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Diss Factsheets
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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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Remarks:
- in silico
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Study period:
- Not applicable
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD agreed method. No explicit domain available.
- Justification for type of information:
- QSAR prediction: migrated from IUCLID 5.6
- Qualifier:
- according to guideline
- Guideline:
- other: REACH guidance on QSARs R.6, May 2008
- Principles of method if other than guideline:
- Danish EPA DB was used, via the OECD QSAR Toolbox (v.3.0), to predict whether diisodecyl sebacate is a skin sensitiser from its chemical
structure - GLP compliance:
- no
- Remarks:
- Not required
- Key result
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- QSAR produced qualitative result
- Interpretation of results:
- other: Negative
- Remarks:
- Criteria used for interpretation of results: other: QSAR method
- Conclusions:
- Diisodecyl sebacate was not predicted to be a skin sensitiser by the Danish EPA DB, used via the OECD QSAR Toolbox (v.3.0).
- Executive summary:
The potential for diisodecyl sebacate (DIDS) to act as a skin sensitiser was assessed using the Danish EPA DB, via the OECD QSAR Toolbox (v.3.0) (OECD, 2012).
From its structure, DIDS was not expected to be a skin sensitiser.
The REACH guidance suggests that QSAR results may be considered for this endpoint as part of an integrated testing strategy (ECHA, 2012a).
Reference
No
explicit domain available. Predictions and domain results are
pre-calculated and stored in database.
In domain.
In an MC4PC five-fold 2 * 50 % cross-validation performed on this model by DK National Food Institute:
Sensitivity was 69.9%
Specificity was 95.4%
Concordance was 90.7%
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No relevant data on the potential for DIDS to cause skin sensitisation were identified in humans or laboratory animals.
DIDS was predicted not to be a skin sensitiser from its structure using the Danish EPA DB model via the OECD QSAR Toolbox (v.3.0). Additionally, no structural alerts for protein binding were identified (by OASIS v.1.1 or OECD) (OECD, 2012).
Relevant read-across data:
A lack of strong skin sensitising potential was seen for DIDA in a pre-GLP study similar to guideline studies. Four guinea pigs given three daily undiluted applications exhibited no reactions indicative of sensitisation when challenged four days later (Conning, 1970).
Reactions indicative of sensitisation were not seen in a limited skin sensitisation study on a group of two to four rabbits treated with undiluted DOS once, then 2-wk later [this study is considered limited due to the single induction application and the small number of animals tested]. In humans, DOS produced no reactions indicative of sensitisation when applied neat to the skin of 15-30 subjects for 48 hr, then again 2 wk later [again, this study is limited as only a single induction application] (Mallette and Von Haam, 1952a,b).
References
Mallette FS and von Haam E (1952). Studies on the toxicity and skin effects of compounds used in the rubber and plastics industries. I. Accelerators, activators, and antioxidants. AMA Archives of Industrial Hygiene and Occupational Medicine 5, 311-317.
Mallette FS and von Haam E (1952b). Studies on the toxicity and skin effects of compounds used in the rubber and plastics industries. II. Plasticizers. AMA Archives of Industrial Hygiene and Occupational Medicine 6, 231-236.
Migrated from Short description of key information:
No relevant data on the potential for DIDS to cause skin sensitisation were identified in humans or laboratory animals. No skin sensitising potential was predicted for DIDS in the OECD Toolbox (OECD, 2012) and a lack of strong skin sensitising potential was seen for DIDA in a limited guinea pig maximisation test (Conning, 1970). Limited in vivo studies on DOS (including in human subjects) also suggest a lack of skin sensitising potential.
Justification for selection of skin sensitisation endpoint:
No test data available on DIDS, but reliable predictions.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No relevant data on the potential for DIDS to cause respiratory sensitisation were identified in humans or laboratory animals. However, DIDS is not expected to be a respiratory sensitiser based on its lack of skin sensitising potential. In addition, DIDS is unlikely to vaporise due to its low volatility and high boiling point, limiting the possibility for respiratory exposure during normal conditions of use.
The lack of skin sensitisation potential predicted for DIDS, and seen in a limited guinea pig maximisation study with DIDA, along with their low volatility suggests that such effects are unlikely to occur.
Migrated from Short description of key information:
No relevant data on the potential for DIDS to cause respiratory sensitisation were identified in humans or laboratory animals. The lack of skin sensitisation potential predicted for DIDS, and seen in a limited guinea pig maximisation study with DIDA, along with their low volatility suggests that such effects are unlikely to occur.
Justification for classification or non-classification
DIDS was predicted not to be a sensitiser in the QSAR analysis, and limited in vivo studies with DIDA and DOS indicate that these closely-related substances lack strong sensitising potential. On this basis, DIDS does not warrant classification as a skin or respiratory sensitiser according to the EU CLP or DSD criteria.
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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