Registration Dossier
Registration Dossier
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EC number: 268-952-1 | CAS number: 68155-26-0
Endpoint summary
Administrative data
Description of key information
Skin: corrosive
Eye: corrosive
Key value for chemical safety assessment
Additional information
Skin
A study was conducted to assess the irritation potential of amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl), CAS 68155-07-7 to rabbit skin, for 4 h, according to OECD 404 and a summary of the results available. Animals were observed for 25 days. Strong erythema and oedema were observed in all animals, but after 25 d, 2/3 animals had fully recovered. The similar substance can be considered as highly irritating to rabbit skin under the conditions of the study. 1
Data from another study on Amides, C12-18 (even-numbered) and C18 (unsatd.), N,N-bis(hydroxyethyl), CAS 90622-74-5 are available. The shaved skin of 5 rabbits was exposed to the undiluted test substance using occlusive patches for 4 hours. The substance caused light to moderate erythema and light oedema and therefore it is considered to be irritating to rabbit skin.2
A summary on a study on a similar vegetable substance Amides, soya, N,N-bis(hydroxyethyl), CAS 68425-47 -8 is available.
The study was performed on OECD 404, the substance applied for 4 hours and the animals observed for 25 days. Strong erythema and strong oedema were observed in all animals. Slow recovery occured, under thick scabs. After 25 days, 2/3 animals had fully recovered. In the third animal, scabs were falling away.The overall irritation index was 7/8 so that the undiluted test substance can be considered highly irritating to rabbit skin under the conditions of the study.3
Diethanolamine is irritant to the skin and it is classified for irritation according to the Annex VI of the Regulation (EC) No 1272/2008.4
Eye
A study on amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl) CAS 68155-07-7 to rabbit eye was performed and a summary of the results available. The test was performed in accordance with OECD Guideline 405. Two out of three animals showed opacity of the cornea as well as slight corneal reddening and circumcorneal injection. In all animals, moderate to strong erythema and slight swelling of the conjunctivae were noted. The similare substance can be considered moderately irritating to rabbit eye.1
Data from a study performed to assess the eye irritation potential of amides, C12-18 (even-numbered) and C18(unsatd.), N,N-bis(hydroxyethyl) CAS 90622-74-5, according to OECD Guideline 405 are available.Four rabbits received 0.01 mL of an undiluted solution in one eye. The other eye remained untreated. After 1, 6, 24, 48 and 72 hours, then 7, 10, 14, 17 and 21 days, eyes were analysed for reaction based on the Draize scoring method. On the cornea, slight to moderate opacity was observed in all treated eyes. The reaction was irreversible. Irreversible effects were also noted in the iris of one animal. Finally, all animals presented moderate to severe redness, chemosis, and/or exudation (sometimes infiltrated with blood) of the conjunctivae, which did not entirely disappear by the end of the 21 days observation period.
Under the test conditions, this similar substance was considered to be highly irritating to the rabbit eye.2
A summary on a study on a similar vegetable substance Amides, soya, N,N-bis(hydroxyethyl), CAS 68425-47-8 is available.
The test substance was applied neat to the left eye of three rabbits. Animals were then observed for 17 days. Two out of three animals showed opacity of the cornea as well as slight corneal reddening and circumcorneal injection. These effects were reversible within 10 days. In all animals, moderate to strong erythema and slight swelling of the conjunctivae were noted. This was reversible within 13 days. The overall irritation index was 34.9/110. Under the conditions of this study, the test substance was considered moderately irritating to rabbit eye.3
The ocular irritation of a chemical substance composed by Cocamide DEA with free of Diethanolamine at the effective concentration of > 0.3%, was evaluated on rabbits, according to the Draize eye irritation procedure. The product was a severe ocular irritant, due to the corneal damage resulted during the test.5
Ambiguous results are reported in studies of diethanolamine, present in the intermediate as a free component in a small amount. Therefore the substance is considered not irritant to the eyes.4
Reference:
1ECHA Registration Dossier Amides, C8-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl), CAS 68155-07-7
2ECHA Registration Dossier Amides, C12-18 (even-numbered) and C18 (unsatd.), N,N-bis(hydroxyethyl), CAS 90622-74-5
3ECHA Registration Dossier Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl), CAS 68603-38-3
4ECHA Registration Dossier 2,2'-iminodiethanol CAS 111-42 -2
5Amended Final Report on the Safety Assessment of Cocamide DEA, Journal of the American College of Toxicology, 15 (6): 527-542, Cosmetic
Ingredient Review, 1996.
Effect level: empty Endpoint conclusion: Adverse effect observed
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
Skin corrosion/irritation
In order to classify the PRODUCT L6143 for the skin irritation, the available classification (from Harmonized classification, Registration dossier and CLP notification) and the results of the reported studies of every known component and the similar substances have been taken into account.
Amides, C8-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl), CAS 68155-07-7: H315
Amides, C12-18 (even-numbered) and C18 (unsatd.), N,N-bis(hydroxyethyl), CAS 90622-74-5: H315
Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl), CAS 68603-38-3: H315
Lauramide diethanolamine (LDEA) CAS 120-40-1: H315
Coconut fatty acid diethanolamide, Amides, coco, N,N-bis(hydroxyethyl), CAS 68603-42-9: H315
Diethanolamine, CAS 111-42-2: Index number 603 -071 -00 -1, Annex VI of CLP Regulation 1272/2008/EC: H315
Amides, vegetable-oil, N,N-bis(hydroxyethyl) are the major component (a 86 %), followed by diesters of fatty acids of diethanolamine.
A small amount of diethanolamine (2-5%) is present.
All the component are considered irritant for the skin.
According to the CLP Regulation 1272/2008/EC, 3.2 section, point 3.2.3.3, Table 3.2.3, generic concentration limits shall be used to determine if the mixture is considered to be an irritant or a corrosive to the skin.
However, according to the point 3.2.3.3.4.2, the pH shall be used as a classification criterion.
The measured pH of the product is almost 11.2 -11.6 (10% in water), therefore it has corrosion properties for the skin.
Based on the information available an the evaluation of the pH, the intermediate PRODUCT L6143 is classified as a skin corrosive, Category 1, H314.
Eye corrosion/irritation
In order to classify the PRODUCT L6143 for the eye irritation, the available classification (from Harmonized classification, Registration dossier and CLP notification) and the results of the reported studies of every known component and the similar substances have been taken into account.
Amides, C8-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl), CAS 68155-07-7: H318
Amides, C12-18 (even-numbered) and C18 (unsatd.), N,N-bis(hydroxyethyl), CAS 90622-74-5: H318
Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl), CAS 68603-38-3: 319
Lauramide diethanolamine (LDEA) CAS 120-40-1: H318
Coconut fatty acid diethanolamide,Amides, coco, N,N-bis(hydroxyethyl)CAS 68603-42-9: H318
Diethanolamine, CAS 111 -42 -2: Index number 603 -071 -00 -1, Annex VI of CLP Regulation 1272/2008/EC: H318
Amides, vegetable-oil, N,N-bis(hydroxyethyl) are the major component (a 86 %), followed by diesters of fatty acids of diethanolamine.
A small amount of diethanolamine (2-5%) is present.
All the component are considered corrosive for the eye.
According to the CLP Regulation 1272/2008/EC, 3.3 section, point 3.3.3.3, Table 3.3.3, generic concentration limits shall be used to determine if the mixture is considered to be an irritant or a corrosive to the eye.
However, according to the point 3.2.3.3.4.2, the pH shall be used as a classification criterion (>=11.5)
The measured pH of the product is almost 11.2 -11.6 (10% in water) , therefore it has corrosion properties for the eye.
Based on the information available, the intermediate PRODUCT L6143 is classified as an eye corrosive, Category 1, H314.
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