Chemical name: 1,2-Benzenedicarboxylic acid, bis(2-methylpropyl) 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 authorization requirement, e.g. uses as intermediates or for scientific research and development activities, as described in the document Generic exemptions from the authorization 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). However, this exemption is constrained by entry 51 of REACH Annex XVII, restricting its use in toys and childcare articles (individually or in any combination of the phthalates bis(2-ethylhexyl) phthalate (DEHP, EC No 204-211-0), benzyl butyl phthalate (BBP, EC No 201-622-7), dibutyl phthalate (DBP, EC No 201 -557-4)) in a concentration equal to or greater than 0.1 % (after 7 July 2020 this restriction will apply to any articles). 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 diisobutyl phthalate (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, diisobutyl phthalate 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 diisobutyl phthalate in Annex XIV has the effect that any use of this substance after 21/02/2015 (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 diisobutyl phthalate.

The reasons for the final regulatory action were relevant to: Human health

Summary of known hazards and risks to human health:

Diisobutyl phthalate has been classified under Regulation (EC) No 1272/2008 (CLP Regulation) as Toxic for Reproduction, Category 1B, H360Df ("May damage the unborn child. Suspected of damaging 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 repeated dose toxicity

Diisobutyl phthalate (and similarly also the monoester, mono-iso-butyl phthalate to which DIBP hydrolysed) induced microscopic testicular atrophy associated with markedly reduced testes weights in rats and alterations in zinc and testosterone concentrations in rats and mice after oral exposure.

Summary of data for toxicity for reproduction

Adverse effects on male reproductive organs (testicular toxicity) and on spermatogenesis had been observed at relatively high dosages during repeat dose toxicity studies (see above).

Studies related to developmental toxicity revealed embryotoxic, fetotoxic and teratogenic properties after oral administration or intraperitoneal injection of diisobutyl phthalate in pregnant rats. A LOAEL of 125 mg/kg bw/day was derived for developmental toxicity.

Expected effect of the final regulatory action in relation to human health:

Avoidance of risk for human health from the use of diisobutyl phthalate.

Date of entry into force of the final regulatory action: 21/02/2015