats.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 December 2015 -- 02 February 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder: Janvier, Le Genest-Saint-Isle, France.
- Age/Weight: on the day of treatment, the females were 8 weeks old and had a mean body weight of 216 g (range: 200 g to 230 g).
- Fasting period before study: yes, during the night before treatment
- Housing: polycarbonate cages
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: for a period of 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 8 to 15 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: 12 January 2016 to 02 February 2016 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Justification for choice of vehicle: in the absence of recommendation from the Sponsor, the solubility assay first started at the concentration of 200 mg/mL, and the first choice vehicle was drinking water treated by reverse osmosis.
As unsatisfactory solubility of the test item was obtained in this vehicle (i.e. heterogeneous emulsion at the concentration of 200 mg/mL was obtained), another vehicle was chosen from the following organic solvents (in order of preference): 0.5% methylcellulose aqueous solution and corn oil.
A heterogeneous emulsion was observed with 0.5% methylcellulose aqueous solution, and corn oil was chosen since it allowed obtaining a homogeneous emulsion at the concentration of 200 mg/mL.
- Maximum dose-volume applied: 10 mL/kg
DOSAGE PREPARATION (if unusual): fresh dose formulations were prepared by the CiToxLAB France Pharmacy on the day of each administration.
The dose formulations were stored at room temperature and delivered to the study room in glass flasks.
CLASS METHOD (if applicable):
- Rationale for the selection of the starting dose: 2000 mg/kg - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 6 (2x3 females per treatment step)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Clinical observations: frequently during the hours following treatment; then, at least once a day.
- Body weight: just before treatment on day 1; then on days 8 and 15.
- Necropsy of survivors performed: yes (macroscopic). - Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No unscheduled deaths occurred during the study.
- Clinical signs:
- other: At 2000 mg/kg, piloerection together with dyspnea were observed on Day 1, 1 to 3 hours after treatment in 2/6 females. These signs persisted 4 hours after treatment and were also observed in a third female at the 4 hours time-point only. No clinical signs
- Gross pathology:
- No macroscopic findings were observed at the end of treatment period.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- Under the experimental conditions of this study, the oral LD0 of the test item was higher than 2000 mg/kg in rats.
- Executive summary:
The potential acute toxicity of DI-TERT-DODECYL DISULPHIDE was evaluated following a single oral administration (gavage) to rats. This study was conducted in compliance with OECD Guideline No. 423 and the principles of Good Laboratory Practices. The test item was administered once by oral route (gavage) to two groups of three fasted female Sprague-Dawley rats under a dosage-volume of 10 mL/kg. The test item was prepared in corn oil. Based on the expected low toxicity of the test item data, the starting dose-level of 2000 mg/kg was chosen. After the first assay, as no mortality was observed, the results were confirmed in other females treated at the same dose-level. Each animal was observed at least once a day for mortality and clinical signs for 15 days. Body weight was recorded on Day 1 and then on Days 8 and 15. On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination. No tissues were preserved.
No unscheduled deaths occurred during the study. At 2000 mg/kg, piloerection together with dyspnea were observed on Day 1, in the first 4 hours after treatment in 3/6 females. No clinical signs were noted in the remaining 3/6 females treated at the same dose-level. Compared to historical control data, body weight change and body weight of the animals were considered to be unaffected by the test item treatment. At the end of the observation period, there were no macroscopic findings at necropsy. Under the experimental conditions of this study, the oral LD0 of DI-TERT-DODECYL DISULPHIDE was higher than 2000 mg/kg in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP guideline study
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
DI-TERT-DODECYL DISULPHIDE should not be classified regarding its toxic potential by oral route according to the criteria of CLP and GHS Regulations.
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