Echa's MSC Agrees on Immunotoxicity and Second Generation Eogrts for Melamine

Melamine should be tested on a second generation (F2) of rodents, as part of an extended one-generation study (Eogrts), according to Echa's Member State Committee. The committee accepted the testing proposal on the grounds of potential consumer and professional exposure to the chemical.

Although perhaps best known for its use in laminates such as Formica, the substance has a wide array of applications, including pigments, insulation, and fire-retardant additives in plastics, paints and paper.

A basic Eogrts only tests one generation of rodents for reproductive toxicity but there are case-by-case triggers for extending to an F2 generation, according to Echa guidance. One such trigger is significant consumer and/or professional exposure to a chemical, together with toxicity concerns.

Some registrants mistakenly assume that this relates solely to direct intended exposure, said MSC chair Watze de Wolf. However, it also covers indirect or unintended chemical exposure, such as leaching from products.

"Based on the information in the registration dossier, we did have indications of potential consumer/professional uses [of melamine-containing products] where there may be significant exposure," said Dr de Wolf.

Developmental immunotoxicity
The MSC also accepted a member state's proposal for amendment (pfa) to include an Eogrts cohort to test melamine for developmental immunotoxicity (DIT). The pfa, supported by the registrant, is based on recent scientific studies suggesting that the substance may be immunotoxic.

Concerns over this first came to light following a milk scandal in China in 2008. Some unscrupulous producers added the substance to powdered milk and baby formula to elevate nitrogen levels, thus providing falsely high protein test levels. Screening of exposed children later revealed that some showed signs of possible immune effects.

In 2016, an Egyptian study by a team from Zagazig University suggested that mice exposed to melamine showed such effects, including a decrease in a subtype of white blood cells called lymphocytes.

In August 2017, US research NGO TEDX (The Endocrine Disruption Exchange) called for research into whether exposure could affect memory and learning.

Eogrts for organotin

Meanwhile, during a compliance check, the MSC decided against an Eogrts F2 study for an organotin compound, based on exposure information: 2-ethylhexyl 10-ethyl-4-[[2-ethylhexyl)oxy]-2-oxoethyl]thio]-4]methyl-7-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate.

Organotin compounds are among the chemical groups targeted by NGO Greenpeace's Detox campaign. Signatories to the campaign include retailers Aldi, Coop, Lidl, Marks & Spencer, Primark and Tesco.