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EC number: 825-403-6 | CAS number: 2060541-51-5
- 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
One modified Bühler test on Sodium cocoamphopolycarboxyglycinate (Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts with CAS no 2060541-51-5) and one Guinnea pig maximization test on Sodium tallowamphopolycarboxyglycinate (Amines, N-[3-[(3-aminopro yl)amino]propyl]-N’-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-47-9) are available within the amphoteric, glycinate substance group. The results indicate lack of sensitisation, although the testing had not been performed with pure compounds, but the technical 40% aqueous solutions. However, if the pure freeze-dried substances were to be tested, testing of solids in LLNA generally results to about 50% concentrations, which is not far from the available data using 40%. Based on animal welfare grounds further testing at higher concentrations was therefore not proposed.
Profiling the amphoteric, glycinate substances for skin sensitizing properties using Derek Nexus, TOPKAT as well as the QSAR Toolbox indicates that no alerts are found for protein binding or structural alerts. The query structure does not contain any unclassified or misclassified features and is consequently predicted to be a non-sensitiser. There are no reports on incidences of sensitisation from industrial production and use of the substances. Taken all the available information together, read across using the available data is considered applicable within the substance group.
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:
- 10 May 1995 - 14 June 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was performed similar to OECD guidelines and under GLP. No data on substance identity (SURFACTANT HDC 94-05-20-03). Concentrations did not elicit required irritation levels
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Principles of method if other than guideline:
- The induction procedure was repeated for three weeks to give a total of nine 6-hour exposure instead of three 6 hour induction exposures.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The default animal study for skin sensitisation in the ECHA Guidelines, is the Local Lymph Node Assay (LLNA) OECD429. However it is accepted in the OECD guideline for the LLNA that it has some limitations, as follows: “Despite the advantages of the LLNA over TG 406, it should be recognised that there are certain limitations that may necessitate the use of TG 406 (13) (e.g. false negative findings in the LLNA with certain metals, false positive findings with certain skin irritants [such as some surfactant type chemicals] (19) (20), or solubility of the test substance)”. For the amphoteric glycinate substances, there are available in-vivo skin sensitizing studies performed before the LLNA was recommended as a standard. As these studies are considered to be of high reliability rating and the results are considered relevant, it is not justified from an animal well-fare perspective to perform any additional skin sensitising studies. For this reason the available guinea pig studies are provided as key studies.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: by David Hall
Limited, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 300-387 grams
- Housing: single or in pairs in solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minumum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 51-64
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 10 May 1995 - 14 June 1995 - Route:
- epicutaneous, occlusive
- Vehicle:
- other: unchnged or distilled water
- Concentration / amount:
- Topical Induction
Group 1 : undiluted as supplied
Group 2 : 25% v/v in distilled water
Topical Challenge : undiluted as supplied and 25% v/v in distilled water - Route:
- epicutaneous, occlusive
- Vehicle:
- other: unchnged or distilled water
- Concentration / amount:
- Topical Induction
Group 1 : undiluted as supplied
Group 2 : 25% v/v in distilled water
Topical Challenge : undiluted as supplied and 25% v/v in distilled water - No. of animals per dose:
- 20 test animals per group and 10 control animals
- Details on study design:
- RANGE FINDING TESTS:
Selection of Concentration for Topical Induction
Two previously untreated guinea pigs were treated with 0.5 ml of the undiluted test material and three concentrations of the test material in 80% aqueous ethanol (75%, 50%, and 25% v/v). Applications were made to the clipped flanks under occlusive dressings for an exposure period of 6 hours. The degree of erythema and oedema was evaluated 24 and 48 hours after dressing removal. The highest concentration of the test material producing
only mild dermal irritation was selected for the topical induction of Group 1 animals in the main study. A second concentration (25% v/v in distilled water) was selected by the study sponsor for induction of Group 2 animals.
Selection of Concentration for Topical Challenge
Two guinea pigs were treated with 0.5 ml of undiluted test material and one concentration of the test material in distilled water (75% v/v). These animals had been treated identically to the control animals of the main study on Days 0, 7 and 14. Applications were made to the clipped flanks under occlusive dressings for an exposure period of 6 hours. The degree of erythema and oedema was evaluated 24 and 48 hours after dressing removal. The highest concentration of the test material which produced no evidence of dermal irritation, was selected for the topical challenge stage of the main study. 25% v/v was selected by the study sponsor as the lower concentration for the topical challenge stage of the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
The hair was removed from an area on the left flank of each animal with veterinary clippers. A quantity of 0.5 ml of the undiluted test material was applied to the shorn left flank on an absorbent cotton lint patch (approximate size 15 mm x 35 mm). The patch was held in place under a strip of
surgical adhesive tape (BLENDERM: approximate size 50 mm x 60 mm) and covered with an overlapping length of aluminium foil. The patch and foil were further secured by a strip of elastic adhesive bandage (ELASTOPLAST: approximate size 70 mm x 250 mm) wound in a double layer around the torso of each animal.
- No. of exposures: 9
- Exposure period: 6 hours
- Test groups: 2x 20 animals
- Control group: 10 animals
- Site: left flank
- Frequency of applications: lnduction was performed on days 0; 2, 4, 7, 9, 1 1, 14, 16 and 18.
- Duration: 3 weeks
- Concentrations: 25% v/v in distilled water or unchanged as suppplied
lnduction of the Control Animals: The topical applications followed the same procedure as for the test animals except that the vehicle alone was applied.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28
- Exposure period: 6 hours
- Test groups: Shortly before treatment on Day 28, an area approximately 50 mm x 70 mm on the right shorn flank of each animal, was clipped free of hair with veterinary clippers. A quantity of 0.5 ml of the undiluted test material was applied to the shorn right flank of each animal on an absorbent cotton lint patch (approximate size 15 mm x 30 mm). The patch was held in place by a strip of surgical adhesive tape (BLENDERM: approximate size 40 mm x 50 mm). The test material at a concentration of 25% v/v in distilled water was similarly applied to a separate skin site on the right shorn flank. The patches were covered with an overlapping length of aluminium foil and further secured by a strip of elastic adhesive bandage (ELASTOPLAST: approximate size 70. mm x 250 mm) wound in a double layer around the torso.
- Control group: the same procedure as for the test animals
- Site: left flank
- Concentrations: 25% v/v in distilled water or unchanged as suppplied
- Evaluation (hr after challenge): Approximately 24 and 48 hours after dressing removal, the degree of erythema and oedema was quantified
OTHER: - - Challenge controls:
- The same procedure as for the test animals, see above.
- Positive control substance(s):
- not required
- Reading:
- other: all readings
- Group:
- other: all test groups
- Dose level:
- 25% or undiluted as supplied
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: other: all readings. Group: other: all test groups. Dose level: 25% or undiluted as supplied. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material, consisting of 40% active ingredient and 60% water, produced a 0% (0/20) sensitisation rate and was classified as a non-sensitiser to guinea pig skin under the conditions of the study. Therefore the active ingredient Sodium cocoamphopolycarboxyglycinate (Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts with CAS no 2060541-51-5) is considered to be non sensitising.
- Executive summary:
A study was performed to assess the contact sensitisation potential of the test material in the albino guinea pig. The study was performed in compliance with the OECD Guidelines for Testing of Chemicals No. 406 "Skin Sensitisation" B6 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). Two groups of twenty test animals and ten control animals were used for the main study. Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as follows: Topical Induction Group 1 : undiluted as supplied Group 2 : 25% v/v in distilled water Topical Challenge : undiluted as supplied and 25% v/v in distilled water. No effects were observed. The test material, consisting of 40% active ingredient and 60% water, produced a 0% (0/20) sensitisation rate and was classified as a non-sensitiser to guinea pig skin under the conditions of the study. Therefore the active ingredient Sodium cocoamphopolycarboxyglycinate (Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts with CAS no 2060541-51-5) is considered to be non sensitising.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- One modified Bühler test on Sodium cocoamphopolycarboxyglycinate (Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts with CAS no 2060541-51-5) and one Guinnea pig maximization test on Sodium tallowamphopolycarboxyglycinate (Amines, N-[3-[(3-aminopro yl)amino]propyl]-N’-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-47-9) are available within the amphoteric, glycinate substance group. The results indicate lack of sensitisation, although the testing had not been performed with pure compounds, but the technical 40% aqueous solutions. However, if the pure freeze-dried substances were to be tested, testing of solids in LLNA generally results to about 50% concentrations, which is not far from the available data using 40%. Based on animal welfare grounds further testing at higher concentrations was therefore not proposed.
Profiling the amphoteric, glycinate substances for skin sensitizing properties using Derek Nexus, TOPKAT as well as the QSAR Toolbox indicates that no alerts are found for protein binding or structural alerts. The query structure does not contain any unclassified or misclassified features and is consequently predicted to be a non-sensitiser. There are no reports on incidences of sensitisation from industrial production and use of the substances. Taken all the available information together, read across using the available data is considered applicable within the substance group. - Key result
- Reading:
- other: Challenge phase
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% test material (corresponds to 40% a.i)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Not described
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: Challenge phase
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% test material (corresponds to 40% a.i.)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Not described
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: Challenge phase
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% test material (corresponds to 20% a.i.)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Not described
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: Challenge phase
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% test material (corresponds to 20% a.i.)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Not described
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: Challenge phase
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Not described
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: Challenge phase
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Not described
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- On challenge with the test material, consisting of 40% active ingredient and 60% water, no visible response was exhibited by any animal in the test or control group when challenged with the undiluted test material and 50% aqueous concentration of the test material. From the results of this study there was no evidence to suggest that the active ingredient Sodium tallowamphopolycarboxyglycinate (Amines, N-[3-[(3-aminopro yl)amino]propyl]-N’-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-47-9) acts as a sensitiser in the guinea pig.
- Executive summary:
Accoring to methods similar to OECD 406 and under GLP ten guinea pigs were treated by intradermal injection in the shoulder region with the test material, Freund's Complete Adjuvant and a mixture of the test material and Freund's Complete Adjuvant. Seven days later this induction procedure was boosted by the topical application of the test material over the injection site. A second group of ten animals were similarly treated but distilled water was substituted for the test material. Two weeks after the induction phase all animals of both test and control groups were challenged with two concentrations of the test material applied topically to the flanks. On challenge with the test material no visible response was exhibited by any animal in the test or control group when challenged with the undiluted test material and 50% aqueous concentration of the test material. From the results of this study there was no evidence to suggest that the active ingredient of the test material, Sodium tallowamphopolycarboxyglycinate (Amines, N-[3-[(3-aminopro yl)amino]propyl]-N’-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-47-9) acts as a sensitiser in the guinea pig.
Referenceopen allclose all
Skin Reactions Observed After Topical lnduction
One animal was killed for humane reasons on day 13 due to respiratory problems, and one animal was found dead on day 16 (the cause of death was not investigated). The absence of these animals did not affect the purpose or integrity of the study.
Group 1 (Undiluted as Supplied)
Very slight to well defined erythema and very slight to slight oedema were elicited by the test material. Other skin reactions noted were desquamation, hardened light brown-coloured scab, hardened dark browdblack-coloured scab and small superficial scattered scabs. On occasions the skin reactions prevented the accurate evaluation of oedema and/or erythema. On occasions the test sites were changed due to severe reactions.
Group 2 (25% v/v in Distilled Water)
One test group animal was killed for humane reasons on day 13. One test group animal was found dead on day 16. The cause of death was not determined. The absence of these animals was considered not to affect the purpose or integrity of the study. Very slight erythema and very slight oedema were elicited by the test material. Other skin reactions noted were desquamation, hardened light brown-coloured scab and small superficial scattered scabs. On one occasion desquarnation prevented accurate evaluation of erythema in one test group animal. On occasions the test sites were changed due to severe reactions.
Vehicle Control
No skin reactions were noted at the vehicle control sites of control group animals following topical induction.
Skin Reactions Observed After Topical Challenge
No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48-hour observations.
Bodyweight Individual
Bodyweight gains of guinea pigs in the test group, between Day 0 and Day 30, were comparable to those observed in the control group animals over the same - period.
No reaction was observed in any of the animals exposed to the test substance or in the control group.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
There are no guidelines for an animal test for respiratory sensitization, however in general respiratory sensitizers are also skin sensitizers. Based on the available study on Sodium cocoamphopolycarboxyglycinate (Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts with CAS no 2060541-51-5), as well the read across data within the group of amphoteric, glycinate substance group the substance was not found to be a skin sensitizer. This indicates that the substance is unlikely to possess any significant potential for respiratory sensitization. Furthermore Sodium cocoamphopolycarboxyglycinate (Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts with CAS no 2060541-51-5) is an aqueous solution with a low vapour, therefore inhalation exposure is unlikely.
Justification for classification or non-classification
Skin
Sodium cocoamphopolycarboxyglycinate (Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts with CAS no 2060541-51-5) and the other three substances within the amphoteric, glycinate substane group, are not found to be skin sensitizers. This is based on the two available in-vivo studies, one performed on Sodium cocoamphopolycarboxyglycinate (Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts with CAS no 2060541-51-5) and the other on Sodium tallowamphopolycarboxyglycinate (Amines, N-[3-[(3-aminopro yl)amino]propyl]-N’-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-47-9). Together with the available QSAR data, the overall conclusion is that the four amphoteric glycinate substances have low potential for skin sensitising properties.
Inhalation
Sodium cocoamphopolycarboxyglycinate (Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts with CAS no 2060541-51-5) has no skin sensitising properties. This together withthe overall information on the amphoteric glycinate substancesindicates that the substance is unlikely to possess any significant potential for respiratory sensitization. All of the amphoteric glycinate substances are produced and handled as aqueous solutions with low vapour pressures, therefore inhalation exposure is unlikely. Data on acute inhalation is lacking, but taken the result from the skin sensitization study and the low potential for inhalation exposure into consideration, the substance it is not classified as a respiratory sensitizer.
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