Suitability of the isolated chicken eye test for classification of extreme pH detergents and cleaning products.

A.I.S.E. investigated the suitability of the regulatory adopted ICE in vitro test method (OECD TG 438) with or without histopathology to identify detergent and cleaning formulations having extreme pH that require classification as EU CLP/UN GHS Category 1. To this aim, 18 extreme pH detergent and cleaning formulations were tested covering both alkaline and acidic extreme pHs. The ICE standard test method following OECD Test Guideline 438 showed good concordance with in vivo classification (83%) and good and balanced specificity and sensitivity values (83%) which are in line with the performances of currently adopted in vitro test guidelines, confirming its suitability to identify Category 1 extreme pH detergent and cleaning products. In contrast to previous findings obtained with non-extreme pH formulations, the use of histopathology did not improve the sensitivity of the assay whilst it strongly decreased its specificity for the extreme pH formulations. Furthermore, use of non-testing prediction rules for classification showed poor concordance values (33% for the extreme pH rule and 61% for the EU CLP additivity approach) with high rates of over-prediction (100% for the extreme pH rule and 50% for the additivity approach), indicating that these non-testing prediction rules are not suitable to predict Category 1 hazards of extreme pH detergent and cleaning formulations.

Suitability of histopathology as an additional endpoint to the Isolated Chicken Eye Test for classification of non-extreme pH detergent and cleaning products.

A.I.S.E. investigated the suitability of histopathological evaluations as an additional endpoint to the regulatory adopted ICE in vitro test method (OECD TG 438) to identify non-extreme pH detergent and cleaning products that require classification as EU CLP/UN GHS Category 1 (serious eye damage). To this aim, a total of 30 non-extreme pH products covering the range of in vivo classifications for eye irritation, and representing various product categories were tested. Epithelium vacuolation (mid and lower layers) and erosion (at least moderate) were found to be the most relevant histopathological effects induced by products classified in vivo as Category 1. Histopathology criteria specifically developed for non-extreme pH detergent and cleaning products were shown to correctly identify materials classified as Category 1 based on in vivo persistent effects, and to significantly increase the overall sensitivity of the standard ICE prediction model for Category 1 identification (to 75%) whilst maintaining a good concordance (73%). In contrast, use of EU CLP additivity approach for classification of mixtures was considerably less predictive, with a concordance of only 27%, and 100% over-predictions of non-Category 1 products. As such, use of histopathology as an addition to the ICE test method was found suitable to identify EU CLP/UN GHS Category 1 non-extreme pH detergent and cleaning products and to allow a better discrimination from Category 2 products.

A standard method for measuring benzene and formaldehyde emissions from candles in emission test chambers for human health risk assessment purposes.

Burning candles release a number of volatile or semi-volatile organic compounds (VOC; SVOC) and particulate matters into indoor air. Publicly available candle emission studies vary in protocols and factors known to have a great influence on combustion processes, making it difficult to determine potential implications of candle emissions for human health. The main objective of this investigation was to establish and standardize as far as possible a candle VOC emission testing protocol in small- to mid-scale test chambers on the basis of existing standards as well as to verify its suitability for human health risk assessment purposes. Two pilot studies were conducted to define the boundaries of permissible variations in chamber parameters without significantly impacting the quality of the candle burn. A four-centre ring trial assessed the standardised protocol. The ring trial revealed that when the laboratories were able to control the chamber parameters within the defined boundaries, reproducible formaldehyde and benzene emissions, considered as VOC markers, are determined. It was therefore concluded that the protocol developed in this investigation is suitable for generating candle VOC emission data for human health risk assessment purposes.