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Diss Factsheets
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EC number: 941-224-7 | CAS number: -
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study non-GLP with limited data on study design, however the study was conducted to state of the art methods at that time period. The study is therefore considered adequate, reliable and relevant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Modified Draize-Shelanski Repeat Insult Patch Test
- GLP compliance:
- no
- Type of study:
- other: Modified Draize-Shelanski Repeat Insult Patch Test
- Justification for non-LLNA method:
- The study is based on standards at the time of conduct.
Test material
- Reference substance name:
- trisodium 1,4-dioxo-1,4-bis(pentyloxy)butane-2-sulfonate pentane-1-sulfonate pentane-2-sulfonate
- EC Number:
- 941-224-7
- Molecular formula:
- C14H25O7S.Na
- IUPAC Name:
- trisodium 1,4-dioxo-1,4-bis(pentyloxy)butane-2-sulfonate pentane-1-sulfonate pentane-2-sulfonate
- Test material form:
- other: waxy solid
- Details on test material:
- - Name of test material (as cited in study report):AEROSOL ® AY; Sodium Diamyl Sulfosuccinate
- Physical state: Waxy solid
- Analytical purity: >97 %
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Isomers composition: Not provided
- Purity test date: Not provided
- Lot/batch No.: S-11700-88-B (product code 24906-01)
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Not applicable
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 2.5% AEROSOL ® AY in petrolatum (Induction)
1% AEROSOL ® AY in petrolatum (Challenge)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 2.5% AEROSOL ® AY in petrolatum (Induction)
1% AEROSOL ® AY in petrolatum (Challenge)
- No. of animals per dose:
- 100
- Details on study design:
- Modified Draize-Shelanski Repeat Insult Patch Test: Aproximately 300 mg of the 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, challenge patches 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.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5% Aerosol AY in petrolatum (induction); 1% Aerosol AY in petrolatum (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 100
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5% Aerosol AY in petrolatum (induction); 1% Aerosol AY in petrolatum (challenge). No with. + reactions: 0.0. Total no. in groups: 100.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5% Aerosol AY in petrolatum (induction); 1% Aerosol AY in petrolatum (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 100
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5% Aerosol AY in petrolatum (induction); 1% Aerosol AY in petrolatum (challenge). No with. + reactions: 0.0. Total no. in groups: 100.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- There were no instances of irritation or sensitization from this test item on the Draize-Shelanski Test.
It is unlikely that this test item would present a danger of irritation or sensitization in normal, intended use. - Executive summary:
In a Modified Draize-Shelanski Repeat Insult Patch Test aproximately 300 mg of the test item containing > 97% active ingredient (2.5% in petrolatum) 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, challenge patches of the test item (1% in petrolatum) 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. There were no instances of irritation of sensitization from this material on the Draize-Shelanski Test. It is unlikely that this material would present a danger of irritation or sensitization in normal, intended use.
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