Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

In view of its whole life cycle the substance is either processed under closed system technology or incorporated in polymer matrix when used in treated articles. The exposure situations for workers and consumers could be shown to be negligible low. With this the requirements for exposure based waiving are fulfilled.


Short description of key information:
test waived based on exposure consideration

Justification for selection of Effect on fertility via oral route:
During the whole life cycle exposure with the (solid) substance is very limited. Exposure with fine dust could only be expected after milling or during master batch processing. Both production steps are highly controlled industrial processes where the legal binding OEL for fine dust applies. Therefore exposure with the substance is considered to be very limited/avoided with adequate OC and RMM (LVE, gloves; during charging/discharging also personal respiratory protection). After preparation of the master batches, the substance is closely incorporated into a polymer matrix and inhalation exposure could no longer be expected.
No relevant secondary exposure is considered, as no wastewater results from manufacturing and processing of the substance. The process water of the manufacturing process will be totally recycled in a closed system.
During the whole life cycle of the substance and especially during use in technical plastic articles, the oral, dermal or inhalation exposure of workers could be avoided and no relevant exposure of consumers occurs, as the substance is embedded into a polymer matrix. The information one would obtain from a study for reproduction toxicity was considered to be not needed in order to determine the risk assigned. With view to animal welfare and to avoid unnecessary animal testing, particularly on mammals, it was therefore decided to abdicate such a study.

Effects on developmental toxicity

Description of key information
test waived based on exposure consideration
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

The substance is during its whole life cycle is either processed under closed system technology or later during its use incorporated in polymer matrix. The exposure situations for workers and consumers could be shown to be negligible low. With this the requirements for exposure based waiving according to REACH Directive 1907/2006/EU Annex IX, chapter 3, are fulfilled.


Justification for selection of Effect on developmental toxicity: via oral route:
During the whole life cycle exposure with the (solid) substance is very limited. Exposure with fine dust could only be expected after milling or during master batch processing. Both production steps are highly controlled industrial processes where the legal binding OEL for fine dust applies. Therefore exposure with the substance is considered to be very limited/avoided with adequate OC and RMM (LVE, gloves; during charging/discharging also personal respiratory protection). After preparation of the master batches, the substance is closely incorporated into a polymer matrix and inhalation exposure could no longer be expected.
No relevant secondary exposure is considered, as no wastewater results from manufacturing and processing of the substance. The process water of the manufacturing process will be totally recycled in a closed system.
During the whole life cycle of the substance and especially during use in technical plastic articles, the oral, dermal or inhalation exposure of workers could be avoided and no relevant exposure of consumers occurs, as the substance is embedded into a polymer matrix. The information one would obtain from a study for reproduction toxicity was considered to be not needed in order to determine the risk assigned. With view to animal welfare and to avoid unnecessary animal testing, particularly on mammals, it was therefore decided to abdicate such a study.

Justification for classification or non-classification

According to the GHS criteria, listed in Annex I, the substance does not have to be classified as a hazardous substance regarding reproductive toxicity.

Additional information