Registration Dossier

Administrative data

Description of key information

In reliable studies (RL 1, guideline studies) performed with the submission substance no irritating potential on skin was found and only slight and transient irritating effects on the eyes were observed. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Both studies either on skin or eye irritation were performed using the submission substance (6-(isononanoylamino)hexanoic acid, compound with 2,2’,2’’-nitrilotriethanol (1:1))

- and were rated as reliable without restriction (reliability category 1).

The primary skin irritation potential of the test material was investigated according to OECD test guideline no 404.The test item (0.5 mL) was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the test item. No erythema or edema were observed at any time point (score 0).There was no indication of systemic toxicity.

The test item was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405. For this purpose 0.1 mL of test material were instilled in the left conjunctival sac of three New Zealand white rabbits. Chemosis was observed in all three animals 1 h after application (maximum score observed 2). The effect was fully reversible within 72 hours. Conjunctival redness was observed in all three animals up to 72 h after application (maximum score observed 3), but was reversible within seven days. Iridial effects were noted in two animals up to 24 h (maximum score observed 1). Corneal opacity was not oberved in any animal.


Justification for selection of skin irritation / corrosion endpoint:
Only reliable study performed with submission substance

Justification for selection of eye irritation endpoint:
Only reliable study performed with submission substance

Justification for classification or non-classification

Based on the results of available data the submission substance does not have to be classified for irritating effects on skin or eyes according to the criteria of Regulation (EC) No. 1272/2008 (CLP) as well as Council Directive 67/548/EEC.