SCCS/1415/11 27 NOAEL rows Safety conclusion

codes .................................... 7, s from temporary tattoos and clothing textiles. PPD is an extreme, Ethyl lauroyl arginate HCl

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1415/11.

Opinion Number

SCCS/1415/11

NOAEL Rows

Substances Covered

Substance(s) Covered

codes .................................... 7 s from temporary tattoos and clothing textiles. PPD is an extreme Ethyl lauroyl arginate HCl

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
codes .................................... 7 60372-77-2	NOAEL	0.4 %	oral	Regulatory source p.27 SCCS Opinion
codes .................................... 7 60372-77-2	NOAEL	26	rat oral chronic	Regulatory source p.26 SCCS Opinion
codes .................................... 7 60372-77-2	NOAEL	271 mg/kg bw/day	Not recorded	Regulatory source p.26 SCCS Opinion
codes .................................... 7 60372-77-2	NOAEL	271 mg/kg bw/day	dermal absorption rat oral chronic	SCCS Opinion p.26 SCCS Opinion
codes .................................... 7 60372-77-2	NOAEL	271 mg/kg bw/day	dermal absorption rat oral chronic	SCCS Opinion p.26 SCCS Opinion
codes .................................... 7 60372-77-2	NOAEL	271 mg/kg bw/day	dermal absorption rat oral chronic	SCCS Opinion p.26 SCCS Opinion
codes .................................... 7 60372-77-2	NOAEL	271 mg/kg bw/day	dermal absorption rat oral chronic	SCCS Opinion p.26 SCCS Opinion
codes .................................... 7 60372-77-2	dermal absorption	0.4 %	dermal absorption oral	Regulatory source p.26 SCCS Opinion
codes .................................... 7 60372-77-2	dermal absorption	271 mg/kg bw/day	dermal absorption rat oral chronic	Regulatory source p.26 SCCS Opinion
codes .................................... 7 60372-77-2	dermal absorption	271 mg/kg bw/d	dermal absorption oral	Regulatory source p.26 SCCS Opinion
codes .................................... 7 60372-77-2	dermal absorption	271 mg/kg bw/d	dermal absorption dermal	Regulatory source p.26 SCCS Opinion
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	1 %	rat oral	Regulatory source p.61 SCCS Opinion
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	1 %	rat oral	Regulatory source p.61 SCCS Opinion
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	1 %	rat oral	Regulatory source p.61 SCCS Opinion
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	1 %	rat oral	Regulatory source p.61 SCCS Opinion
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	1 %	rat oral	Regulatory source p.61 SCCS Opinion
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	1 %	rat oral	Regulatory source p.61 SCCS Opinion
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	6.45 mg/kg bw	rat oral	Regulatory source p.61 SCCS Opinion
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	6.45 mg/kg bw	rat oral	Regulatory source p.61 SCCS Opinion
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	1 %	NOAEL study rat oral	SCCS Opinion (Ref. 14, subm. V), p.61 SCCS Opinion
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	1 %	NOAEL study rat oral	SCCS Opinion (Ref. 14, subm. V), p.61 SCCS Opinion
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	1 %	NOAEL study rat oral	SCCS Opinion (Ref. 14, subm. V), p.61 SCCS Opinion
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	1 %	NOAEL study rat oral	SCCS Opinion (Ref. 14, subm. V), p.61 SCCS Opinion
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	6.45 mg/kg bw	NOAEL study rat oral	SCCS Opinion p.61 SCCS Opinion
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	6.45 mg/kg bw	NOAEL study rat oral	SCCS Opinion p.61 SCCS Opinion
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	6.45 mg/kg bw	NOAEL study rat oral	SCCS Opinion p.61 SCCS Opinion
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	6.45 mg/kg bw	NOAEL study rat oral	SCCS Opinion p.61 SCCS Opinion

Safety Conclusion

sccs_opinions Max 0.75% in toothpaste; 0.2% in mouthwash (proposed uses); systemic safety maintained at currently authorised use concentrations

The SCCS has revised the Margin of Safety calculation for ethyl lauroyl arginate HCl in cosmetics based on a new dermal absorption study and maintains its conclusion that there are no systemic safety concerns at the currently authorised use concentrations. [On oral-care use] The concern that in the general population, regular use of toothpaste and possible additional use of a mouthwash containing ethyl lauroyl arginate HCl could cause local mucosal irritation, was not addressed by the submitted studies.

Key concerns: Unresolved concern that regular toothpaste use plus mouthwash containing the substance could cause local mucosal irritation - not addressed by submitted studies; additional mucosal irritation data did not alter the earlier opinion.

Opinion date: 2011-06-21

Source Citation

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