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EC number: 249-047-0 | CAS number: 28473-19-0
- 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
Carcinogenicity
Administrative data
Description of key information
No standard carcinogenicity studies are available on DIDS (or DIDA, DEHS or DOS). However, in a limited study, no treatment-related increase in the incidence of gross or microscopic lesions or abnormalities was seen in rats receiving about 10 mg DOS/kg bw/day (the study NOAEL) from the diet for up to 19 months (Le Breton, 1952-7). No evidence of tumour promoting activity was seen with DEHS in rats (Oesterle and Deml, 1988).
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- No data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study on a read-across compound, reported in the secondary literature (limited reporting). Only one (relatively low) dose level tested (about 10 mg/kg bw/day) (at least three dose levels are recommended by the OECD guideline) and testing conducted for up to 19 months (less than the recommended 24 months for rats)
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Rats were fed for up to 19 months with DOS at 200 mg/kg via the diet. Only one (relatively low) dose level tested (about 10 mg/kg bw/day). Unspecified organs were examined for gross and/or microscopic lesions at necropsy. Possibly performed as part of a four-generation study; animals may have also been mated and/or exposed in utero over the course of the study.
- GLP compliance:
- no
- Remarks:
- predates GLP
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Up to 19 months
- Frequency of treatment:
- Presumably daily (given in the diet)
- Post exposure period:
- No data in citing sources
- Remarks:
- Doses / Concentrations:
200 mg/kg diet
Basis:
nominal in diet
(equivalent to about 10 mg/kg bw/day for adult rats, and 20 mg/kg bw/day for young rats) - No. of animals per sex per dose:
- No data in citing sources
- Control animals:
- yes
- Relevance of carcinogenic effects / potential:
- No treatment-related increase in tumour incidence was observed. But only a single, relatively low, dose of 10 mg/kg bw was tested (3 dose levels are recommended by the relevant OECD guideline), and rats were only treated for up to 19 months (as opposed to the recommended 24 months).
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects observed
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Conclusions:
- Secondary sources briefly describe a pre-GLP chronic dietary study on DOS, a structurally-related read-across compound for DIDS. No treatment-related increase in the incidence of gross or microscopic lesions or abnormalities was seen in rats recieving about 10 mg/kg bw/day (the study NOAEL) from the diet for up to 19 months.
- Executive summary:
A pre-GLP chronic dietary study has been conducted on DOS, a structurally-related read-across compound for DIDS, and is briefly reported in the secondary literature.
Wistar rats were fed DOS at the relatively low level of 200 mg/kg diet (about 10 mg/kg bw/day) for up to 19 months [no further details in citing sources; OECD guidelines recommend treatment with at least 3 dose levels for 2 years in rats].
Animals were subject to gross and histological examination upon necropsy [although the extent of this examination is not given]. No increased incidence of gross or microscopic lesions was reported, and the authors concluded that DOS lacked carcinogenic action.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 10 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- No relevant carcinogenicity data were available on laboratory animals given repeated oral treatment with DIDS. Regarding read-across data, a limited chronic study with DOS is available, as is a tumour-promotion study on DEHS.
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No data were available on DIDS (or DIDA), although QSAR analysis predicts that DIDS is not carcinogenic. In addition, no carcinogenic effects were seen in a limited study in which rats received DOS at about 10 mg/kg bw/day from their diet for 19 months, and no tumour promotion activity was seen for DEHS in a rat liver foci test . These findings indicate that DIDS does not warrant classification as a carcinogen under CLP Regulation (EC) 1272/2008 or the Dangerous Substances Directive 67/548/EEC.
Additional information
No standard carcinogenicity studies are available on DIDS (or DIDA, DEHS or DOS).
The OECD QSAR Toolbox identified no structural alerts for genotoxic or non-genotoxic carcinogenicity (by ISS) for DIDS. No carcinogenicity was predicted by QSAR models from the Danish EPA DB in male and female rats and mice (with TD50 values of 1000 mg/kg bw/day) (OECD, 2012).
Relevant read-across data:
A pre-GLP chronic dietary study conducted on DOS is briefly reported in the secondary literature. Wistar rats were fed DOS at the relatively low level of 200 mg/kg diet (about 10 mg/kg bw/day) for up to 19 months [no further details in citing sources; OECD guidelines recommend treatment with at least 3 dose levels for 2 yr in rats]. Animals were subject to gross and histological examination upon necropsy [although the extent of this examination is not given]. No increased incidence of gross or microscopic lesions was reported, and the authors concluded that DOS lacked carcinogenic action. The NOAEL for carcinogenicity can therefore be considered about 10 mg/kg bw/day in this limited study (Le Breton, 1952-7).
No evidence of tumour promotion activity was seen in a rat liver foci test in which DEHS was orally administered to rats (5/sex/group) at 500 mg/kg bw, on three occasions per wk for 11 wk, following pre-treatment with a single oral administration of a known carcinogen (Oesterle and Deml, 1988).
References
Oesterle D and Deml E (1988). Promoting activity of di(2 -ethylhexyl) phthalate in rat liver foci bioassay. Journal of Cancer Research and Clinical Oncology 114, 133 -13
Justification for selection of carcinogenicity via oral route
endpoint:
Limited chronic study on a read-across compound.
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