Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
exposure considerations
Justification for data waiving:
the study does not need to be conducted because relevant human exposure can be excluded as demonstrated in the relevant exposure assessment
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
A Chemical Safety Assessment was conducted following the principles of Annex I of the REACH Regulation, to estimate the exposure of Micromica to workers and consumers during the uses described in Section 3 of this dossier, and the risks associated with this exposure. This assessment can be found in Section 9 of the CSR attached to Section 13 of this dossier.

For workers potentially exposed to Micromica during formulation processes (Exposure Scenario 1), the individual RCRs were all below 0.1. Indeed, the combined RCR for all four processes and by the dermal and inhalation routes was 0.22, indicating a lack of relevant exposure to these workers even under these exaggerated, health-precautionary conditions.

Four processes were outlined for workers at industrial sites, for the production of cosmetics (Exposure Scenario 2) and the production of fillers, paints and lubricants (Exposure Scenario 3). In both cases, the individual RCRs were below 0.1, and the combined RCR (for all processes and by both routes of potential exposure) was 0.22. Again, this indicates a lack of relevant exposure, even under these health-precautionary conditions.

The final exposure scenario (Exposure Scenario 4) covers the consumer use of cosmetics containing Micromica. Two product types are antipicated; lipsticks and facial makeup (powder/foundation). For the former, the RCR for oral exposure (assuming the worst-case scenario that 100% of the applied lipstick is ingested) was 0.012; assuming the opposite (i.e. 100% dermal absorption) results in the same RCR (0.012). The RCR for the powder/foundation product type was 0.232 by the dermal route. No oral or inhalation exposure was anticipated for this product type. Even combining the RCRs for the two product types, producing an exaggerated, health-precautionary scenario, results in an RCR of 0.256, indicating that the estimated exposure is not toxicologically relevant.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Categories Display