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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
Endpoint summary
Administrative data
Description of key information
A modified Draize-Shelanski Repeat Insult Patch Tests was carried out to test for sensitisation with the test item containing 97% active ingredient. There was no irritation or sensitisation from this material on the Draize-Shelanski Test.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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.
- 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.
- Species:
- human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Not applicable
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 2.5% AEROSOL ® AY in petrolatum (Induction)
1% AEROSOL ® AY in petrolatum (Challenge) - 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.
- 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
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A modified Draize-Shelanski Repeat Insult Patch Test (Kligman,1976) was carried out as a key test to investigate sensitization of the test item containing 97% active ingredient. The study design was as follows: aproximately 300 mg of the test item (2.5%) 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%) 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 or 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.
Further information supporting the absence of sensitisation potential is provided in the read across justification for the Diester category, showing that all substances in the group were negative for human patch testing on the human arm skin (justification with data matrix separately attached in Section 13).
Migrated from Short description of key information:
A modified Draize-Shelanski Repeat Insult Patch Test was carried out to test for sensitization with Aerosol AY (Introduction 2.5%, in petrolatum; challenge 1%, in petrolatum). There was no irritation or sensitization from this material. It is unlikely that this material would present a danger of irritation or sensitization in normal, intended use.
Justification for selection of skin sensitisation endpoint:
Key study
Justification for classification or non-classification
As there was no indication for sensitisation from the Human Patch Test with current substance and category analogues, classification for skin sensitisation is not needed according to CLP regulation (No. 1272/2008 of 16 December 2008).
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