On November 19, 2020, news provider ChemicalWatch reported in their weekly “ECHA round-up” that Norway recently submitted a Harmonized Classification and Labeling (CLH) proposal regarding the flame retardant chemical tetrabromobisphenol A (TBBPA) (CAS 79-94-7).
The substance has previously been found in food contact materials (FPF reported) and represents the most widely used brominated flame retardant (BFR) worldwide. BFRs are a group of chemicals that have been characterized as often being persistent, bioaccumulative, and toxic (PBT). Earlier this year, Australia had already classified this compound as a category 2 carcinogen (FPF reported).
So far TBBPA has only been listed as an acute and chronic hazard for aquatic environments under REACH. However, the substance has been under evaluation for PBT and endocrine disrupting (ED) properties as part of the EU’s Community rolling action plan (CoRAP). The Norwegian authorities submitted a proposal to the European Chemical Agency ECHA that collects information from recent scientific studies that it says justifies adding the classification “possibly carcinogenicity 2a”.
The base for the Norwegian argumentation is largely on findings of a two-year rodent study by The National Toxicology Program (NTP), which had revealed sufficient evidence for carcinogenicity and endocrine-disrupting effects. The authors report, among other findings, a positive correlation between exposure to TBBPA and uterine tumors in rats. These results indicate that TBBPA is probably also carcinogenic to humans (Lei et al, 2015). Furthermore, as mentioned in the proposal, uterine cancer is predicted to be one of the three most common cancer types in women by 2030, which emphasizes the necessity for adding the classification.
The proposal is still open for comments on (1) germ cell mutagenicity, (2) carcinogenicity, and (3) reproductive toxicity and specific target organ toxicity.
The deadline for comments is January 29, 2021.
Leigh Stringer (January 18, 2021). “TBBPA scrutiny having little impact on customer use, say flame retardant suppliers.” Chemical Watch
Grosse et al (April 2016). “Carcinogenicity of some industrial chemicals.” The Lancet Oncology
Dunnick et al (December 2014). “Environmental Chemical Exposure May Contribute to Uterine Cancer Development: Studies with Tetrabromobisphenol A.” Toxicologic Pathology
Lei et al (March 2015). “Tetrabromobisphenol A (TBBPA): Possible modes of action of toxicity and carcinogenicity in rodents.” Food and Chemical Toxicology
ECHA (September 19, 2020). “CLH report Proposal for Harmonised Classification and Labelling Based on Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2 International Chemical Identification: 2,2′,6,6′-tetrabromo-4,4′-isopropylidenediphenol; tetrabromobisphenol-A (TBBPA).” (pdf)
NTP (September 2014). “NTP Technical Report on the Toxicology Studies of Tetrabromobisphenol A (CASRN 79-94-7) in F344/NTac Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Tetrabromobisphenol A in Wistar Han [Crl:WI(Han)] Rats and B6C3F1/N Mice (Gavage Studies).” (pdf)