SCCS/1511/13 20 NOAEL rows Safety conclusion

Lawsonia inermis (Henna), Lawsonia inermis (Henna) (C169)

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1511/13.

Opinion Number

SCCS/1511/13

NOAEL Rows

Substances Covered

Substance(s) Covered

Lawsonia inermis (Henna) Lawsonia inermis (Henna) (C169)

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
Lawsonia inermis (Henna) 84988-66-9	NOAEL	200 mg/kg/day	rat	Regulatory source p.35 SCCS Opinion
Lawsonia inermis (Henna) 84988-66-9	NOAEL	200 mg/kg bw/day	irritation rat oral 13 week	SCCS Opinion p.38 SCCS Opinion
Lawsonia inermis (Henna) 84988-66-9	NOAEL	200 mg/kg bw/day	irritation rat oral 13 week	SCCS Opinion p.38 SCCS Opinion
Lawsonia inermis (Henna) 84988-66-9	NOAEL	200 mg/kg bw/day	irritation rat oral 13 week	SCCS Opinion p.38 SCCS Opinion
Lawsonia inermis (Henna) 84988-66-9	NOAEL	200 mg/kg bw/day	irritation rat oral 13 week	SCCS Opinion p.38 SCCS Opinion
Lawsonia inermis (Henna) 84988-66-9	NOAEL	>2000 mg/kg bw	irritation rat oral 13 week	SCCS Opinion p.38 SCCS Opinion
Lawsonia inermis (Henna) 84988-66-9	NOAEL	>2000 mg/kg bw	irritation rat oral 13 week	SCCS Opinion p.38 SCCS Opinion
Lawsonia inermis (Henna) 84988-66-9	NOAEL	>2000 mg/kg bw	irritation rat oral 13 week	SCCS Opinion p.38 SCCS Opinion
Lawsonia inermis (Henna) 84988-66-9	NOAEL	>2000 mg/kg bw	irritation rat oral 13 week	SCCS Opinion p.38 SCCS Opinion
Lawsonia inermis (Henna) 84988-66-9	dermal absorption	0.00833 mg/kg bw/d	dermal absorption dermal	Regulatory source p.37 SCCS Opinion
Lawsonia inermis (Henna) 84988-66-9	dermal absorption	2 mg/kg bw/d	dermal absorption dermal	Regulatory source p.4 SCCS Opinion
Lawsonia inermis (Henna) 84988-66-9	dermal absorption	2 mg/kg bw/d	dermal absorption dermal	Regulatory source p.37 SCCS Opinion
Lawsonia inermis (Henna) 84988-66-9	dermal absorption	2 mg/kg bw/d	dermal absorption dermal	Regulatory source p.37 SCCS Opinion
Lawsonia inermis (Henna) 84988-66-9	genotoxicity	2 mg/kg bw/d	genotoxicity rat oral 90-day	Regulatory source p.22 SCCS Opinion
Lawsonia inermis (Henna) 84988-66-9	genotoxicity	2 mg/kg bw/d	genotoxicity rat oral 90-day	Regulatory source p.22 SCCS Opinion
Lawsonia inermis (Henna) 84988-66-9	genotoxicity	7 mg/kg bw	genotoxicity rat oral 90-day	Regulatory source p.22 SCCS Opinion
Lawsonia inermis (Henna) 84988-66-9	genotoxicity	40 mg/kg bw/day	genotoxicity rat oral 90-day	Regulatory source p.22 SCCS Opinion
Lawsonia inermis (Henna) 84988-66-9	genotoxicity	40 mg/kg bw/day	genotoxicity rat oral 90-day	Regulatory source p.22 SCCS Opinion
Lawsonia inermis (Henna) 84988-66-9	irritation	200 mg/kg bw/day	irritation rat oral 13 week	Regulatory source p.38 SCCS Opinion
Lawsonia inermis (Henna) 84988-66-9	irritation	>2000 mg/kg bw	irritation rat oral 13 week	Regulatory source p.38 SCCS Opinion

Safety Conclusion

sccs_opinions Max 20% powder (max 1.4% lawsone)

safe

Key concerns: weak sensitisation; genotoxicity of lawsone

Opinion date: 19 September 2013

Source Citation

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