Solvay provides innovative products for a wide variety of uses and a large number of users. A proper understanding of products’ hazards is indispensable to allow the Group to continue its activities and to protect users, the general public, Solvay personnel, and the environment. Society is continually demanding 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, necessitates testing, both with and without using animals.

Management approach

Testing

To comply with new and existing chemical regulations and to address internal requests related to Product Safety, Solvay commissioned animal tests in 2018. Though animal testing is avoided by Solvay whenever possible, when animal testing is needed, Solvay commits to conducting studies that treat animals humanely and responsibly, with regard for the animals’ welfare. In compliance with European cosmetic regulations, Solvay does not conduct specific testing solely to support cosmetic uses. 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).

Substance-based testing for multiple applications

Solvay manages to carry out tests on a substance one time only, for all regulations and applications. New studies are avoided by advocating actively for the re-use of data from studies conducted in the framework of the REACH Regulation for other registration systems, or by challenging high-tier animal testing directly with the representatives of local authorities (e.g. Korea REACH and Chinese New Chemical Substance Notification).

Ethical Compliance

Solvay’s long-standing Animal Care and Use Standard is based on the "3R principles": Replacement, Reduction, and Refinement. All regulatory studies are performed by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC)-accredited laboratories. This worldwide organization sets the 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 operate a continuing qualification and evaluation program for the laboratories in place.

Solvay Animal Care and Use Standard

The Solvay Animal Care and Use Standard was updated in 2015 and implemented in 2016. All Solvay businesses are required to adhere to this standard. A Solvay corporate committee is in charge of monitoring compliance with the standard. This committee reviewed animal testing activities commissioned by Solvay during 2018 and checked conformity with the principles and the mandatory elements of Solvay’s Animal Care and Use standard.

Indicators

Vertebrate animal tests commissioned by Solvay in 2018

 

 

Number of studies

 

Number of vertebrates

Registration obligations (EU, China, Korea)

 

25

 

4,268

Additional product safety questions (toxicity, classification)

 

9

 

153

Total

 

34

 

4,421

Regulatory testing

In 2018, 97% of the vertebrate animals (representing 74% of the studies) were used to address mandatory requirements from authorities, especially European authorities, while the remaining 3% were used to address additional product safety questions.

Tests on vertebrates

A total of 4,421 vertebrate animals (71% rats, 22% fish, 5% mice, 1% rabbits, and 1% guinea pigs) were used in 2018. Solvay did not commission any studies on dogs, cats, pigs, or non-human primates. The number of vertebrates used was comparable to previous years, whereas the number of animal studies was at least 30% lower than the five previous years. There is a significant heterogeneity between studies: two particular studies, both investigating reproductive toxicity, represent more than half of the animals used in 2018. Many studies were carried out via consortia, sharing results and animal use between member companies, thereby significantly reducing the number of studies and animals needed.

Trends in the number of studies

Solvay adheres to the objectives outlined in Europe’s REACH Regulation, i.e. promoting non-animal testing and the replacement, reduction, and refinement of animal testing. Also in 2018, most vertebrate animals (95%) were used in the framework of tests required by the REACH Regulation. The increased regulatory acceptance of in vitro tests for classification purposes has allowed Solvay to replace a number of in vivo studies with alternative tests, especially in the field of skin irritation, eye irritation and skin sensitization. Another alternative to in vivo testing is the use of in silico methodologies allowing the prediction of substance properties, which is based on existing data on other similar substances (structure-activity relationships). Solvay has continued to apply this methodology as the first-line approach when new information on a substance is required.

Drivers for the future

Various drivers will influence the demand for animal studies in the coming years. On the one hand, demand is expected to increase because of the expected ECHA decisions requesting Extended One Generation Reproductive Toxicity Tests. Moreover, there is an increasing societal demand for better understanding of the complex interactions between (novel) chemicals and biological systems, e.g. regarding carcinogenicity and endocrine disruption. Also, additional countries are adopting REACH-like regulation, pushing for additional data. On the other hand, animal testing will be reduced further thanks to progress on alternative approaches: predicting the behaviour of chemicals based on similar substances or on relationships between structure and properties and hazards, or in-vitro assays. It is worth noting that some markets are now focusing on animal-test free products.