Chemical name: Phosphoric acid, tris(2-chloroethyl) ester Final regulatory action has been taken for the category: Industrial Final regulatory action: The chemical is Severely Restricted Use or uses prohibited by the final regulatory action: Industrial chemical. Use or uses that remain allowed: Pursuant to Regulation (EC) No 1907/2006 (REACH Regulation), only certain uses are exempted from the authorisation requirement, e.g. uses as intermediates or for scientific research and development activities, as described in the document Generic exemptions from the authorisation requirement. The exemption concerning mixtures mentioned in Section 1 of the linked document applies when the substance is present in mixtures below 0.3% (weight/weight) (generic concentration limit specified in Regulation (EC) No 1272/2008). From the exemptions specific to certain intrinsic properties mentioned in Section 2, those referring to Article 57 (c) and to hazards to human health apply for TCEP (see Section 2.4.2.1 below for intrinsic properties of the substance). The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: By Commission Regulation (EU) No 125/2012 of 14 February 2012 amending Annex XIV to Regulation (EC) No 1907/2006, tris(2-chloroethyl) phosphate (TCEP) was included into Annex XIV (Authorisation List) of Regulation (EC) No 1907/2006 (REACH Regulation), which contains substances of very high concern that are subject to authorisation. The listing of TCEP in Annex XIV has the effect that any use of this substance after 21/08/2015 (the Sunset Date) is prohibited (except for exempted uses as described in Section 2.3.2 of this document), unless a company submits an application for authorisation and the authorisation is granted. Since no applications for authorisation have been submitted to date only the exempted uses remain allowed. Hence, the final regulatory action severely restricts the use of tris(2-chloroethyl) phosphate. The reasons for the final regulatory action were relevant to: Human health Summary of known hazards and risks to human health: TCEP has been classified under Regulation (EC) No 1272/2008 (CLP Regulation) as Toxic for Reproduction, Category 1 B, H360F ("May damage fertility."), which is the basis for the identification as substance of very high concern under Article 57 (c) of Regulation (EC) No 1907/2006 (REACH Regulation). Summary of data for toxicity for reproduction Treatment of mice resulted in significant impairment of reproductive success of both sexes and of male reproductive organs and of sperm parameters. Oral administration of TCEP revealed significant impairment of reproductive capacity and fertility for both sexes during continuous breeding and for two successive generations in CD1- mice. The reproductive system of male mice appeared to be more sensitive to TCEP treatment than that of females. A significant reduction of the number of litters produced by the F0 generation, reduced pregnancy and fertility indices in the F1 generation, and reduced litter size in F0 and F1 generation. NOAEL fertility of 175 mg/kg bw/day was derived. Expected effect of the final regulatory action in relation to human health: Avoidance of risk for the human health from the use of Tris(2-chloroethyl) phosphate. Date of entry into force of the final regulatory action: 21/08/2015 |