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EC number: 219-702-5 | CAS number: 2500-88-1
- 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
Description of key information
Acute toxicity after single oral application was tested in female rats, which received 15,000 mg/kg bw. No animal died or showed clinical symptoms/macroscopic anomalies. The necropsy did not reveal any effect. The LD50 value for acute oral toxicity was considered to be greater than 15,000 mg/kg bw. Due to the findings described above (LD50 oral in rats greater than 15,000 mg/kg bw) dioctadecyl disulphide does not have to be classified as acute orally toxic.
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:
- Nov - Dec 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically acceptable; study equivalent to OECD Guideline 401 with minor deviation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- only females tested
- GLP compliance:
- no
- Remarks:
- performed before GLP guidelines
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Hoechst AG Kastengrund - SPF breed
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG Kastengrund - SPF breed
- Weight at study initiation: 93 - 107g
- Fasting period before study: 16 hours before and 2 hours after application
- Housing: in plastic cages, softwood pellets
- Diet (e.g. ad libitum): Altromin 1324 (Altrogge GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): Tap water ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- - concentration in vehicle: 25 % (w/v)
- Doses:
- 15000 mg/kg bw
- No. of animals per sex per dose:
- 10 female rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations after application / Weighing once weekly
- Necropsy of survivors performed: yes - Statistics:
- no
- Preliminary study:
- An acute oral toxicity study with female rats was performed in 1964. The LD(50) dreived was 15000 mg/kg bw.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 15 000 mg/kg bw
- Remarks on result:
- other: no effects
- Mortality:
- no deaths occured
- Clinical signs:
- other: no symptoms
- Gross pathology:
- no anomalies
- Other findings:
- no
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose of Hostanox SE 10 (LD50) was greater than 15000 mg per kg body weight. Based on the result of this study the test item is not subject for labelling and classification requirements according to regulatory requirements.
- Executive summary:
Hostanox SE 10 was tested for its acute toxic properties in female rat via oral route. No animal died or showed clinical symptoms/macroscopic anomalies after application of 15000 mg/kg bw.
Therefore, the median lethal dose of Hostanox SE 10 (LD50) was greater than 15000 mg per kg body weight. Based on the result of this study the test item is not subject for labelling and classification requirements according to regulatory requirements.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 15 000 mg/kg bw
- Quality of whole database:
- 2 (reliable with restrictions)
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Based on the results of an oral toxicity study the LD50 value for acute oral toxicity was considered to be greater than 15,000 mg/kg bw.
In
accordance with REACH “Column 2” in Annex VIII there is sufficient
weight of evidence from several independent sources of information
leading to the conclusion that Dioctadecyl disulphide does not exert
systemic toxic effects after acute inhalation exposure and thus does not
have to be classified, because
- the LD50 value for acute oral toxicity of Dioctadecyl disulphide is
greater 15,000 mg/kg bw,
- Dioctadecyl disulphide does not have to be classified as skin
irritating,
- inhalation to consumer is very unlikely to occur, since the substance
is embedded in polymeric matrices for consumer applications and
- occupational health surveillance data obtained from workers of the
production site do not give any hint concerning adverse systemic effects
and effects on the respiratory tract (for expert statement please refer
to Chapter 7.10.1).
Therefore, it is concluded that testing of acute inhalation toxicity of
Dioctadecyl disulphide salt is not scientifically necessary.
It can reasonably be deduced that Dioctadecyl disulphide does not exert systemic toxic effects after dermal application and thus does not have to be classified, because this substance did not cause lethal effects after administration of a single oral dose of up to 15,000 mg/kg bw in rats. Furthermore the substance does not have to be classified as skin irritating. Due to the combination of its polar character (Sulfur bridge in the center of the molecule) and the long extent of the alkyl chain it is unlikely that higher amounts (limit dose of dermal toxicity testing according OECD 402: 2,000 mg/kg bw/d) than tested in the acute oral toxicity study (tested up to 15,000 mg/kg bw/d) will be systemically available via the intact skin barrier even if the most unlikely amount of 100% penetration is assumed. Therefore, testing is not scientifically necessary.
Justification for selection of acute toxicity – oral endpoint
Scientifically acceptable; study equivalent to OECD Guideline 401
Justification for selection of acute toxicity – inhalation endpoint
n.a.
Justification for selection of acute toxicity – dermal endpoint
n.a.
Justification for classification or non-classification
Due to the findings described in the acute oral toxicity study (LD50 oral in rats greater than 15,000 mg/kg bw) Dioctadecyl disulphide does not have to be classified as acute orally toxic. Based on the substance's physico-chemical and non-irritant properties, as well as the unlikeliness of exposure and the experience from occupational health surveillance no higher systemic exposure via inhalation or dermal penetration is expected to occur than that tested in the course of the oral toxicity study. Therefore, Dioctadecyl disulphide does not have to be classified as acute toxic.
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