Registration Dossier
Registration Dossier
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EC number: 237-149-8 | CAS number: 13669-76-6
Endpoint summary
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
No experimental study with the boron trifluoride phosphoric acid complex is available. With regard to the dissociation products of the complex (see IUCLID chapter 7.1), no systemic health hazard is expected when getting in contact with phosphoric acid as phosphoric acid and phosphates are widely present in the human body. BF3 dihydrate, when tested in a 90-day inhalation study (Rusch et al., 1986; see IUCLID chapter 7.5.2), did not cause effects on the reproductive organs of rats. The test substance is intended for use in an industrial setting only, and thus oral uptake is not an anticipated route of exposure. Upon hydrolysis of the test substance, boron trifluoride and phosphoric acid are formed among other dissociation products. The test substance itself and its direct hydrolysis products are highly corrosive and would lead to severe parental toxicity well before internal doses of the hydrolysis products are reached that could potentially cause effects on fertility or development. This would also result in unwarranted distress for the animals. Therefore, any reproductive study with the test substance is scientifically unjustified. Due to the corrosive properties of the substance, suitable risk management measures for dermal and inhalative exposure need to be taken (gloves, respiratory protection). Relevant human exposure via oral, dermal and inhalative uptake can be excluded, which justifies waiving of developmental toxicity and teratogenicity testing according to annex XI, section 3 of Regulation (EC) 1907/2006 (REACH).
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The substance does not need to be classified and labelled for reproductive toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EC.
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The substance does not need to be classified and labelled for reproductive toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation EC No 605/2014.
Additional information
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