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EC number: 604-617-1 | CAS number: 147993-66-6
- 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
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 test item on the Draize-Shelanski Test. It is unlikely that this test item would present a danger of irritation or sensitisation in normal, intended use.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test method is adequate and relevant, and was conducted according to standards at the time of conduct. The study is therefore considered adequate, relevant and reliable.
- Qualifier:
- according to guideline
- Guideline:
- other: Modified Draize-Shelanski Repeat Insult Patch Test
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- other: Modified Draize-Shelanski Repeat Insult Patch Test
- Justification for non-LLNA method:
- The study was conducted before the LLNA was proposed as standard assay.
- Species:
- human
- Strain:
- other: healthy adults
- Sex:
- male/female
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 2.5% Induction
1% Challenge - Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 2.5% Induction
1% Challenge - No. of animals per dose:
- 100
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 alternate-day 24 hour periods
- Exposure period: 1 day (24 hours)
- Test groups: 1 test group of 100 healthy humans
- Control group: no control group
- Site: patch sites on the back or volar forearms
- Frequency of applications: 10 applications
- Duration: 10 days
- Concentrations: 300mg of Aerosol® A-268 2.5% in petrolatum
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: After 7 days rest period
- Exposure period: 1 day (24 hours)
- Test groups: 1 test group of 100 healthy humans
- Control group: no control group
- Site: fresh patch sites on the back or volar forearms
- Concentrations: 300mg of Aerosol® A-268 1% in petrolatum
- Evaluation (hr after challenge): 24 and 48 hours - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 300mg
- No. with + reactions:
- 0
- Total no. in group:
- 100
- Clinical observations:
- 0
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 300mg . No with. + reactions: 0.0. Total no. in groups: 100.0. Clinical observations: 0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 300 mg
- No. with + reactions:
- 0
- Total no. in group:
- 100
- Clinical observations:
- 0
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 300 mg. No with. + reactions: 0.0. Total no. in groups: 100.0. Clinical observations: 0.
- Reading:
- other: 1st and 2nd reading
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Reading:
- other: 1st and 2nd reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- not sensitising
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- There were no instances of irritation or sensitisation from this test item on the Draize-Shelanski Test.
It is unlikely that thistest item would present a danger of irritation or sensitisation in normal, intended use. - Executive summary:
A modified Draize-Shelanski Repeat Insult Patch Test was conducted with a 15 mm patch with 300 mg test material (2.5% test material with 90% act. ingr.) 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 with 90% act. ingr.) 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. 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Sensitisation data were not available for the registered substance, however read across data were available from a category member, CAS No. 37294 -49 -8 (Disodium C-isodecyl sulphonatosuccinate).
Human patch testing:
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 (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.
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 a danger of irritation or sensitisation in normal, intended use.
Conclusion
- Based on negative outcome of skin potential in human Patch testing with read-acros substance, it is unlikely that the registered substance would present a danger of irritation or sensitisation in normal, intended use.
- This was further supported by negative data from human patch testing, as documented in the read-across justification (see Section 13).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data from read across, there was no indication for sensitisation from the Human Patch Test, classification for sensitisation is not warranted.
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