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EC number: -
CAS number: -
Skin irritation (OECD 431/404): not corrosive/not irritatingEye irritation (OECD 437/405): not irritating
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.
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.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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