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Update on the Endocrine Disruptors: ECHA Substance of Very High Concern (SVHC) and Authorisation List

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Update on the Endocrine Disruptors: ECHA Substance of Very High Concern (SVHC) and Authorisation List
  • 2 new chemicals identified as endocrine disruptors (ED) have been added to the ECHA SVHC list in July 2019

  • The first 4 chemicals to be added to the  Authorisation list were due to their endocrine properties to human health following a recommendation made by ECHA  

Table 1  Recent chemicals added to ECHA SVHC list due to their endocrine disruptor properties.

NAME

CAS

Reason

Dates

Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP)-

 

Endocrine disrupting properties (Article 57(f) – environment)

 

Added to SVHC list July 2019

4-tert-butylphenol-

202-679-0

Endocrine disrupting properties (Article 57(f) – environment)

 

Added to SVHC list July 2019

Benzyl butyl phthalate (BBP)

85-68-7

Toxic for reproduction (Article 57c)#Endocrine disrupting properties (Article 57(f) - human health)

Recommended to be added to Authorisation list July 2019  (added to SVHC list February 2017)

Bis (2-ethylhexyl)phthalate (DEHP)

117-81-7

Toxic for reproduction (Article 57c)#Endocrine disrupting properties (Article 57(f) - environment)#Endocrine disrupting properties (Article 57(f) - human health)

Recommended to be added to Authorisation list July 2019 (added to SVHC list February 2017)

Dibutyl phthalate (DBP)

84-74-2

Toxic for reproduction (Article 57c)#Endocrine disrupting properties (Article 57(f) - human health)

Recommended to be added to Authorisation list July 2019 (added to SVHC list February 2017)

Diisobutyl phthalate

84-69-5

Toxic for reproduction (Article 57c)#Endocrine disrupting properties (Article 57(f) - human health)

Recommended to be added to Authorisation list July 2019 (added to SVHC list February 2017)

Dicyclohexyl phthalate

 

84-61-7

Toxic for reproduction (Article 57c)#Endocrine disrupting properties (Article 57(f) - human health)

Added to SVHC list July 2018

 

Four of the phthalates (Benzyl butyl phthalate (BBP), Bis (2-ethylhexyl)phthalate (DEHP), Dibutyl phthalate (DBP and Diisobutyl phthalate) had already been identified as SVHCs because of their effects on male fertility and have subsequently been added to the Authorisation List due to their classification as toxic for reproduction (Cat. 1B). Once the Commission decides on the amendment, some previously exempted uses may require authorisation.

These phthalates have constituted a precedence as it was the first time that chemicals have been identified as substances of very high concern (SVHC) due only to their potential endocrine disrupting properties (EDPs) in humans (2017) and the following year an additional member of the phthalates family

(Dicyclohexyl phthalate) was included on the list due to its classification as toxic for reproduction (#Endocrine disrupting properties human health).

In the US, all four phthalates have been named among the EPA's 20 candidates to be designated a high priority for risk evaluation under Toxic Substances Control Act (TSCA).

DEHP, DBP, DIBP, and BBP are used to increase flexibility within plastics and can be found in a significant number of applications (e.g. flooring (and heavy wall covering), bags, balls for training and physical exercises, footwear, bathing equipment (swim-coats/wings/belts and pools - inflatable and others)).

Phthalates or phthalate esters (PE), are esters of phthalic acid. In general, they are substances with two carboxyl groups in the ortho position; there are those in which a linear alkyl group, a branched alkyl group, or a benzyl group is ester-bonded. The toxicity of PEs varies widely, depending on their side chains.

The toxic properties of the phthalates are linked to their molecular structure. It was concluded that PEs whose side chain length range from C4 to C6 induced similar severe reproductive effects in animals used for category approach analysis. Within the group of phthalate esters, the most potent reproductive toxicants are the di-n-hexyl and n-diethylhaxyl phthalates. As the side chain di-n-hexyl phthalate is lengthened to 8 carbons (di-octyl-) or shortened to 2 carbons (di-ethyl-), reproductive toxicity does not occur even at doses which cause body weight loss. Additionally, as the length of the n-alkyl substitution is shortened from 6 (di-n-hexyl), 5 (di-n-pentyl-), 4 (di-nbutyl-) or 3 (di-n-propyl-), there is a reduction in the potency of reproductive effects. Because of this, lower-molecular-weight phthalates (ie those derived from C3-C6 alcohols) are being gradually replaced in consumer products globally and replaced with high-molecular-weight phthalates (those with more than 6 carbons in their backbone, which gives them increased permanency and durability).

As legislative steps are now being taken in the area of endocrine disruption, there is an ever pressing need to research and understand more in this area. However, this is by no means a ‘quick win’.  In the case of phthalates, despite 60 years of research there is still a lack of understanding of the molecular action for this group of chemicals (Nepelska M., Odum J.,Munn S. 2017). Currently, two adverse outcome pathways (AOPs) have been developed for phthalates based on the data for male and female effects. The well-established downstream effects from these 2 AOPs are described in the AOP Knowledge base. There is, however, still uncertainty and lack of adequate scientific understanding to confirm or refute whether there is a molecular initiating event (MIE) for phthalates. (Nepelska M., Odum J.,Munn S. 2017).

The challenges ahead in the area of endocrine disrupting chemicals are complex, particularly because of the difficulty in evaluating the precise impact within disease in humans or other organisms.  They are also important from a human health and regulatory perspective. Cambridge Environmental Assessments has significant expertise in the area of ED and will be able to help you to navigate your way through the safety and regulatory requirements for your materials, products or technologies. If you have any questions regarding ED please contact our experts at CEA; Malgorzata.Nepelska@cea-res.co.uk and Theresa.Neely@cea-res.co.uk.

Learn more about our endocrine disruptor expertise.

 

FURTHER READING

https://echa.europa.eu/-/endocrine-disrupting-properties-to-be-added-for-four-phthalates-in-the-authorisation-list

https://echa.europa.eu/-/four-new-substances-added-to-the-candidate-list

https://www.liebertpub.com/doi/10.1089/aivt.2017.0004

https://aopwiki.org/aops/18

https://aopwiki.org/aops/7

https://www.ncbi.nlm.nih.gov/pubmed/11099647

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