N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)

Endpoint summary

Description of key information

Skin irritation/corrosion:

The test substance is considered to be corrosive to skin based on skin irritation studies conducted in rabbits that reported severe irritation (erythema) and corrosion following a 60-minute exposure to the test substance.

Eye irritation:
The test substance is considered to be corrosive to the eyes based on an eye irritation study conducted in rabbits indicating that the test substance is extremely irritating and the effects were not reversible within 72 hours.

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:

no study available

Additional information

Skin irritation/corrosion

The key skin irritation study had a reliability score of 1 and was GLP compliant (WIL, 1996). The test protocol was OECD 404 and DOT 49 CFR 173.137. One New Zealand White rabbit was dosed to evaluate the irritative/corrosive potential of the test material for three and 60 minutes. The study consisted of two sequential single 0.5 mL doses of the test material that were applied to the clipped, intact skin of one rabbit under semi-occlusive dressings. Moderate erythema was observed on the 3-minute site immediately following unwrap. Approximately one hour following bandage removal, the 3-minute site had severe erythema, very slight edema and fissuring. There was no evidence of corrosion following the 3-minute exposure. The 60-minute site had corrosion, severe erythema and blanching. Since severe irritation (erythema) and corrosion were observed after the 60-minutes exposure period no further testing was conducted and the study was terminated. Based on the results, a four-hour exposure was not evaluated.

In addition, three reliable supporting studies are available, all of which found the test substance to be corrosive to the skin of rabbits.

No in vitro studies were performed with the test substance.

Eye irritation

The key eye irritation study had a reliability score of 2 and was performed in New Zealand White rabbits using a method equivalent or similar to the OECD 405 guideline and in compliance with the GLP Regulations. Following a one second exposure to the test substance, ocular responses were assessed using the Draize scoring system. Maximum mean total scores (MMTS) at 1 hour, 24 and 48 hours, and 72 hours post-exposure were 75.7, 102.3 and 105.4, respectively. Necrosis of the skin surrounding the treated eyes was also observed during the course of the study. Due to the severity of the reactions prior to the Day 7 reading, the study was terminated. The test substance was reported to be extremely irritating on the basis of the 72-hr Draize Score of 105.4.

No in vitro studies are available for this endpoint.

Justification for classification or non-classification

Based on the available results, the suggested classification for the test substance according to the EU CLP Regulation 1272/2008 is skin corrosion Category 1B and eye damage Category 1 - Causes severe skin burns and eye damage, H314.