|Substance Group: Diethylenglycol n-butylether|
2-(2-Butoxyethoxy)ethanol (C8H18O3, CAS No: 112-34-5) is a high production volume (HPV) chemical, for which a European Union Risk Assessment is available (European Commission, 2000). This EU risk assessment includes an environmental risk assessment for the tonnage of 2-(2-Butoxyethoxy)ethanol (henceforth referred to as DEGBE) used for detergent applications in private use, and also human health risk assessments covering the use of household cleaning products containing DEGBE which are within the scope of HERA.
HERA is determined to avoid any duplication of effort and to discourage effort for the sake of marginal improvements. However, HERA believes that HERA Risk Assessments should be carried out where significant additional risk information can be obtained, and where a refinement of the existing assessments would yield new or significantly different conclusions in particular for the detergent use scenario.
This document solely refers to the information in the EU Risk Assessment which covers DEGBE use in the household cleaning products which are within the scope of HERA. It also contains additional, recent use information collected from the HERA formulator companies in 2002, which shows a substantial subsequent decrease in DEGBE use in household cleaning products (AISE 2002). Additional toxicological data have become available after the finalisation of the EU Risk Assessment (eg high quality 90d drinking water study) that will be published in the framework of the OECD ICCA activities shortly. This information has not been considered here, especially as the risk assessment and its conclusions were not affected.
In the EU risk assessment (European Commission, 2000), approximately 59% of DEGBE production is estimated to be used in cleaning agents, including floor and metal cleaners, of which approximately 17,250 tonnes are used in household cleaning products. The reference year for the data in the EU risk assessment is 1994. More recent HERA information (AISE 2002) indicates that DEGBE use in products within the scope of HERA has since decreased to less than 2900 tonnes per annum.
The EU risk assessment found that DEGBE is used in consumer products as a mutual solvent for soap, oil, and water in household cleaners. A specific scenario covering consumer use of a hard surface cleaner containing 9% DEGBE was used in the risk assessment for consumers. This risk assessment compared the yearly average inhalatory exposure to DEGBE in hard surface cleaners of 0.068 mg/m3 with the inhalatory NOAEL of 94 mg/m3 found in the 90-day rat study. It found the margin of safety of 1382 to be sufficient. Thus for DEGBE use in products which come within the scope of HERA the risk assessment reached conclusion ii -there is at present no need for further information and/or testing or for risk reduction measures beyond those being applied. The more recent HERA information (AISE 2002) indicates that the maximum DEGBE concentration in products within the scope of HERA has decreased to 6%, as compared with the 9% used in the specific consumer use scenario in the EU risk assessment (European Commission, 2000), for which conclusion ii was reached. This would increase the margin of safety to more than 2000.
Man indirectly exposed via the environment was also considered in the EU risk assessment for DEGBE. Conclusion ii - there is at present no need for further information and/or testing or for risk reduction measures beyond those being applied was found for repeated exposure to DEGBE via the air. The margin of safety for DEGBE in detergent cleaning products in private use was 1.26 X 106. Conclusion ii was also reached for the total intake via air, drinking water, and food, where the margin of safety for DEGBE used privately in detergent cleaning products was 3.47 x 105. Conclusion ii was also reached for reproduction toxicity. Thus for DEGBE use in products which come within the scope of HERA the EU risk assessment found that there is at present no need for further information and/or testing or for risk reduction measures beyond those being applied - with regard to man indirectly exposed via the environment. More recent data (AISE 2002) shows that the amount of DEGBE used in products covered by HERA has decreased significantly, thus increasing the margins of safety given in the EU risk assessment (European Commission, 2000).
In the view of the extensive database on toxic effects and the exposure levels in the intended use patterns of the HERA applications, it can be concluded that the use of DEGBE in household cleaning products raises no safety concern for consumers.
With respect to the environment, the EU risk assessment for DEGBE (European Commission, 2000) concludes that there is no need for further information and/or testing: conclusion (ii), for DEGBE in products within the scope of HERA (i.e. private use of detergent products). The conclusion applies to the aquatic and terrestrial compartments, and to sewage treatment plants. Thus DEGBE use in products which are covered by HERA are not a subject of concern in the EU, with regard to the environment. There has been a significant reduction in DEGBE tonnage used in surface cleaning products (AISE, 2002) since the EU risk assessment was written.