SCCS/1274/09 27 NOAEL rows Safety conclusion

(personal communication to, Citric acid (and) Silver citrate

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1274/09.

Opinion Number

SCCS/1274/09

NOAEL Rows

Substances Covered

Substance(s) Covered

(personal communication to Citric acid (and) Silver citrate

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
(personal communication to	NOAEL	0.00083 mg/kg bw/day	human 70 years	Regulatory source p.27 SCCS Opinion
(personal communication to	NOAEL	0.005 mg/kg bw/d	human	Regulatory source p.29 SCCS Opinion
(personal communication to	NOAEL	0.0065 mg/kg bw/day	human oral 70 years	Regulatory source p.27 SCCS Opinion
(personal communication to	NOAEL	0.0065 mg/kg bw/day	human oral 70 years	Regulatory source p.27 SCCS Opinion
(personal communication to	NOAEL	1	human	Regulatory source p.26 SCCS Opinion
(personal communication to	NOAEL	9	Not recorded	Regulatory source p.26 SCCS Opinion
(personal communication to	NOAEL	1000 mg/kg	rat dermal	Regulatory source p.21 SCCS Opinion
(personal communication to	NOAEL	1274	Not recorded	Regulatory source p.30 SCCS Opinion
(personal communication to	NOAEL	0.005 mg/kg bw/d	NOAEL study human	SCCS Opinion p.29 SCCS Opinion
(personal communication to	NOAEL	0.005 mg/kg bw/d	NOAEL study human	SCCS Opinion p.29 SCCS Opinion
(personal communication to	NOAEL	0.005 mg/kg bw/d	NOAEL study human	SCCS Opinion p.29 SCCS Opinion
(personal communication to	NOAEL	1274	NOAEL study	SCCS Opinion p.30 SCCS Opinion
(personal communication to	NOAEL	1274	NOAEL study	SCCS Opinion p.30 SCCS Opinion
(personal communication to	NOAEL	1274	NOAEL study	SCCS Opinion p.30 SCCS Opinion
(personal communication to	dermal absorption	0	dermal absorption dermal	Regulatory source p.5 SCCS Opinion
(personal communication to	dermal absorption	16.2 %	dermal absorption human dermal	Regulatory source p.29 SCCS Opinion
(personal communication to	dermal absorption	100 %	dermal absorption human dermal	Regulatory source p.29 SCCS Opinion
(personal communication to	dermal absorption	1000 mg/kg bw/day	dermal absorption oral 28 day	Regulatory source p.28 SCCS Opinion
(personal communication to	dermal absorption	1000 mg/kg bw/day	dermal absorption oral 28 day	Regulatory source p.28 SCCS Opinion
(personal communication to	dermal absorption	1000 mg/kg bw/day	dermal absorption oral 28 day	Regulatory source p.28 SCCS Opinion
(personal communication to	genotoxicity	300 mg/kg/day	genotoxicity	Regulatory source p.15 SCCS Opinion
(personal communication to	genotoxicity	300 mg/kg/day	genotoxicity	Regulatory source p.15 SCCS Opinion
(personal communication to	genotoxicity	1000 mg/kg/day	genotoxicity	Regulatory source p.15 SCCS Opinion
(personal communication to	irritation	1000 mg/kg/day	irritation rat oral 28-day	Regulatory source p.28 SCCS Opinion
(personal communication to	repeated dose toxicity	0.6 mg/kg bw/d	repeated dose toxicity rat oral sub-chronic	Regulatory source p.27 SCCS Opinion
(personal communication to	repeated dose toxicity	1000 mg/kg bw	repeated dose toxicity rat oral sub-chronic	Regulatory source p.27 SCCS Opinion
(personal communication to	repeated dose toxicity	1000 mg/kg bw	repeated dose toxicity rat oral sub-chronic	Regulatory source p.27 SCCS Opinion

Safety Conclusion

sccs_opinions Max 0.2%

On the basis of the data submitted, the use of citric acid (and) silver citrate in cosmetic products, at a concentration up to 0.2%, as a preservative does not pose a risk to the health of the consumer. Oral care products and products intended to be used in the vicinity of the eyes are excluded. For deodorants and anti-perspirants, it is also considered safe when used up to a total concentration of 0.2% as a preservative and/or an active ingredient.

Key concerns: Long-term effects of released silver, in particular argyria; available silver toxicity data very limited and old; SCCS strongly recommends an aggregate exposure assessment for silver from all sources (textiles, cleaning products, medical products).

Opinion date: 13 October 2009

Source Citation

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