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EC number: 294-268-8 | CAS number: 91697-07-3
- 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
A Human repeated Insult Patch Test was performed with the registered substance (1% dilution). Under the conditions of this study, 1% dilution of the test material, did not indicate a clinically significant potential for dermal irritation or allergic contact sensitization.
Two modified Draize-Shelanski Repeat Insult Patch Tests were carried out to test for sensitisation with a read across substance (CAS 37294-89-8 or disodium C-isodecyl sulphonatosuccinate): one with a batch containing 90% active ingredient and one with 37% active ingredient. In both studies, there were no instances of irritation or sensitisation from this material on the Draize-Shelanski Test. It is unlikely that this material would present irritation or sensitisation in normal, intended use.
In summary, none of the tested sulfosuccinates showed skin sensitizing properties. The target substance is considered not to be sensitizing to the skin.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A Human repeated Insult Patch Test was performed with the registered substance (1% dilution). The test substance (1% dilution) was applied on the upper back of the volunteers using an occlusive dressing. Patches were applied 3 times per week for a total of nine applications. Following supervised removal and scoring of the first induction patch, participants were instructed to remove all subsequent Induction patches at home, 24 h after application. The evaluation of this site was made again just prior to reapplication. Approximately 2 weeks after the final induction patch application, a challenge patch was applied to a virgin test site adjacent to the original induction patch site. The patch was removed and the site scored at the clinic 24 and 72h post application.
Under the conditions of this study, 1% dilution of the test material, did not indicate a clinically significant potential for dermal irritation or allergic contact sensitization.
Sensitisation data with higher active ingredient concentration are not available for the registered substance, however read across data were available from a rea-across substance, CAS No. 37294 -49 -8 (Butanedioic acid, sulfo-, 1,4-diisodecyl ester, sodium salt).
Two modified Draize-Shelanski Repeat Insult Patch Tests were carried out to test for sensitisation:
- In the first study a batch with >90% active ingredient was used (key study: Kligman, 1976).
- In the second study a batch with 37% active ingredient was used (supportingn study; Kligman, 1977).
The study design was as follows: a 15 mm patch with 300 mg test material (2.5% test material) was applied to patch sites on the back or volar forearms of 100 subjects for ten alternate-day 24 hour period under occlusion. Following a seven-day rest period, 15 mm challenge patches (1% test material) of the material were applied in the same manner to fresh sites on the back or volar forearms of all 100 subjects for 24 hours. Challenge sites were read on removal of the patch and 24 hours thereafter, using the 0-4 scale. Therefore, it is unlikely that this material would present irritation or sensitisation in normal, intended use.
Conclusion
In all studies, there were no instances of irritation or sensitisation from this material on the Draize-Shelanski Test. It is unlikely that this material would present a danger of irritation or sensitisation in normal, intended use.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data from the registered substance and a read across substance, there was no indication for sensitisation from the Human Patch Test, classification for sensitisation is not warranted.
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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