SCCS/1657/23 34 NOAEL rows Safety conclusion

Water-soluble zinc salts used in oral hygiene products - Submission II, water-soluble zinc salts used in oral hygiene

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1657/23.

Opinion Number

SCCS/1657/23

NOAEL Rows

Substances Covered

Substance(s) Covered

Water-soluble zinc salts used in oral hygiene products - Submission II water-soluble zinc salts used in oral hygiene

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
557-34-6 557-34-6	NOAEL	0.1 %	oral	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	0.43	oral	Regulatory source p.9 SCCS Opinion
557-34-6 557-34-6	NOAEL	0.43	oral	Regulatory source p.9 SCCS Opinion
557-34-6 557-34-6	NOAEL	1 %	oral	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	1 %	oral	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	6	oral 6 year	Regulatory source p.15 SCCS Opinion
557-34-6 557-34-6	NOAEL	10	Not recorded	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	10	Not recorded	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	10	Not recorded	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	16	Not recorded	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	16	Not recorded	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	16	Not recorded	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	17	oral	Regulatory source p.17 SCCS Opinion
557-34-6 557-34-6	NOAEL	24	Not recorded	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	24	Not recorded	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	24	Not recorded	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	24	Not recorded	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	37	Not recorded	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	37	Not recorded	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	37	Not recorded	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	37	Not recorded	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	50	Not recorded	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	50	Not recorded	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	50	Not recorded	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	53	Not recorded	Regulatory source p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	1657	oral	Regulatory source p.17 SCCS Opinion
557-34-6 557-34-6	NOAEL	1 %	NOAEL study oral	SCCS Opinion p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	1 %	NOAEL study oral	SCCS Opinion p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	1 %	NOAEL study oral	SCCS Opinion p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	1 %	NOAEL study oral	SCCS Opinion p.16 SCCS Opinion
557-34-6 557-34-6	NOAEL	1657	NOAEL study oral	SCCS Opinion p.17 SCCS Opinion
557-34-6 557-34-6	NOAEL	1657	NOAEL study oral	SCCS Opinion p.17 SCCS Opinion
557-34-6 557-34-6	NOAEL	1657	NOAEL study oral	SCCS Opinion p.17 SCCS Opinion
557-34-6 557-34-6	NOAEL	1657	NOAEL study oral	SCCS Opinion p.17 SCCS Opinion

Safety Conclusion

sccs_opinions Max 1% (as Zn) toothpaste (adults/children ≥1 yr); 0.72% toothpaste for children <1 yr; 0.1% mouthwash (age >6 years)

safe with restrictions

Key concerns: Aggregate exposure including diet must be considered; exceeds upper limit for children under 1 year at 1%

Opinion date: 26 October 2023

safety_opinions general Max 1

unknown

Opinion date: 26 October 2023

Source Citation

Primary source https://health.ec.europa.eu/scientific-committees/scientific-committee-consumer-safety-sccs/sccs-opinions_en