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VCI overview on "endocrine active substances"

 

Date: April 7, 2010

 

 

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Since the middle of the 1990s, the issue “chemical substances with endocrine effects” has attracted a lot of attention from the scientific community, the authorities, industry, and organizations active in the field of environmental protection. The media have also picked up the subject and reports published all over the world have carried headlines such as “Fertility crisis”, “Men are disappearing from the world” or “Attack on manliness”. The subject matter of the articles in each case was the assumed causal relationship between contamination of the environment and of humans by environmental chemicals, observed or suspected negative trends in relation to diseases of the reproductive systems of humans and animals, and the influence of chemical compounds on hormonal control systems. Since then, a lot of new information has become available.

The VCI overview on “endocrine active substances” examines the current state of scientific knowledge through discussion of the following issues:

·definition of “endocrine active substances” and “endocrine disrupters”,

·basis of the evaluation,

·background to the substances under discussion and to the question of which hormone systems are under discussion in association with endocrine activity as well as the possible accumulation of endocrine active substances in organisms,

·examples of the potencies of estrogenic substances are described.

In separate sections, the human and environmental aspects are examined in more detail, e.g. the possible hazard to humans or the environment is assessed. In this process, test methods, test strategies, and evaluation concepts are explained.

More general matters, such as what is known about combination effects and the question of adverse effects in the low-dose range are also discussed, as is the subject of the validity and quality of scientific studies.

In the last section, regulatory aspects are discussed, e.g. the question of the need for a separate hazard category and prioritization and evaluation studies for candidate substances.

The VCI overview is intended to make a relevant contribution to the scientific and objective discussion of endocrine active substances. To this end, regular updating of the document to reflect the current state of the discussion is envisaged.

 

Contents:

 

1. Endocrine effects

1.1

What is the endocrine system?

1.2

Definitions: difference between endocrine active substances and “endocrine disrupters”

1.3

Basic principles of the evaluation of endocrine active substances

1.4

What hormone systems are discussed in relation to endocrine activity?

1.4

Do substances with hormonal effects accumulate in the body?

 

2. Example: estrogenic activity

2.1

What are estrogens?

2.2

What substances have estrogen-like activity?

2.3

How potent are substances with estrogen-like activity?

 

3. Endocrine effects – human aspects

3.1

What damage to health is feared?

3.2

What is the current estimate of the possible risk to humans from endocrine active substances?

3.3

What information about hormon-like acting substances can be derived from studies examing classical toxicological endpoints?

3.4

Is screening for hormon-like effects reasonable? Test strategy for the detection of endocrine effects

3.5

Hygiene-based margin of safety (HBMOS) evaluation model from a VCI/UBA joint research project

 

 

4. Endocrine effects – environmental aspects

4.1

Endocrine systems in the animal kingdom

4.2

Adverse effects observed in the environment

4.3

The aquatic environment

4.3.1

The Rhine ecosystem – a well-documented “case”

4.3.2

The sex ratio of freshwater fish – VCI-funded field biology research project

4.3.3

Evaluation of findings from field studies

4.3.4

Informative significance of the biomarker vitellogenin

4.3.5

Informative significance of the Gonadosomatic Index (GSI), gonad histology, and sex ratio

4.4

Informative significance of experimental laboratory studies

4.5

Test strategy for detecting endocrine effects

 

5. Special discussions on the subject of endocrine activity

5.1

Combination effects

5.2

Do endocrine active substances have adverse effects at low doses?

5.3

Potency of industrial chemicals in comparison with naturally occurring substances

5.4

Validity and quality of scientific studies

 

6. Endocrine effects – regulatory significance

6.1

Definitions, risk assessment

6.2

Is a separate hazard category required?

6.3

EU Community Strategy on endocrine disrupters

6.3.1

Lists of candidate substances for further evaluation regarding their endocrine potential

6.3.2

Prioritization and evaluation studies on candidate substances

6.4

Endocrine disrupters in the authorisation procedure of the REACH Regulation (EC) No 1907/2006

7. Summary of the VCI overview


 
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