Registration Dossier
Registration Dossier
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EC number: 825-518-1 | CAS number: 2060541-47-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- Read across (Category)
The available data on this endpoint is consistent within the group. Reliable in vivo skin corrosion/irritation studies are available on the two substances with the shortest alkyl chain, as well as the substance with the longest alkyl chain, showing no skin irritating properties. This data is backed up with in vitro studies on the smallest (shortest alky chain, lowest number of amine and carboxymethylated groups) as well as the biggest structure (longest alkyl-unsaturated chain, highest number of amine and carboxymethylated groups) within the amphoteric, glycinate group. Interpolation of the data within the group is therefore possible. Both the in vitro data as well as the in vivo skin irritation tests indicates low skin irritating properties. All the tests are performed on the technical products (a.i. 40 % aqueous solutions). The neat substances may potentially have more irritating properties. This would be in line with the QSAR models estimating the skin irritating properties on the pure substances to be mildly irritating. But as the substances exclusively are produced, handled and marketed as water based solutions, it is not considered relevant to test the neat substances.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test material
- Reference substance name:
- Amines, N-C8-22-alkylpolytrimethylenepoly-, carboxymethyl derivs., sodium salts
- EC Number:
- 307-458-3
- EC Name:
- Amines, N-C8-22-alkylpolytrimethylenepoly-, carboxymethyl derivs., sodium salts
- Cas Number:
- 97659-53-5
- Details on test material:
- Description: amber-coloured liquid
Container: glass screw-top bottle
Sponsor's identification : AMPHOLAK X00-30P
Date of arrival : 15 April 1987
Storage conditions : room temperature
Constituent 1
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours
- Score:
- 0.53
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Irritant / corrosive response data:
- Very slight erythema was noted at all test sites one hour after removal of the wrapping and at the 24-hour observation but persisted at only one test site at the 48 and 72-hour observations. Very slight oedema was noted at all test sites one hour after removal of the wrapping but at only one test site at the 24-hour observation. All test sites appeared normal on day seven.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Two skin irritation / corrosion studies are available on Coco iminodiglycinate, (Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts with CAS no 2098351-38-1). The key study is an in-vivo study performed in 2016 according to the OECD Guideline 404 and under GLP. It has reliability rating 1 and classifies the substance as not irritating. This is backed up by an in-vitro study from 2016, as well as the available in-vivo and in-vitro data on the other two substances within the group Sodium cocoamphopolycarboxyglycinate (Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts with CAS no 2060541-51-5) and Sodium oleylamphopolycarboxyglycinate (1,3-Propanediamine, N1-(3-aminopropyl)-N3-[3-[(9Z)-9-octadecen-1-ylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-49-1) all showing consistent negative results.
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