Gauke Veenstra

Human health risk assessment of long chain alcohols.

Representative chemicals from the long chain alcohols category have been extensively tested to define their toxicological hazard properties. These chemicals show low acute and repeat dose toxicity with high-dose effects (if any) related to minimal liver toxicity. These chemicals do not show evidence of activity in genetic toxicity tests or to the reproductive system or the developing organism. These chemicals also are not sensitizers. Irritation is dependant on chain length; generally, alcohols in the range C(6-)C(11) are considered as irritant, intermediate chain lengths (C(12-)C(16)) alcohols are considered to be mild irritants and chain lengths of C(18) and above are considered non-irritants. These chemicals are broadly used across the consumer products industry with highest per person consumer exposures resulting from use in personal care products. Margins of exposure adequate for the protection of human health are documented for the uses of these chemicals.

Developmental toxicity of di-(C7-C9 alkyl) phthalate and di-(C9-C11 alkyl) phthalate in the rat

Two phthalate esters, di-(C(7)-C(9) alkyl) phthalate (D79P) and di-(C(9)-C(11) alkyl) phthalate (D911P), have been assessed for their potential to cause developmental toxicity in the rat. Groups of 22 timed-mated Sprague-Dawley rats were administered 250, 500, or 1000 mg/kg D79P or D911P daily by oral gavage (5 ml/kg) between gestation days (GD) 1 and 19. Control animals received the vehicle (olive oil) alone. On GD20, the animals were sacrificed and the fetuses examined. Treatment resulted in no signs of maternal toxicity, as assessed by adjusted maternal bodyweight gain throughout gestation and clinical examinations, and no effects upon litter size, fetal survival or bodyweight. Pups of the high dose D79P and intermediate and high dose D911P groups showed increased incidences of supernumerary lumbar ribs. There was a significant increase in dilated renal pelves in pups of the low dose D79P and high dose D911P groups, but only for D911P was there a significant trend. Consequently, the no observed adverse effect level (NOAEL) for maternal toxicity for both D79P and D911P is 1000 mg/kg/day. The NOAEL values for developmental toxicity are 500 mg/kg/day D79P and 250 mg/kg/day D911P.

An overview of hazard and risk assessment of the OECD high production volume chemical category - long chain alcohols [C6-C22] (LCOH).

This review summarizes the findings of the assessment report for the category, long chain alcohols (LCOH) with a carbon chain length range of C(6)-C(22) covering 30 substances, and >1.5million tonnes/year consumed globally. The category was evaluated under the Organization for Economic Co-operation and Development (OECD) high production volume chemicals program in 2006. The main findings of the assessment include: (1) no unacceptable human or environmental risks were identified; (2) these materials are rapidly and readily biodegradable; (3) a parabolic relationship was demonstrated between carbon chain length and acute and chronic aquatic toxicity; (4) category-specific (quantitative) structure-activity relationships were developed enabling prediction of properties across the entire category; (5) LCOH occur naturally in the environment in an equilibrium between synthesis and degradation; (6) industry coming together and sharing resources results in minimizing the need for additional animal tests, produces cost savings, and increases scientific quality of the assessment.

Environmental properties of long chain alcohols. Part 1: Physicochemical, environmental fate and acute aquatic toxicity properties

This paper summarises the physicochemical, biodegradation and acute aquatic ecotoxicity properties of long chain aliphatic alcohols. Properties of pure compounds are shown to follow somewhat predictable trends, which are amenable to estimation by quantitative structure-activity relationships ((Q)SARs). This allows predictions of data relating to human and environmental safety profiles and patterns. These alcohols have been shown to be rapidly degradable under standard conditions up to C(18). Furthermore, evidence suggests that longer chain lengths are also rapidly biodegradable. While logK(ow) values suggest possible bioaccumulation potential, available data suggest that these substances are not as bioaccumulative as estimations would predict. For acute aquatic toxicity, solubility limits the possibility of effects being appropriately observed and become increasingly challenging above C(12). Further, a model has been developed for multi-component mixtures which give an excellent account of aquatic ecotoxicity allowing for the prediction of acute effects of un-tested mixtures.

The ECETOC approach to targeted risk assessment; lessons and experiences relevant to REACH

ECETOC has been developed an approach by which the health and environmental risks arising from the supply and use of chemicals can be quickly and reliably evaluated by chemical suppliers. The approach has been available as a web-based tool since 2004. During the development and implementation of the approach, ECETOC has consulted widely so that the approach is seen to meet the required levels of science while also meeting the differing needs of affected stakeholders. The consultation process has yielded a number of findings in terms of the considerations necessary for implementing successful risk-informed decision-making in a multi-stakeholder environment. Concurrently, as the European Commissions REACH legislative package has begun to take shape, it has also become apparent that the approach has a number of potential applications for aiding the process of risk assessment under REACH. This paper reviews these experiences within the broader context of the expectations that REACH places on chemical manufacturers and suppliers. In particular, it highlights the key role that REACH Exposure Scenarios have for evaluating, managing and communicating chemical risks.

A structured approach to the evaluation of workplace chemical health risks

Abstract In order to respond to the increasing need for chemical suppliers to evaluate effectively and consistently the likely risks to health that the use of chemicals at work might present, the European Centre for Ecotoxicology and Toxicology of Chemicals has developed a tiered approach to this challenge. It builds on concepts that are already in use in some areas of workplace health and safety but, uniquely, applies them in the context of the chemicals supply chain. The approach applies these concepts in a series of tiers, in order to target, with increasing certainty, those situations that present a potential risk to human health. Adopting such an approach provides an ability to align the responsibilities and expectations of employers more closely with those of chemicals suppliers. This paper provides an overview of the approach and, specifically, a detailed commentary on the process used to evaluate workplace risks arising from the use of chemicals. It provides evidence, based on a limited validation exercise, that the approach not only serves as a useful tool in the product stewardship aspirations of the chemical industry, but potentially has a wider role within the context of the ongoing discussions in Europe on a new framework for the control of chemicals.