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Toxicological information

Skin irritation / corrosion

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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:
1993
Report date:
1993

Materials and methods

Test material

Constituent 1
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

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.