10-Undecenamide, N-[3-(dimethylamino)propyl]-

Endpoint summary

Description of key information

Taking all available data into account in a weight of evidence approach, the substance is classified as corrosive to skin and eye and will probably be highly irritating to the respiratory trakt.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin Irritation/corrosion:

In an In Vitro Skin Corrosion: Human Skin Model Test according to OECD Guideline 431 (adopted 13 April 2004) and EU Method B.40: "Skin corrosion" (8 June 2000), the topical application of the substance ( 89% a.i.) on the skin tissue for a 3 minutes and 1 hour period was performed, followed by immediate determination of the cytotoxic (corrosive) effect. Cytotoxicity was expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) at the end of the treatment. It is concluded that this test is valid and that test substance is corrosive in the in vitro skin corrosion test under the experimental conditions described.

In a Primary Dermal Irritation Study according to OECD Guideline 404 and EU Method B.4, the right intact and left scarified back of six White New Zealand rabbits was dermally exposed to 0.5 ml of the substance (Fettsäuredimethylaminopropylamid; no data on a.i.) for 4 hours under occlusive conditions. Animals then were observed for 72 hours. Irritation was scored by the method of Draize as stipulated by OECD Guideline 404. The animal showed no skin reactions at all. The mean scores at 24, 48 and 72 h after patch removal were 0. In this study the test substance is not a dermal irritant but due to missing information on purity and composition the test result is not considered reliable without restrictions. Furthermore the test result does not fit into the overall data on skin and eye irritation.

In a Sensitization Study with the substance (a.i. 98.4 %) performed according to OECD 406 on Guinea pig the direct evidence of a probable corrosive effect of the test substance applied to to skin was confirmed.

Dermal application of the 100 %, 75 %, 50 % and 25 % (w/w) concentration of the test substance in vehicle without Duhring Chambers for a 24-hour exposure period led to necrosis of the treated skin sites. The test substance preparation of 5 % (w/w) concentration showed a very slight reaction. Application of the 1 %, 0.5 % and 0.1 % (w/w) concentration in vehicle showed no reaction on the skin.

Two animals of the pilot experiment have been sacrificed by an overdose of a narcotic substance due to the strong skin reactions.

The intradermal application of the 5 %, 3.5 % and 2 % (w/w) solutions of the test substance in vehicle induced a strong skin reaction and moderate skin reaction was observed with the 0.5 % and 0.1 % (w/w) concentration. Slight skin reaction was observed with the 0.05 % (w/w) concentration.

Eye irritation:

In the Primary Eye Irritation Study according to OECD Guideline 405 and EU Method B.5, 0.1 g of the substance (Fettsäuredimethylaminopropylamid; no data on a.i.) was instilled into the conjunctival sac of six White New Zealand rabbits. The eyes of three animals were rinsed 4 seconds after substance application. Animals were observed for 72 hours. Irritation was scored by the method of Draize as stipulated by OECD Guideline 405. In unrinsed eyes severe eye reactions were seen at 60 minutes and 24 hours (Cornea scores of 0 or 1, Iris scores of 1 or 2, Conjunctivae redness scores of 2 or 3, Conjunctivae chemosis scores of 3 or 4). The animals were killed 24 h p.a. due to the severe eye reactions.

In rinsed eyes the test substance induced moderate irritation with Cornea scores of 0, Iris scores of 0 or 1, Conjunctivae redness scores of 2 or 3 and Conjunctivae chemosis scores of 2 or 3 after 60 minutes and24 hours respectively.The observation time did not extend beyond 72 hours, even though severe eye responses were still present, therefore, the reversibility of the eye effects could not be evaluated. The test substance was judged to be irritating to the eye based on the effects of the rinsed eye within 72 hours. Due to missing information on purity and composition the test result is considered reliable with restrictions.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Effects on respiratory irritation: highly irritating

Justification for classification or non-classification

In conclusion, and taking into account all available information in a weight of evidence approach, the test substance has to be classified as corrosive to the skin according to Directive 67/548/EEC. The human skin model allows at present only a classification into Skin Corrosion Category 1A according to GHS Regulation EC No 1272/2008. As no additional information in order to discriminate between Skin Corr. 1A/1B/1C can be retrieved from the available in vivo test Skin Corr. 1 must be chosen.

In conclusion, and taking into account all available information on skin and eye irritation in a weight of evidence approach, the test substance has to be classified as corrosive to the eye according to Directive 67/548/EEC and Category 1 (Irreversible effects on the eye) according to GHS Regulation EC No 1272/2008.