SCCS/1543/14 21 NOAEL rows Safety conclusion

codes............................................7, Ethyl lauroyl arginate HCl - Addendum

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1543/14.

Opinion Number

SCCS/1543/14

NOAEL Rows

Substances Covered

Substance(s) Covered

codes............................................7 Ethyl lauroyl arginate HCl - Addendum

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
codes............................................7 60372-77-2	NOAEL	0.442 mg/kg bw/day	oral 9 years	Regulatory source p.18 SCCS Opinion
codes............................................7 60372-77-2	NOAEL	0.442 mg/kg bw/day	oral 3 year	Regulatory source p.20 SCCS Opinion
codes............................................7 60372-77-2	NOAEL	6	oral 28 day	Regulatory source p.12 SCCS Opinion
codes............................................7 60372-77-2	NOAEL	6	oral	Regulatory source p.12 SCCS Opinion
codes............................................7 60372-77-2	NOAEL	6	oral	Regulatory source p.12 SCCS Opinion
codes............................................7 60372-77-2	NOAEL	56 mg/kg bw/day	rat oral 13-week	Regulatory source p.18 SCCS Opinion
codes............................................7 60372-77-2	NOAEL	56 mg/kg bw/day	rat oral 13-week	Regulatory source p.20 SCCS Opinion
codes............................................7 60372-77-2	NOAEL	95	dermal	Regulatory source p.20 SCCS Opinion
codes............................................7 60372-77-2	NOAEL	183	oral	Regulatory source p.12 SCCS Opinion
codes............................................7 60372-77-2	NOAEL	271 mg/kg bw/day	rat oral 13-week	Regulatory source p.18 SCCS Opinion
codes............................................7 60372-77-2	NOAEL	271 mg/kg bw/day	rat oral 13-week	Regulatory source p.20 SCCS Opinion
codes............................................7 60372-77-2	NOAEL	346	oral chronic	Regulatory source p.12 SCCS Opinion
codes............................................7 60372-77-2	NOAEL	271 mg/kg bw/day	repeated dose toxicity rat Chronic	SCCS Opinion p.13 SCCS Opinion
codes............................................7 60372-77-2	NOAEL	271 mg/kg bw/day	repeated dose toxicity rat Chronic	SCCS Opinion p.13 SCCS Opinion
codes............................................7 60372-77-2	NOAEL	271 mg/kg bw/day	repeated dose toxicity rat Chronic	SCCS Opinion p.13 SCCS Opinion
codes............................................7 60372-77-2	NOAEL	271 mg/kg bw/day	repeated dose toxicity rat Chronic	SCCS Opinion p.13 SCCS Opinion
codes............................................7 60372-77-2	repeated dose toxicity	0.8 %	repeated dose toxicity oral 28 day	Regulatory source p.12 SCCS Opinion
codes............................................7 60372-77-2	repeated dose toxicity	0.8 %	repeated dose toxicity oral 28 day	Regulatory source p.12 SCCS Opinion
codes............................................7 60372-77-2	repeated dose toxicity	0.8 %	repeated dose toxicity oral 28 day	Regulatory source p.12 SCCS Opinion
codes............................................7 60372-77-2	repeated dose toxicity	271 mg/kg bw/day	repeated dose toxicity rat Chronic	Regulatory source p.13 SCCS Opinion
codes............................................7 60372-77-2	reproductive toxicity	207 mg/kg bw/day	reproductive toxicity rat chronic	Regulatory source p.13 SCCS Opinion

Safety Conclusion

sccs_opinions Max Oral products (toothpaste) 0.15%; cosmetic products generally at previously established limits

safe with restrictions

Key concerns: Antimicrobial preservative; oral exposure concerns; previous opinion confirmed with addendum

Opinion date: 25 March 2015

Source Citation

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