Registration Dossier
Registration Dossier
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EC number: 939-457-4 | CAS number: 1469983-50-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January-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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- 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:
- At the time of the registration dossier constitution, the skin sensitization study had already been performed according to Magnusson & Kligman method (report dated 1988).
Test material
- Reference substance name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxooctyl)amino]propyl]ammonium hydroxide
- Molecular formula:
- C16H34N2O5S
- IUPAC Name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxooctyl)amino]propyl]ammonium hydroxide
- Reference substance name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxodecyl)amino]propyl]ammonium hydroxide
- Molecular formula:
- C18H38N2O5S
- IUPAC Name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxodecyl)amino]propyl]ammonium hydroxide
- Reference substance name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxododecyl)amino]propyl]ammonium hydroxide
- EC Number:
- 242-893-1
- EC Name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxododecyl)amino]propyl]ammonium hydroxide
- Cas Number:
- 19223-55-3
- Molecular formula:
- C20H42N2O5S
- IUPAC Name:
- N-[3-(dodecanoylamino)propyl]-2-hydroxy-N,N-dimethyl-3-sulfopropan-1-aminium hydroxide
- Reference substance name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxotetradecyl)amino]propyl]ammonium hydroxide
- Molecular formula:
- C22H46N2O5S
- IUPAC Name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxotetradecyl)amino]propyl]ammonium hydroxide
- Reference substance name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxohexadecyl)amino]propyl]ammonium hydroxide
- Molecular formula:
- C24H50N2O5S
- IUPAC Name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxohexadecyl)amino]propyl]ammonium hydroxide
- Reference substance name:
- [2-hydroxy-3-sulphopropyl]dimethyl[3-[(1-oxooctadecyl)amino]propyl]ammonium hydroxide
- EC Number:
- 264-390-6
- EC Name:
- [2-hydroxy-3-sulphopropyl]dimethyl[3-[(1-oxooctadecyl)amino]propyl]ammonium hydroxide
- Cas Number:
- 63663-12-7
- Molecular formula:
- C26H54N2O5S
- IUPAC Name:
- 2-hydroxy-N,N-dimethyl-N-[3-(stearoylamino)propyl]-3-sulfopropan-1-aminium hydroxide
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Water
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- ClNa
- IUPAC Name:
- sodium chloride
- Reference substance name:
- Glycerol
- EC Number:
- 200-289-5
- EC Name:
- Glycerol
- Cas Number:
- 56-81-5
- Molecular formula:
- C3H8O3
- IUPAC Name:
- glycerol
- Reference substance name:
- Disodium 2-hydroxypropane-1,3-disulfonate
- Molecular formula:
- C3H8O7S2.Na2
- IUPAC Name:
- Disodium 2-hydroxypropane-1,3-disulfonate
- Reference substance name:
- Sodium (±)-2,3-dihydroxypropanesulphonate
- EC Number:
- 252-542-4
- EC Name:
- Sodium (±)-2,3-dihydroxypropanesulphonate
- Cas Number:
- 35396-47-5
- Molecular formula:
- C3H8O5S.Na
- IUPAC Name:
- sodium (±)-2,3-dihydroxypropanesulphonate
- Reference substance name:
- Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl]
- EC Number:
- 930-947-3
- IUPAC Name:
- Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl]
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Extertal
- Age at study initiation: No data
- Weight at study initiation: 229-284 g
- Housing: max. 5 animals per Makrolon type IV cage (20 x 33 x 55 cm)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2
- Humidity (%): 50-85
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12 (7.00 am-7.00 pm)
IN-LIFE DATES: From: 5 January 1988 To: 5 February 1988
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: deionised water
- Concentration / amount:
- - Induction: 10%
- Challenge: 100%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: deionised water
- Concentration / amount:
- - Induction: 10%
- Challenge: 100%
- No. of animals per dose:
- 20 test + 20 control animals
- 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 - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- 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
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- 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
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- 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 Directive 67/548/EEC (DSD) or Regulation (EC) 1272/2008 (CLP).
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