Registration Dossier
Registration Dossier
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EC number: 268-761-3 | CAS number: 68139-30-0
Endpoint summary
Administrative data
Description of key information
In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA), OECD 442C.
The method is not applicable for the testing of substances of unknown or variable composition, complex reaction products or biological materials (UVCB substances) due to the unknown and/or variable composition of the test substance as the defined molar ratio of test chemical and peptide is needed for the assessment of the test results. 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts is a UVCB, therefore this test was not performed.
In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method (KeratinoSensTM), OECD 442D.
A GLP compliant OECD 442D test was performed on 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts to assess its skin sensitisation potential. This study concluded the substance is not a skin sensitiser.
In Vitro Skin Sensitisation: Human Cell Line Activation Test (h-CLAT), OECD 442E.
Substances with Log Kow up to 3.5 can be tested whereas substances with Log Kow higher than 3.5 tend to produce negative results. For such substances positive results could be used to support the identification of a test chemical as sensitiser. Negative results should be considered as inconclusive.
A GLP compliant OECD 442E test was performed, yeilding positive results to support classification of 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts as a potential skin sensitiser.
In Vivo Skin Sensitisation: Guinea pig maximisation test, OECD 406 - read-across to REWOTERIC® AM CAS.
A GLP compliant in vivo study was available on a read-across substance, 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C8-18(even numbered) acyl) derivs., hydroxides, inner salts. No skin reaction or sign of sensitisation was observed 24 and 48 hours after the challenges to any animal (control or treated groups).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08/02/2018 - 06/04/2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Deviations:
- no
- Remarks:
- see principles of method below for full details
- Principles of method if other than guideline:
- Deviations from the guidelines:
- The standard states MTT must be used for an incubation period of 4 hours, solubilised overnight in 10% SDS and read at 690 nm. The study uses MTT for a 3 hr incubation period, which is solubilised in isopropanol and read at 570 nm.
- The standard states that cinnamic aldehyde must be used at 4 - 64 μM, whereas the study uses cinnamic aldehyde 8 - 128 μM.
Neither deviations are considered to affect the validity of the study. - GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
- Justification for non-LLNA method:
- The test (KeratinoSens) test is a method for which validation studies have been completed followed by an independent peer review conducted by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) and is considered scientifically valid when used as part of an integrated approach to testing to determine skin sensitisers and non-sensitisers for the purposes of hazard classification and labelling.
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: DSP-001
- Expiration date of the lot/batch: 15th August 2018
- Purity test date: N/A
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Assumed to be stable
- Stability under test conditions:Assumed to be stable
- Solubility and stability of the test substance in the solvent/vehicle: Assumed to be stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Assumed to be stable - Details on the study design:
- Skin sensitisation (In vitro test system) - Details on study design:
Using a test system (KeratinoSens cell line derived from the HaCaT human keratinocytes) a luciferase reporter gene transcriptionally controlled by the Anti-oxidant Response Element from a gene that is known to be up regulated in contact with sensitisers was quantitatively measured.
Experiments were performed in plates where cells were exposed in individual concentrations to the test substance and appropriate control substances.
Solubility of the test item in cell culture medium was confirmed up to 200 mg/ml. Subsequent dilution in cell culture medium with 1% ethanol yielded a top concentration of 400 µg/ml. - Positive control results:
- The positive control, Cinnamic aldehyde, showed that there was a dose-dependent increase of induction =>1.5-fold in at least one concentration (at both 64 and 129 μM) and the CV% of blank values was < 20%, therefore the results are considered as valid.
- Key result
- Run / experiment:
- other: Test Item
- Parameter:
- other: EC1.5
- Value:
- 1.5
- Vehicle controls validity:
- not valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Run / experiment:
- other: Test item
- Parameter:
- other: Imax
- Value:
- 0.854
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Not specified.
- Acceptance criteria met for positive control: Pass.
- Acceptance criteria met for variability between replicate measurements: Not all criteria met, however results are considered valid.
- Range of historical values if different from the ones specified in the test guideline: No data. - Interpretation of results:
- other: borderline non-sensitiser
- Conclusions:
- 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts was classified as a borderline non-sensitiser based on the results of the OECD 442D in vitro skin sensitisation test.
- Executive summary:
The GLP-compliant study performed according to the OECD Test Guideline 442D, assessed the in vitro sensitisation potential of 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts using the test system (KeratinoSens test method).
The experiment uses the quantification of luciferase expression in the cell reporter line to determine the response to the test item, a negative control and a positive control, reporting the EC1.5 and Imax values.
After 48h exposure of cells with 12 concentrations of the test item, luciferase measurements and MTT viability testing were performed. The test item produced luciferase induction >1.5 in all 3 repetitions. The respective EC1.5 values were calculated as 16.48 µg/ml for repetition 1; 7.63 µg/ml for repetition 2 and 2.5 µg/ml for repetition 3. However, no dose response was observed in Rep1 and the viability was less than 70% in Rep 3 at the dose that elicited the induction above the threshold.
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23/01/2018 - 22/03/2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 442E (In Vitro Skin Sensitisation: human Cell Line Activation Test (h-CLAT)).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: THP-1 cell surface marker expression
- Justification for non-LLNA method:
- The test method (h-CLAT) has been evaluated in a European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM)-lead validation study and subsequent independent peer review by the EURL ECVAM Scientific Advisory Committee (ESAC) and was considered scientifically valid to be used as part of an Integrated Approach to Testing and Assessment (IATA) to support the discrimination between skin sensitisers and non-sensitisers for the purpose of hazard classification and labelling.
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: DSP-001
- Expiration date of the lot/batch: 15th August 2018
- Purity test date: N/A - Details on the study design:
- Skin sensitisation (In vitro test system)
- Details on study design: THP-1 cells were pre-cultured for either 48 or 72 hrs. Following this, the cells were dosed with the test item over an 8 dose range and incubated for 24 ±0.5hrs. The cells were then washed and stained with propidium iodide which allows for discrimination of live/dead cells by flow cytometry. The dose of test item that yields 75% cell viability (CV75) was calculated and taken forward for the next stage of testing. This dose finding assay was carried out over two independent runs.
THP-1 cells were pre-cultured again for 48hrs. Once the CV75 was determined, a narrower dilution series based around the CV75 value was produced for the test item. This dilution range was used to dose the cells again for 24 ±0.5hrs. The cells were then washed and stained with propidium iodide and also with antibodies that detect CD54 and CD86 expression as well as a negative control antibody. This allowed for discrimination of live/dead cells and also changes in CD54 and CD86 marker expression by flow cytometry.
Prior to the CV75 determination, the test item was assessed for solubility and was found to be soluble in Isopropanol at 25 mg/mL. - Positive control results:
- Positive control - CV75:
Complete RPMI culture medium containing 10% Human Serum, 0.05mM 2-mercaptoethanol and 0.4% DMSO was used for reference to the positive control that was solubilised in DMSO. Positive control was accepted as both criteria where met (cell viability ≥ 75% at the lowest dose and the highest test item concentration produced cytotoxicity).
Positive Control - CD54 and CD86 Expression:
Complete RPMI culture medium containing 10% Human Serum, 0.05mM 2-mercaptoethanol and 0.4% Isopropanol was used for reference to the test item that was solubilised in Isopropanol. Positive control was accepted as all criteria where met. - Run / experiment:
- other: 1
- Parameter:
- other: CD54 RFI
- Value:
- 24
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: CD86 RFI
- Value:
- 69
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Run / experiment:
- other: 1
- Parameter:
- other: CD54 RFI
- Value:
- 65
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: CD86 RFI
- Value:
- 75
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The RFI values for CD54 and CD86 expression did not cross the sensitisation thresholds, therefore, 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts was classified as a non-sensitiser as per the prediction model.
- Executive summary:
The study assesses the in vitro sensitisation potential of 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts using the test system (h-CLAT test method). The study is GLP compliant performed according to the OECD Guideline 442E. The experiment uses the quantification of cytotoxic effects observed (CV75 assay) and cell surface marker expression on THP-1 cells (CD54 and CD86 assays) after 24-hour exposure to the test substance to determine the response. The relative fluorescence intensity (RFI) is used a measure of expression of CD54 and CD86, calculated from the results at test item doses in duplicate.
The expression of CD54, as measured by the RFI, did not cross the threshold (RFI ≥200) at any dose.
The expression of CD86, as measured by the RFI, did not cross the threshold (RFI ≥150) at any dose.
EC200 and EC150 values for CD54 and CD86 expression were not determined.
Cell viability did not fall below 50% at any of the test item concentrations and therefore the result is deemed to be valid.
Therefore, under the conditions of this test 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts is not considered a skin sensitiser.
- Endpoint:
- skin sensitisation: in chemico
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
- Justification for type of information:
- The Direct Peptide Reactivity Assay (DPRA) is not applicable for the testing of UVCB substances due to the unknown and/or variable composition as the defined molar ratio of test chemical and peptide is needed for the assessment of the test results. 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts is a UVCB, therefore this test was not performed.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Overall, the identities of the major known constituents the source and target substances are the same or very closely with the exception of minor variations in the C18 constituents.
Based on the similarities of the composition of the target substance and the analogue, they are expected to share similar properties in regards to their capacity to induce skin sensitisation.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
- Source: 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C8-18(even numbered) acyl) derivs., hydroxides, inner salts (EC 939-455-3)
- Target: 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts (EC 268-761-3)
3. ANALOGUE APPROACH JUSTIFICATION
The source and target substances share a very similar composition in regards to the C8-C18 constituents they contain.
1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts does not contain components above LOD known to induce skin sensitisation.
It can therefore be concluded that the source and target substances can be expected to share a similar potential to induce skin sensitisation, and that experimental data on the source substance can be used to fulfil the data requirements for the REACH Registration of the target substance for endpoints in accordance with Annex XI of REACH. - Reason / purpose for cross-reference:
- read-across source
- Specific details on test material used for the study:
- Commercial products covered by the composition:
- MACKAM CBS 50GE = aqueous solution at 36.3% w/w of active content (= surface-active fraction); aqueous solution at 49.5% w/w of solids (= REACH registered UVCB);
- MACKAM CBS 50G = aqueous solution at 42% w/w of active content (= surface-active fraction); aqueous solution at 50% w/w of solids (= REACH registered UVCB);
- REWOTERIC AM = aqueous solution at 42% w/w of active content (= surface-active fraction); aqueous solution at 50% w/w of solids (= REACH registered UVCB);
- REWOTERIC AM-CAS = aqueous solution at 42% w/w of active content (= surface-active fraction); aqueous solution at 50% w/w of solids (= REACH registered UVCB);
- BETADET SH-R = aqueous solution at 41.5% w/w of active content (= surface-active fraction). - 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:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0.
- 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:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- 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:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0.
- 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:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not sensitising
- Conclusions:
- Cocamidopropyl hydroxysultaine, as a 42% solution, is not considered a skin sensitiser.
- Executive summary:
Based on similarities in chemical composition, 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C8-18(even numbered) acyl) derivs., hydroxides, inner salts (EC 939-455-3) was identified as a suitable read-across substance to assess the capacity of the1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts to induce skin sensitisation.
In a Guinea-Pig Maximisation Test performed according to OECD Test Guideline 406, Cocamidopropyl hydroxysultaine as a 42% solution ( REWOTERIC® AM CAS) 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 no sign of sensitisation was observed 24 and 48 hours after the challenge in any animal (control or treated groups).
Based on these results, it is concluded that 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts does not meet the criteria for classification in accordance with CLP Regulation (EC) 1272/2008.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5 January, 1988 - 5 February, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP and OECD Guideline 406 compliant study. 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)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- In-vivo test method performed prior to REACH Regulation coming in to force (report dated 1998) and in-vitro methods not available.
- Specific details on test material used for the study:
- Commercial products covered by the composition:
- MACKAM CBS 50GE = aqueous solution at 36.3% w/w of active content (= surface-active fraction); aqueous solution at 49.5% w/w of solids (= REACH registered UVCB);
- MACKAM CBS 50G = aqueous solution at 42% w/w of active content (= surface-active fraction); aqueous solution at 50% w/w of solids (= REACH registered UVCB);
- REWOTERIC AM = aqueous solution at 42% w/w of active content (= surface-active fraction); aqueous solution at 50% w/w of solids (= REACH registered UVCB);
- REWOTERIC AM-CAS = aqueous solution at 42% w/w of active content (= surface-active fraction); aqueous solution at 50% w/w of solids (= REACH registered UVCB);
- BETADET SH-R = aqueous solution at 41.5% w/w of active content (= surface-active fraction). - Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- 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 1988TEST ANIMALS
- Source: Originally raised in Dunkin Harley, England. Build-up of an SPF phylum after hysterectomy at LAC (Laboratory Animal Centre, GB). Animals from there were
used for breeding by Hoechst Company, Frankfurt, after renewed hysterectomy. In 1976, the breeder received animals from Hoechst Company which were used for breeding subject to SPF conditions.
- Females (if applicable) nulliparous and non-pregnant: Yes.
- Microbiological status of animals, when known:
- Age at study initiation:
- Weight at study initiation: 229 - 284 grams.
- Housing: Maximum 5 guinea pigs per cage. Makrolon IV cgae, (height = 20 cm, width = 33 cm, length = 55 cm)
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: at least seven days.
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 deg. C +/- 2 deg. C.
- Humidity (%): 50-85 %.
- Air changes (per hr): No data.
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 07:00 to 19:00 h.
- IN-LIFE DATES: From: 29th December 1987 To: - Route:
- intradermal and epicutaneous
- Vehicle:
- other: deionised water
- Concentration / amount:
- - Induction: 10%
- Challenge: 100% - No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: deionised water
- No.:
- #2
- Concentration / amount:
- - Induction: 10%
- Challenge: 100% - No. of animals per dose:
- 20 test 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] + Deionised 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:
- 20 control animals
- Positive control substance(s):
- no
- 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:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0.
- 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:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- 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:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0.
- 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:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- other:
- Group:
- positive control
- Remarks on result:
- other: No positive controls used in this study
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not sensitising
- 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 Test Guideline 406, Cocamidopropyl hydroxysultaine as a 42% solution (REWOTERIC® AM CAS) 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 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 to be a skin sensitiser according to CLP Regulation (EC) 1272/2008.
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RANGE FINDING
No primary skin irritations were identified in the two guinea pigs treated.
BODYWEIGHTS (n=20)
Start: 229 - 284 grams
End: 327 - 479 grams
RANGE FINDING
No primary skin irritations were identified in the two guinea pigs treated.
BODYWEIGHTS (n=20)
Start: 229 - 284 grams
End: 327 - 479 grams
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
The skin sensitisation potential of 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts was assessed experimentally by two of the three available in vitro tests (OECD 442D and 442E). OECD 442C could not be performed as the substance is a UVCB. The results of OECD 442D were negative, whilst those of 442E were positive and therefore no overall conclusion on classification can be determined based on these two results alone.
A GLP compliant in vivo study was available on the read-across substance 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C8-18(even numbered) acyl) derivs., hydroxides, inner salts. No skin reaction or sign of sensitisation was observed 24 and 48 hours after the challenges to any animal (control or treated groups). Based on this result and other supporting evidence it was concluded that the substance not be considered a skin sensitiser.
Based on the results of the in vitro testing on this substance, results from a read-across substance and the historical use of Cocamidopropyl hydroxysultaine and similar substances in leave-on (~2.5% active ingredient) and rinse off (up to 11.5% active ingredient) cosmetic and personal care products, 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts is not considered to be a skin sensitiser according to CLP Regulation (EC) 1272/2008.
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