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EC number: 293-878-1 | CAS number: 91648-19-0
- 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 Guinea-Pig Maximisation Test performed according to OECD 406 test guideline with Cocamidopropyl hydroxysultaine as a 42% solution is available which shows the substance is not a skin sensitisier.
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:
- January to February 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP and OECD 406-compliant study, but no dose-range finding procedure is described and no positive control test substance was included whereas the 100% concentration tested was not irritant. In addition, no test substance batch number was reported.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The skin sensitisation study was conducted prior to the LLNA being the study type of choice.
- Specific details on test material used for the study:
- Appearance: Light yellow clear, slightly viscous liquid
Storage: Room temperature - Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Extertal
- Weight at study initiation: 229-284 g
- Housing: maximum of 5 animals per cage
- Caging: Makrolon type IV cage (20 x 33 x 55 cm)
- Diet: ad libitum
- Water: ad libitum
- Acclimitisation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20
- Humidity (%): 50-85
- Photoperiod: 12 hours light/dark cycle
IN-LIFE DATES: From: 5 January 1988 To: 5 February 1988 - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Remarks:
- deionised
- Concentration / amount:
- 10% for intradermal induction
100% for topical induction - Day(s)/duration:
- Topical induction 7 days after intradermal induction; 48 hour topical induction
- Adequacy of induction:
- highest technically applicable concentration used
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%/0.5 mL
- Day(s)/duration:
- 24 hour exposure
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Twenty
- Details on study design:
- RANGE FINDING TESTS: Two Guinea-pigs received a dermal application of the test item at 100% (0.5 mL per animal) under occlusive conditions.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal + topical)
- Exposure period: One week
- Test groups: One test group receiving test solution at 10% in deionised water, 10% in Freund's Complete Adjuvant (FCA) and undiluted FCA (0.05 mL per injection) [intradermal] + Undiluted test solution (0.5 mL) [topical]
- Control group: One control group receiving undiluted FCA, deionised water 10% in FCA and undiluted deionised water (0.05 mL per injection) [intradermal] + Deionized water (0.5 mL) [topical]
- Site: 2 injections sites arranged in pairs bilaterally to spinal column
- Frequency of applications: Topical induction 7 days after intradermal one
- Duration: Acute (intradermal) / 48 h (topical)
- Concentrations: 10% (intradermal) / 100% (topical)
B. CHALLENGE EXPOSURE
- No. of exposures: 1 occlusive patch
- Day(s) of challenge: 3 weeks following intradermal induction
- Exposure period: 24 hours
- Test groups: Undiluted test solution (0.5 mL)
- Control group: Undiluted deionised water (0.5 mL)
- Site: Same as intradermal injection sites
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 hours after patch removal - Challenge controls:
- Water was used as the vehicle control
- Positive control substance(s):
- no
- Positive control results:
- Not applicable.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 - water only
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 -water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Cocamidopropyl hydroxysultaine, as a 42% solution, is not considered a skin sensitiser.
- Executive summary:
In a Guinea-Pig Maximisation Test performed according to OECD No. 406 test guideline, Cocamidopropyl hydroxysultaine as a 42% solution was tested for its skin sensitising potential in Pirbright guinea pigs. A preliminary test on two animals using the test solution at 100% showed that this concentration was appropriate for topical application. For the main test, 20 animals were applied the vehicle (deionised water) only (control group) and 20 other animals were applied the test substance. For the induction phase, animals received an intradermal injection of the test substance at 10% in deionised water or in Freund’s Complete Adjuvant (FCA) emulsion. One week later, a second induction was performed by a topical application of the test solution at 100%. Two weeks after the topical induction phase, challenge was performed by applying the test substance at 100% topically under occlusive conditions for 24 hours. Observation and grading of skin reactions was performed 24 and 48 hours after patch removal to assess potential sensitisation. No skin reaction and therefore no sign of sensitisation was observed 24 and 48 hours after the challenge in any animal (control or treated groups). Therefore, under the conditions of this test, Cocamidopropyl hydroxysultaine as a 42% solution is not considered as a skin sensitiser according to the criteria of Regulation (EC) 1272/2008 (CLP).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In a Guinea-Pig Maximisation Test performed according to OECD 406 test guideline, Cocamidopropyl hydroxysultaine tested as a 42% solution showed no skin reaction and therefore no sign of sensitisation when assessed 24 and 48 hours after a challenge in any animal (control or treated groups). Therefore, under the conditions of this test, Cocamidopropyl hydroxysultaine as a 42% solution is not considered as a skin sensitiser according to the criteria of Regulation (EC) 1272/2008 (CLP).
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