Registration Dossier

Administrative data

Description of key information

Skin irritation (OECD 431/404): not corrosive/not irritating
Eye irritation (OECD 437/405): not irritating

Key value for chemical safety assessment

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion

To characterize the potency of the test substance to induce skin corrosion, anin vitroskin corrosion test was conducted according to OECD 431 (Lehmeier, 2011b). 25 mg of the test item were applied topically on EpiDermTMhuman skin equivalents (MatTek Corporation, Ashland, USA) after moistening the test item with 25 µL distilled water. After 3 min exposure, cytotoxicity measurements via MTT reduction assay revealed a relative mean tissue viability of 98% which was reduced to 80% after elongation of the exposure period to 60 min compared to the respective controls. In contrast, the positive control substance KOH reduced the relative tissue cell viability to 22% and 13% for 3 or 60 min exposure periods, thereby validating the study. Thus, the test substance is considered to be non-corrosive to skin according to the classification criteria given in OECD 431.

Further, an acute dermal irritation/corrosion study was performed according to OECD 404 (Stelter, D. 2012a). In this study, 3 female New Zealand White Rabbits were exposed to 0.5 g of moistened test item per site for 4 h under semi-occlusive dressings. The single dermal application on clipped skin did not induce irritant or corrosive effects as determined 1, 24, 48 and 72 h after exposure. Further, no mortalities or clinical signs of toxicity were observed. Thus, the test substance is not classified according to GHS. 

 

Eye irritation

The eye irritation potential of the test substance was evaluated in a sequential testing strategy including a validatedin vitroeye corrosion/irritation test prior toin vivotesting as outlined in the OECD test guideline 405 for eye corrosion/irritation. In detail, anin vitrobovine corneal opacitiy and permeability test according to OECD 437 was performed (Lütkenhaus, 2011c). Corneas were exposed to the test substance in the closed-chamber method. Therefore, 750 µL of the test item solution, 20% dissolved in 0.9% NaCl, were introduced in the anterior chamber of the corneal holders for 4 h. Subsequent measurements after rinsing revealed a mean opacity value of 26.0 and a mean permeability value of 0.11 resulting in anin vitroirritancy score (IVIS) of 26.16. According to the evaluation criteria given in OECD 437, the conductedin vitro test did not identify the test substance as an ocular corrosive.

Based on the negative test result, additional testing in rabbits was conducted using a sequential testing strategy according to OECD guideline 405 to enable classification and labelling of FAT 40853. A single ocular dose of 0.1 g was applied to the eye of 3 female New Zealand White Rabbits (Stelter, D. 2012b). After 24 h, the treated eye was rinsed with physiological saline. The test substance induced slight irritant effects in the test animals visible as conjunctival redness and chemosis. In detail, all test animals showed conjunctival redness with grade 1 according to Draize Scoring which was fully reversible latest after 48 h resulting in a mean score over all 3 animals of 0.45 following grading at 24, 48 and 72 h readings. Further, conjunctival chemosis of grade 1 was observed in all 3 animals which was fully reversible within 4 or 5 days. Thus, an overall mean value of 1 was determined over all animals and readings at 24, 48 and 72 h. No effects on the iris or cornea were observed in any test animal and no clinical signs of toxicity or mortalitiy were reported. According to the classification criteria given in GHS, the test substance did not meet the criteria for classification as Eye irritant.

Justification for classification or non-classification

The available data on skin irritation / corrosion and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.