8.1.2. Animal testing

Definition

Solvay provides innovative products for a wide variety of uses and a large number of users. The Group must have a proper understanding of products’ hazards to carry out its activities and to protect users, the general public, Solvay personnel, and the environment. Society expresses a continuing demand for new, better, and safer chemicals and plastics. There is a growing demand for product risk and hazard assessments by regulatory authorities and the public which, in turn, requires testing, both with and without using animals.

Management approach

Testing

To comply with new and existing chemical regulations or to further consolidate safety data, Solvay commissioned animal tests in 2019. Though Solvay avoids animal testing whenever possible, when it is needed, Solvay commits to conducting studies that treat animals humanely, giving them the best care possible, and using all animals responsibly, with great regard for the animals’ welfare. In compliance with European cosmetic regulations, Solvay does not perform specific testing solely to support cosmetic uses.

Substance-based testing for multiple applications

Solvay manages to carry out tests on a given substance one time only, for all regulations and applications. The need for new studies is avoided by advocating actively for the re-use of data from studies conducted in the framework of the REACH Regulation for other registration systems.

Ethical compliance

Solvay’s policy is to apply in each case the “3R principles” (Replacement, Reduction, and Refinement) and to comply with all applicable regulations. All studies comply with international standards (e.g. OECD-guidelines).

All regulatory studies are performed by laboratories accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). This world-wide organization sets quality standards for testing laboratories and ensures responsible and humane treatment of laboratory animals.

Prior to initiation, all studies commissioned by Solvay are subject to an ethical assessment at the local or national level by the laboratory conducting the study. Once a study is underway, Solvay staff monitor the execution and quality of the studies and maintain a continuing qualification and evaluation program for the laboratories.

Solvay Animal Care and Use Procedure

Solvay’s long-standing Animal Care and Use Procedure is based on the 3Rs. This procedure was updated in 2019 to reinforce the quality of the reporting, but Solvay’s principles and commitments remain unchanged. All Solvay employees and business units are obliged to adhere to this procedure. A dedicated Solvay corporate committee monitors compliance with the procedure annually. This committee reviewed the animal testing activities commissioned by Solvay during 2019, verifying conformity with the principles and the mandatory elements of Solvay’s Animal Care and Use procedure.

Indicators

Regulatory testing

In 2019, 86% of the vertebrate animals tested (representing 55% of the animal studies) were used to address mandatory requirements from authorities, especially European authorities, while the remaining 14% were used to address additional product safety questions. Studies involving vertebrate animals represent the smaller part of the total number of hazard assessment studies conducted 2019, i.e. less than 30%.

Tests on vertebrates

In total, 10,049 vertebrate animals (72% rats, 11% rabbits, 10% fish, 4% guinea pigs, and 3% mice) were used in 2019. Solvay did not commission any studies on dogs, cats, pigs, or non-human primates. Most vertebrate animals (79%) were used in tests required by the REACH Regulation. The number of vertebrates in 2019 used was significantly higher than in 2018 (4,421). The numbers of animals used for Product Support in 2019 was the highest of the past eight years (median: 523 animals).

Trends in the numbers

Over the past seven years, usage of vertebrate animals for hazard assessment has fluctuated significantly (minimum 3,353 in 2017, maximum 11,242 in 2016). The numbers for a given year are primarily driven by the number of regulatory, higher-tier studies (advanced tox studies triggered when more specific / more robust tox data is required; they typically require higher numbers of animals). In 2019, four reproductive toxicity studies were conducted, corresponding to 40% of all animals used.

The number of animals used for product support was higher than in previous years. This was necessary to update the biocompatibility assessments of products for medical devices applications to meet new requirements in this area. The data generated by Solvay will be used by its clients to ensure regulatory compliance. The important information obtained from Product Support studies could not be obtained via other (non-animal) methods.

In collaboration with research and innovation units, the first pilots of a Minimum Dataset approach were conducted in 2019. This methodology aims at identifying early warnings in research projects using non-animal methodologies, allowing safe handling of products, and avoiding “unexpected issues” from obligatory animal studies at a later stage in the development of the project. Typically, the approach starts by using a series of computer predictions which, depending on the progress of the research project, were further supported with cell-based (in vitro) assays. Only in one case was an animal study used because an in vitro method was not available.

Drivers for the future

While studies are needed for regulatory and scientific purposes, Solvay continues to strengthen its capabilities in and understanding of alternative methodologies without vertebrate animals. Advances were achieved on quantitative structure-activity relationships (QSARs), a computer-based method predicting the properties of chemicals based on information on similar substances. A collaboration with the University of Strasbourg resulted in two peer-reviewed articles in 2019 about models that make it possible to estimate substance properties which normally require animal tests. These models will increase our ability to avoid animal testing when assessing our products.

On the other hand, the higher tier animal studies requested by authorities, which required the largest number of animals in 2019, will continue to be the major driver for animal tests in the near future. Because of that, no structural decrease of the number of animals used is foreseen in the years to come.

In some markets (e.g. home and personal care), client demands are rising for products not tested on animals. Solvay is committed to meeting these demands to the extent that the hazard properties of these products can be sufficiently identified using existing information (on similar substances) and additional experiments not involving animals. In the longer term, this customer demand (in some markets) could drive a structural reduction of vertebrate animal studies.