Registration Dossier
Registration Dossier
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EC number: 242-893-1 | CAS number: 19223-55-3
Endpoint summary
Administrative data
Description of key information
When tested for skin irritation in vivo, the structural analogue Cocamidopropyl hydroxysultaine as a 41.5% solution, was not irritating. By analogy, the registered substance Lauramidopropylhydroxysultaine is considered not irritating to skin.
When tested for eye irritation in vivo at concentrations of 41.5%, the analogue Cocamidopropyl hydroxysultaine induced ocular damage that was persistent at the end of the observation period (7 to 21 days) in some animals. Cocamidopropyl hydroxysultaine is therefore considered a severe eye irritant. Furthermore, an in vitro test on chorioallantoic membrane of Hen's egg performed on the commercial product containing the registered substance at ca. 42% (commercial product diluted at 1.25% in the in vitro test) confirmed the severe eye irritating potential of the registered substance.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 May 1995 - 27 July 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: accredited supplier
- Gender: male
- Age upon arrival at test facility: approx. 9-10 weeks
- Weight at study initiation: 2.3 - 2.4 kg
- Housing: individually in stainless steel cages (48 x 59 x 37 cm) with grilled floor
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 50-85
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 30 May 1995 To: 16 June 1995 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after the end of exposure period (examinations at 60 min, 24, 48 and 72 h)
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: substance placed on 2.5 x 2.5 cm surgical gauze, patch held close to the skin using adhesive tape strips, strip of gauze wrapped around trunk of the animal using additional adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): once patch removed, remainder of product eliminated with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scale - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- See table below
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Cocamidopropyl hydroxysultaine, as a 41.5% solution, is not considered a skin irritant.
- Executive summary:
Cocamidopropyl hydroxysultaine, as a 41.5% solution, has been tested for acute skin irritation on 3 male New Zealand White rabbits, in accordance with OECD test guideline 404, and in compliance with Good Laboratory Practice.
The test article was applied as such in a single dermal dose of 0.5 mL to a shaved 6 cm² area of the intact skin, for 4 hours under a semi-occlusive dressing. Cutaneous examinations were performed at 1, 24, 48 and 72 hours after the dressing removal.
One hour after dressing removal, very slight erythema (grade 1) was observed in all animals. At examinations carried out 24 and 48 h after dressing removal, only one animal showed very slight erythema (grade 1).
No cutaneous reactions were observed in any of the animals at 72 hours after dressing removal.
Mean scores for erythema and edema (24, 48 and 72 hours after treatment) were 0.22 and 0.00, respectively.
Based on these results, Cocamidopropyl hydroxysultaine, as a 41.5% solution, was not considered a skin irritant.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
C8-C18 AAPHS and C12 AAPHS have the same functional groups, and general composition. The main variable resides in the alkyl chain distribution.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source chemical = C8-18 cocamidopropyl hydroxysultaine (EC 939-455-3)
Target chemical = C12 cocamidopropyl hydroxysultaine (EC 242-893-1)
3. ANALOGUE APPROACH JUSTIFICATION
The alkyl C-chain distribution of the source chemical significantly overlaps with the one of the target chemical, the C12-alkyl derivative being the major constituent in both chemicals. The structural differences in side C-chains is not expected to lead to significant differences on phys-chem properties.
4. DATA MATRIX: see "Documentation and scientific justification of the read-across approach" in section 13.2 - Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- C8-18 Cocamidopropyl hydroxysultaine, as a 41.5% solution, is not considered a skin irritant. By analogy, C12-18 Cocamidopropyl hydroxysultaine is not considered a skin irritant.
Referenceopen allclose all
Animal number |
Erythema / Eschar |
Edema |
||||||||
60 min |
24 h |
48 h |
72 h |
Individual score* |
60 min |
24 h |
48 h |
72 h |
Individual score* |
|
146 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
912 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
913 |
1 |
1 |
1 |
0 |
0.67 |
0 |
0 |
0 |
0 |
0 |
|
Mean score |
0.22 |
Mean score |
0 |
||||||
* For the 24, 48 and 72 h timepoints
Details of skin irritation scores (according to Draize)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- From 04 DEcember 2008 to 05 January 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented meeting accepted scientific principles, acceptable for assessment.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Hen's Egg Test - Utilizing the Chorioallantoic Membrane (HET-CAM). The test is a modification of that described by Kemper and Luepke (Kemper, F.M. & Luepke, N.P., (1986). The HET-CAM Test: An Alternative to the Draize Test. FD Chem. Toxic. 24, p. 495 - 496.).
The chick embryo has been used extensively in toxicology. The chorioallantoic membrane (CAM) of the chick embryo is a complete tissue with organoid elements from all germ cell layers. The chorionic epithelium is ectodermal and the allantoic epithelium is endodermal. The mesoderm located between these epithelia is a complete connective tissue including arteries, capillaries, veins and lymphatic vessels. The CAM responds to injury with a complete inflammatory reaction, comparable to that induced in the rabbit eye test. It is technically easy to study, and is without nerves to sense pain. - GLP compliance:
- no
- Species:
- other: White Leghorn eggs
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Moyer's Chicks, Inc., in Quakertown, Pennsylvania, USA
- Age at study initiation: up to 7 days (stored at 13°C +/- 3°C)
- Weight at study initiation: not applicable
- Housing: For incubation the eggs were placed, on their sides, in a Kuhl, humidified incubator. The incubator is such that the eggs are automatically rotated once every hour. The eggs were incubated for 10 days. On day eight (8) the eggs were turned so that the acutely angled end faced down.
- Diet (e.g. ad libitum): not applicable
- Water (e.g. ad libitum): not applicable
- Acclimation period: not applicable
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37° C (+/- 2° C)
- Humidity (%): not applicable
- Air changes (per hr): not applicable
- Photoperiod (hrs dark / hrs light): not applicable
IN-LIFE DATES: From: To: not applicable - Vehicle:
- not specified
- Controls:
- other: reference articles: Johnson's Baby Shampoo (diluted at 50%) and Head & Shoulders Shampoo (diluted at 50%)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.3 mL
- Concentration (if solution): 1.25% - Duration of treatment / exposure:
- 20 seconds
- Observation period (in vivo):
- All CAM's were observed immediately prior to test article administration and at 30 seconds, two and five minutes after exposure to the test article.
- Number of animals or in vitro replicates:
- 4 CAMs were used for each conditions (test item, reference articles)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test or reference article was rinsed from each CAM with 5 mL of physiological saline.
- Time after start of exposure: immediately after the end of the 20 seconds exposure period.
SCORING SYSTEM: The reactions of the CAM, the blood vessels, including the capillaries, and the albumin were examined and scored for irritant effects as detailed in the table 7.3.2/1. The numerical, time dependent scores were totaled for each CAM. Each reaction type can be recorded only once for each CAM, therefore the maximum score per CAM is 32. The mean score was determined for all CAM's similarly tested. Each article was then classified as indicated in the table 7.3.2/2.
TOOL USED TO ASSESS SCORE: no data - Irritation parameter:
- other: Average CAM score
- Value:
- 12
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- other: see details in Table 7.3.2/3
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Under the test conditions, the test item Mackam LSB-50 diluted at 1.25% (vehicle unknown) induced moderate irritating effects on the chorioallantoic membrane of Hen's Egg.
- Executive summary:
In an in vitro test on Chorioallantoic Membrane of Hen's Egg (HET-CAM test), 0.3 mL of Mackam LSB-50 diluted at 1.25% (vehicle unknown) was applied for 20 seconds on 4 Chorioallantoic Membranes from White Leghorn Hen’s egg. At the end of the exposure period, membranes were washed with physiological saline and observation of the membrane was done at 30 seconds, 2 and 5 minutes after the end of exposure. Different parameters such as Hyperemia, minimal hemorrhage (“feathering”), hemorrhage (obvious leakage) and coagulation and/or thrombosis were assessed and scored for each CAM at each time observation point. The mean score was determined for all CAM's similarly tested.
Two reference articles were also tested: Johnson's Baby Shampoo and Head & Shoulders Shampoo, both diluted at 50%.
The mean score for the CAM exposed to the test item Mackam LSB-50 diluted at 1.25% was 12.00 (max achievable score of 32.00). The mean score obtained for the CAM treated with the reference article Jonhson's baby shampoo at 50% was 11.00 (considered as moderate irritant) whereas the one obtained for the second reference article Head & Shoulders shampoo at 50% was 21.00 (considered as severe irritant).
Under the test conditions, the test item Mackam LSB-50 diluted at 1.25% induced moderate irritating effects on the chorioallantoic membrane of Hen's Egg. It can be assumed that the undiluted test item Mackam LSB-50 (containing the registered substance at ca. 42%) would induce more severe irritating effects. Therefore the classification as severe irritating to eyes (Eye Dam. 1, H318) of the registered substance, pure lauramidopropylhydroxysultaine, is warranted.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 May 1995 - 28 July 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: B&K Universal G.J., Barcelona, Spain
- Gender: male
- Age upon arrival at test facility: approx. 9-10 weeks
- Weight at study initiation: 2.2 - 2.4 kg
- Housing: individually in stainless steel cages (48 x 59 x 37 cm) with grilled floor
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 50-85
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 30 May 1995 To: 27 June 1995 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- ADMINISTRATION OF TEST SUBSTANCE
- Location: into the right conjunctival sac, made accessible by carefully pulling lower lid down
- Procedure immediately after instillation: lids of treated eye held closed for approx. 10 sec
OBSERVATION TIMEPOINTS: 1, 24, 48, 72 hours, and on day 7, 14 and 21 after instillation
SCORING SYSTEM: Draize scoring on conjunctivae, iris and cornea (as per OECD test guideline 405 recommendations)
TOOL USED TO ASSESS SCORE:
- Use of hand-slit lamp / biomicroscope: not specified
- Use of fluorescein: for all observations except 1 h after instillation - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21
- Remarks on result:
- probability of severe irritation
- Irritant / corrosive response data:
- See table below
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Cocamidopropyl hydroxysultaine, as a 41.5% solution, is considered a severe eye irritant.
- Executive summary:
Cocamidopropyl hydroxysultaine, as a 41.5% solution (Betadet SHR), has been tested for acute eye irritation on 3 male New Zealand White rabbits, in accordance with OECD test guideline 405, and in compliance with Good Laboratory Practice.
The test article was applied as such in a single conjunctival dose of 0.1 mL in the right eye of each rabbit, the untreated eye being used as a control. Ocular examinations, grading cornea, iris and conjunctiva (redness and chemosis) reactions, were performed at 1, 24, 48, 72 hours, and on day 7, 14 and 21 after instillation of the test article.
Within the first hour following instillation, the test article induced conjunctival abnormalities including hyperhaemia ranging from grade 2 (diffuse, crimson color, individual vessels not easily discernible) to grade 3 (diffuse, deep red color), edema ranging from grade 2 to 3, redness of the bulbar conjunctivae, lacrimation and congestion and injection of the iris (grade 1).
At the observations carried out 24, 48 and 72 hours after instillation, all rabbits showed hyperhaemia ranging from grade 2 to grade 3, chemosis from grade 1 to grade 3, redness of the bulbar conjunctivae, lacrimation and congestion and injection of the iris (grade 1). Corneal opacity (grade 1) was also observed in all animals.
Some of the corneal and conjunctival abnormalities persisted up to day 14 after instillation inclusive. Conjunctival chemosis was still observed in one of the rabbits 21 days after instillation of the test article.
Based on these results, Cocamidopropyl hydroxysultaine, as a 41.5% solution, was considered a severe eye irritant.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
C8-C18 AAPHS and C12 AAPHS have the same functional groups, and general composition. The main variable resides in the alkyl chain distribution.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source chemical = C8-18 cocamidopropyl hydroxysultaine (EC 939-455-3)
Target chemical = C12 cocamidopropyl hydroxysultaine (EC 242-893-1)
3. ANALOGUE APPROACH JUSTIFICATION
The alkyl C-chain distribution of the source chemical significantly overlaps with the one of the target chemical, the C12-alkyl derivative being the major constituent in both chemicals. The structural differences in side C-chains is not expected to lead to significant differences on phys-chem properties.
4. DATA MATRIX: see "Documentation and scientific justification of the read-across approach" in section 13.2 - Reason / purpose for cross-reference:
- read-across source
- Number of animals or in vitro replicates:
- 3 males
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21
- Remarks on result:
- probability of severe irritation
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Based on conjunctival chemosis still observed in one rabbit 21 days after instillation
- Conclusions:
- C8-18 Cocamidopropyl hydroxysultaine, as a 41.5% solution, is considered a severe eye irritant. By analogy, C12-18 Cocamidopropyl hydroxysultaine is considered as a severe eye irritant.
Referenceopen allclose all
Table 7.3.2/3: Results of the HET-CAM test
Substance |
CAM # |
Scores |
|
|
|
0.5 min |
2 min |
5 min |
Total |
||
Mackam LSB-50 (1.25%) |
1 |
5 7 |
0 |
0 |
12 |
2 |
5 7 |
0 |
0 |
12 |
|
3 |
5 7 |
0 |
0 |
12 |
|
4 |
5 7 |
0 |
0 |
12 |
|
Average |
12.00 |
||||
Reference article Johnson's Baby shampoo (50%) |
1 |
5 7 |
0 |
0 |
12 |
2 |
5 7 |
0 |
0 |
12 |
|
3 |
0 |
3 5 |
0 |
8 |
|
4 |
5 7 |
0 |
0 |
12 |
|
Average |
11.00 |
||||
Reference article Head & Shoulders shampoo (50%) |
1 |
5 7 |
0 |
5 7 |
24 |
2 |
5 7 |
0 |
5 7 |
24 |
|
3 |
5 7 |
7 |
0 |
19 |
|
4 |
5 7 |
0 |
5 |
17 |
|
Average |
21.00 |
||||
Animal number |
1 h |
24 h |
48 h |
72 h |
7 d |
14 d |
21 d |
Individual score* |
Cornea |
||||||||
299 |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
289 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
1 |
190 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
1 |
|
Mean score |
1 |
||||||
Iris |
||||||||
299 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
289 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
190 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
1 |
|
Mean score |
1 |
||||||
Conjunctival redness |
||||||||
299 |
3 |
3 |
3 |
2 |
1 |
0 |
0 |
2.67 |
289 |
2 |
3 |
3 |
3 |
2 |
1 |
0 |
3 |
190 |
2 |
3 |
3 |
2 |
1 |
1 |
0 |
2.67 |
|
Mean score |
2.78 |
||||||
Conjunctival chemosis |
||||||||
299 |
2 |
2 |
1 |
1 |
1 |
1 |
0 |
1.33 |
289 |
3 |
3 |
2 |
2 |
1 |
0 |
0 |
2.33 |
190 |
2 |
2 |
2 |
2 |
1 |
1 |
1 |
2 |
|
Mean score |
1.89 |
||||||
* For the 24, 48 and 72 h timepoints
Details of eye irritation scores (according to Draize)
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Only one RIPT test in human and one in vitro HET-CAM assay are available on the registered substance. In the absence of studies conducted according to OECD guidelines, a read-across was therefore performed with the cocamidopropyl hydroxysultaine which contains alkylamidopropylhydroxysultaine with carbon chain from C8 to C18. The main component of Cocamidopropylhydroxysultaine C8-18 is lauramidopropylhydroxysultaine. Justification for the read-across is documented in a separate document attached in Iuclid Section 13.
Skin irritation:
Cocamidopropyl hydroxysultaine was tested in vivo in a Klimisch score 2 study (1995), used as a key study. In this study, the test substance was applied to rabbits at 41.5% under semi-occlusive conditions for 4 hours. Very slight erythema was observed, which was fully reversible within 72 hours.
This correlates with the results of Repeated Insult Patch Tests in healthy human volunteers (see section 7.10.3. Direct observations), where the repeated dermal application of a 12% aqueous solution of Lauramidopropylhydroxysultaine to 54 healthy volunteers did not result in any skin reaction indicative of irritation.
Eye irritation:
Cocamidopropyl hydroxysultaine was tested in vivo in a Klimisch score 2 study (1995), used as a key study. In this study, the test substance was instillated at 41.5% in the eyes of rabbits observed for up to 21 days. Corneal and conjunctival injuries persisted for up to day 14 inclusive in some animals. Conjunctival chemosis was still observed in one of the rabbits 21 days after instillation.
An in vitro test on chorioallantoic membrane of Hen's egg was available on the registered substance itself and used as supporting study. In this test, a solution at 1.25% of the commercial product containing the registered substance induced moderate irritating effects of the membrane, confirming therefore that the pure registered substance is considered as severe eye irritant.
Justification for selection of skin irritation / corrosion
endpoint:
Recent GLP and OECD test guideline-compliant study (Klimisch score 2)
Justification for selection of eye irritation endpoint:
Recent GLP and OECD test guideline-compliant study (Klimisch score 2)
Effects on eye irritation: highly irritating
Justification for classification or non-classification
Skin irritation:
Based on the data available on Cocoamidoproplhydroxysultaine and Lauramidopropylhydroxysultaine, the registered substance does not need to be classified for skin irritation.
Eye irritation:
Based on the data available on Cocoamidoproplhydroxysultaine and Lauramidopropylhydroxysultaine, the registered substance
needs to be considered a severe eye irritant and classified accordingly as Eye damage 1, H318 (according to Reg. 1272/2008 (CLP) criteria).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
