Reclassification of Augeo Clean Multi

Note: Since writing this blog, Solvay have reclassified the base as non-CMR although it is still a hazardous diffuser oil base

Many of you will have seen the news that Augeo Clean Multi has been reclassified. Below is a letter from Solvay explaining the reclassification. 

Self-classification: Updated toxicological information (AugeoⓇ Clean Multi | CAS 100-79-8)

Dear Customer

Solvay follows the principles of Responsible Care and is therefore keeping its customers updated with the latest relevant information on its products.
Solvay would like to inform you that following a tonnage band upgrade and subsequent decisions on the testing proposal by the European Chemical Agency (ECHA) under the framework of Regulation (EC) No 1907/2006 (REACH), Solvay (Rhodia Operations-1) as a Lead Registrant was required to perform a number of scientific studies regarding the substance 2,2-dimethyl-1,3-dioxolane-4-methanol (CAS 100-79-8), including a development study on rabbits (OECD 414).
As a result of this scientific OECD 414 study, adverse effects on development of the tested species were observed (at the highest dosage) for the first time. This has triggered:

● An additional SELF-CLASSIFICATION as Reprotox, cat 2 (H361d) - more details in Annex 1;
● The update of the REACH dossier on April 24th, 2023;
● The decision to perform additional mechanistic studies to clarify those results that were not observed before in other studies performed on different species (rats).

A further update of the REACH dossier is forecasted in 2024: classification might be revised based on the outcome of the additional mechanistic studies.
The classification change is solely a consequence of a new toxicity study completed on the substance itself, as required for EU REACH regulations. Further, the effects seen in this new study are only observed at relatively high doses via Oral route ( NOAEL for development toxicity : 300 mg/kg bw /day)
In the meantime, the Chemical Safety Report (CSR) has been updated on the basis of these effects and the most recent tonnage data. All uses currently covered in our REACH dossier and displayed in our most recent extended Safety Data Sheet are safe.
The Safety Data Sheets will include this new classification and, when applicable for the European Safety Data Sheet, an extended section covering the risk assessment conclusions. The quantity of 2,2-dimethyl-1,3-dioxolane-4-methanol (CAS 100-79-8) that is triggering a change in classification for a formulation varies based on the country regulation and should be reviewed case by case, with the company regulatory group.
For example: ≥ 3% is the general concentration limit for H361d in mixtures under EU CLP (EU).
≥ 0.1% is the classification threshold for H361d in mixtures under OSHA 2012 HCS (USA).