Orthoboric acid, compound with 2,2',2''-nitrilotriethanol

Endpoint summary

Description of key information

Skin Irritation: In an in vitro study the test material was determined to be non-corrosive

Eye Irritaion - In a BCOP in vitro study the test material was determined not be a severe irritiant or corrosive

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

Skin Irritation

The skin irritation potential of the test material was evaluated by using a human three dimensional epiderm skin model in accordance with the standardised guideline OECD 431 and under GLP conditions. It was assigned a reliability score of 1 in accordance with the criteria detailed by klimisch (1997).

The possible corrosive potential of TEA borate was tested through topical application for 3 minutes and 1 hour. The test substance was applied undiluted directly on top of the skin tissue.

The positive control had a mean relative tissue viability of 7% after the 1 -hour exposure. The absolute mean OD570 of the negative control tissues was within the acceptance limits of OECD 431 and the laboratory historical control data range. In the range of 20 -100% viability the Coefficient of Variation betweeb tissue replicates was < 6% indicating that the test system functioned properly.

Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 3 minutes and 1 hour treatment with the test item compared to the negative control tissues was 102% and 78%, respectively. Because the mean relative tissue viability for TEA borated was not below 50% after the 3 minute treatment and not below 15% after the 1 hour treatment, the test substance is considered to be not corrosive.

Eye Irritation

The eye irritation potential of the test material was evaluated in vitro using the Bovine Corneal Opacity test (BCOP) test in accordance with the standardised guidelines OECD 437 and EU MEthod B.47 under GLP conditions. It was assigned a reliability score of 1 in accordance with teh criteria detailed by klimisch (1997).

Screening for the eye irritancy potential of the test material was carried out through a 10 minute topical application. The test material was applied as it is (purity 88%) directly on top of the corneas. The negative control responses for opacity and permeability were less that the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control was 53.2 and was within two standard deviations of the current historical positive control mean.It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

The test substance did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 1.5 after 10 minutes of treatment.

In conclusion since TEA borate induced an IVIS of less than 3 no classification is required for eye irritation or serious eye damage.

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