2,2'-[6-(4-methoxyphenyl)-1,3,5-triazine-2,4-diyl]bis{5-[(2-ethylhexyl)oxy]phenol}

Endpoint summary

Description of key information

Not a skin irritant
Not an eye irritant

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 potential of Bemotrizinol to induce skin irritation was evaluated in 3 New Zealand White rabbits (RCC 651431, 1997, OECD 404, GLP). A single dose of 500 mg of the test item in its original form was applied semi-occlusively to the closely-clipped skin of one flank. No cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing. Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for edema. Under the experimental conditions employed, the test item was non-irritant when applied topically to rabbits.

 

Eye irritation:

The potential of Bemotrizinol to induce ocular irritation was evaluated in the key study in rabbits (RCC 651442, 1997, OECD 405, GLP). A single dose of 100 mg of the test item in its original form was introduced into the left conjunctival sac of the eye of three New Zealand White rabbits. The right eye was not treated and served as control. Ocular reactions were observed approximately 1 hour, 24 and 48 hours after the administration. Mean scores calculated for all animals over 24, 48 and 72 hours was 0.44 for redness of the conjunctiva. Other parameters such as corneal opacity, iritis, chemosis were not affected by treatment within 24 -72 hours. Under the experimental conditions employed Bemotrizinol was non irritant when administered by ocular route to rabbits.

Supportive in vitro studies are available to assess the eye damage and irritation potential of Bemotrizinol. In a Bovine Corneal Opacity and Permeability (BCOP) test, 3 corneas were treated with a 20% Bemotrizinol preparation in de-ionized water for an exposure period of 4 hours (BASF 2012; 63V0382/10A438). The in vitro irritancy score (IVIS) for Bemotrizinol was determined to be 6.6 (+/-5.1) and thus, the substance was identified to cause no serious eye damage according to the respective prediction model. The eye irritation potential of Bemotrizinol was determined in an EpiOcular™ eye irritation test via incubation of 2 tissue samples with the undiluted test substance for 90 minutes followed by an 18-hour post-incubation period (BASF 2012; 62V0382/10A242). Mean tissue viability after treatment with Bemotrizinol was 104% compared to the negative control (deionized water). Accordingly, Bemotrizinol did not show any eye irritation potential in this test system under the conditions chosen.

Justification for classification or non-classification

The present data on skin and eye irritation do not fulfill the criteria laid down in regulation (EU) 1272/2008, and therefore, a non-classification is warranted.