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EC number: 283-585-7 | CAS number: 84682-23-5
In a K2 in vivo skin irritation study in New Zealand White rabbits according to the OECD guideline N°404 and the EU Method B.4, no evidence for skin irritation was noted for T001159.
In a K1 Bovine Corneal Opacity and Permeability (BCOP) test, performed according to OECD guideline 437 and EU method B.47, T001159 did not induce occular irritation. No classification is required for eye irritation or serious eye damage.
Sanders (2005) investigated acute dermal irritation of T001159 in New Zealand White rabbits (3 males after 4 hours of exposure to 0.5 g of test item). Skin reactions were recorded 1, 24, 48 and 72 hours after administration and scored according to the Draize scale.
There were no signs of irritation for any animal during the 72-hour observation period the following the 4-hour exposure period. The test item did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations Commission Directive 2001/59/EC.
An in vitro skin irritation study was waived based on the justification that adequate data from an in vivo skin irritation study are available.
Eurlings (2015) investigated eye irritation in an in vitro bovine corneal opacity-permeability (BCOP) assay. 750 µl of a 20% (w/v) suspension of the test item was applied on the top of 3 corneas for 240 minutes. Both opacity and permeability were measured and the resulting objective values were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS). The corneas treated with T001159 were clear after 240 minutes of treatment. The test item did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -0.2 (-1.6 to 1.4). Since the test item induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
In addition, a rabbit enucleated eye test (REET) was performed by Sanders (2005) to assess the ocuar irritancy potential of T001159. Three enucleated eyes, obtained from the New Zealand White strain of rabbit, were treated with 0.1 ml of T001159 (approx 74 mg). Corneal opacity (60, 120, 180 and 240 minutes after application), corneal swelling (60, 120 and 240 minutes after application) and fluorescein uptake (240 minutes after application) were observed and scored.
The test item had no effect on corneal opacity and corneal epithelium condition at any time. There was no fluorescein uptake by any eye at any time observed, and only minimal corneal swelling (7.1 - 10.5%). The test item was not considered to have the potential to cause severe occular irritancy in vivo.
The BCOP study is considered the key result for assessing the eye irritation endpoint. According to Chapter R.7a: Endpoint specific guidance Version 5.0 - December 2016 (R.126.96.36.199), data obtained from non-validated suitable in vitro tests can only be used according to the criteria set out in section 1.4 of Annex XI to the REACH Regulation, i.e. only positive results can be accepted in a weight of evidence approach. As the result of the non-validated REET test was negative, this study was added to the dossier as supporting evidence and the newly conducted and validated BCOP study is selected as key study for classification purposes.
According to the in vivo acute dermal irritation study no evidence for skin irritation was noted for T001159. The test item did not meet the criteria for classification as irritant or corrosive according to the criteria of the CLP regulation (EC) No 1272/2008.
According to the in Bovine Corneal Opacity and Permeabilty (BCOP) test, T001159 induced no ocular irritation. The test item did not meet the criteria for classification and no classification is required for eye irritation of serious eye damage according to the criteria of the CLP regulation (EC) No 1272/2008.
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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