Registration Dossier

Diss Factsheets

Administrative data

Description of key information

According to regulation (EC) 1907/2006, Art. 10 and 12 in conjunction with Annex X, Section 8.9.1 a carcinogenicity study is not required for the tonnage band of 100 -1000 tons per year.

Further, metallic boron is void of (i) any toxic effects in acute and 28 -day repeated dose toxicity studies up to limit doses, (ii) local irritating effects in skin and eye irritation tests and (iii) genetic toxicity in three different in vitro test systems. Based on the above mentioned information and the assumed inertness based on its practically negligible water solubility and bioaccessibility in artificial body fluids, it is not scientifically plausible to assume any carcinogenic potential for this substance.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Elemental boron is void of (i) any toxic effects in acute and 28 -day repeated dose toxicity studies up to limit doses, (ii) local irritating effects in skin and eye irritation tests and (iii) genetic toxicity in three different in vitro test systems. Based on the above mentioned information and the assumed inertness based on its practically negligible water solubility and bioaccessibility in artificial body fluids, it is not scientifically plausible to assume any carcinogenic potential for this substance. No hazard classification is required.

Additional information

Categories Display