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EC number: 405-740-1 | CAS number: 47073-92-7 AROCY L-10
- 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 vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP-compliant
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- ; see comments
- Principles of method if other than guideline:
- The substance could not be prepared in an injectable form (the test laboratory confirmed that a range of solvents were tried). Therefore for the first induction the substance was applied dermally over the site where adjuvant had been injected. Both topical induction stages involved wetting of the skin with aqueous sodium lauryl sulphate followed by a 48 hour application of the test substance under an occlusive dressing
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Darly Oaks, Newchurch, Burton-on-Trent, Staffordshire
- Age at study initiation: less than one year old
- Weight at study initiation: 370-447 g
- Housing: gang housing
- Diet: FDI Guinea Pig Diet, supplied by Special Diets Services (I Stepfield, Witham, Essex, CM8 3AD), supplemented with hay and allowed food
- Water (e.g. ad libitum): tap water
- Acclimatisation period: 7 days prior to test commencement
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 51%
- Photoperiod (hrs dark / hrs light): A 12 h light/dark cycle was in operation (light hours 0700-1900 h) - Route:
- other: The substance could not be prepared in an injectable form (the test laboratory confirmed that a range of solvents were tried). Therefore for the first induction the substance was applied dermally over the site where adjuvant had been injected. Both topica
- Vehicle:
- paraffin oil
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
- Topical: 25% v/v in paraffin oil
Concentration of test material and vehicle used for each challenge:
- 10% v/v in paraffin oil - Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
- Topical: 25% v/v in paraffin oil
Concentration of test material and vehicle used for each challenge:
- 10% v/v in paraffin oil - No. of animals per dose:
- - Number of animals in test group: 20
- Number of animals in negative control group: 20 - Details on study design:
- The substance could not be prepared in an injectable form (the test laboratory confirmed that a range of solvents were tried). Therefore for the first induction the substance was applied dermally over the site where adjuvant had been injected. Both topical induction stages involved wetting of the skin with aqueous sodium lauryl sulphate followed by a 48 hour application of the test substance under an occlusive dressing.
- Positive control substance(s):
- yes
- Remarks:
- Positive control substance: 2,4-dinitro-chlorobenzene (DNCB)
- Positive control results:
- Checked at 6 monthly intervals. The most recent positive control test with DNCB was completed on 16 December 1988 when 100% of the test group animals reacted positively.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item did not show a sensitization reaction in guinea pigs.
- Executive summary:
The skin sensitization test was performed on guinea pigs according to EU-testing method B.6. The substance could not be prepared in an injectable form (the test laboratory confirmed that a range of solvents were tried). Therefore for the first induction the substance was applied dermally over the site where adjuvant had been injected. Both topical induction stages involved wetting of the skin with aqueous sodium lauryl sulphate followed by a 48 hour application of the test substance under an occlusive dressing. Satisfactory skin responses were noted at induction. The substance is not classified as a skin sensitiser.
Reference
Dose Ranging Test for Induction:
Only slight reactions were noted at 2 sites treated topically with the test material at one concentration only, 25% v/v in paraffin oil. A concentration of 25% v/v in paraffin oil was selected for the topical application (phases 1 and 2) of induction in the test group.
Main Test - Induction:
Moderate irritation was noted in the test group after the first topical application, with slight reactions after the second application. The control groups reacted slightly after the first application only.
Dose Ranging Test for Challenge:
Slight reactions.were noted in both guinea pigs at a concentration of 25% v/v in paraffin oil. A concentration of 10% v/v in paraffin oil was selected for challenge.
Main Test - Challenge:
Following challenge with the test item at a concentration of 10% v/v, none of the 20 test group animals showed positive reactions to this application. None of the 20 control group animals, which had previously only been exposed to the vehicle, paraffin oil, showed a positive reaction to this application.
Body Weights:
Body weights were recorded at main test commencement and on test completion. Body weight gains were acceptable.
Clinical Signs:
No clinical signs, other than skin reactions induced by treatment, were noted.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
- Migrated from Short description of key information:
The skin sensitization test was performed on guinea pigs according to EU-testing method B.6. The substance could not be prepared in an injectable form (the test laboratory confirmed that a range of solvents were tried). Therefore for the first induction the substance was applied dermally over the site where adjuvant had been injected. Both topical induction stages involved wetting of the skin with aqueous sodium lauryl sulphate followed by a 48 hour application of the test substance under an occlusive dressing. Satisfactory skin responses were noted at induction. The substance is not classified as a skin sensitiser.
Justification for selection of skin sensitisation endpoint:
Reliable data from ELINCS-notification (Klimisch 1)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the data available the substance is not classified or labeled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP).
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