SCCS/1416/11 53 NOAEL rows Safety conclusion

Kojic acid, codes.................................... 9, s are covered by this entry, with the

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1416/11.

Opinion Number

SCCS/1416/11

NOAEL Rows

Substances Covered

Substance(s) Covered

Kojic acid codes.................................... 9 s are covered by this entry, with the Picramic acid and sodium picramate (B28)

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
Kojic acid 501-30-4	NOAEL	2.38 µg/cm	genotoxicity human dermal	SCCS Opinion (Ref. 11), p.14 SCCS Opinion
Kojic acid 501-30-4	NOAEL	2.38 µg/cm	genotoxicity human dermal	SCCS Opinion (Ref. 11), p.14 SCCS Opinion
Kojic acid 501-30-4	NOAEL	2.38 µg/cm	genotoxicity human dermal	SCCS Opinion (Ref. 11), p.14 SCCS Opinion
Kojic acid 501-30-4	NOAEL	2.38 µg/cm	genotoxicity human dermal	SCCS Opinion (Ref. 11), p.14 SCCS Opinion
Kojic acid 501-30-4	genotoxicity	2.38 µg/cm	genotoxicity human dermal	Regulatory source p.14 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.0225 mg/kg bw/d	human oral	Regulatory source p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.166 mg/kg bw/d	human oral	Regulatory source p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.166 mg/kg bw/d	human oral	Regulatory source p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.166 mg /kg bw	human oral	Regulatory source p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.166 mg /kg bw	human oral	Regulatory source p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.166 mg /kg bw	human oral	Regulatory source p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.225 mg/kg bw/day	human oral	Regulatory source p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.83 mg/kg bw/d	human oral	Regulatory source p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.83 mg/kg bw/d	human oral	Regulatory source p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.83 mg /kg bw	human oral	Regulatory source p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.83 mg /kg bw	human oral	Regulatory source p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.9 mg/kg/d	human oral	Regulatory source p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.0225 mg/kg bw/d	NOAEL study human oral	SCCS Opinion p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.0225 mg/kg bw/d	NOAEL study human oral	SCCS Opinion p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.0225 mg/kg bw/d	NOAEL study human oral	SCCS Opinion p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.0225 mg/kg bw/d	NOAEL study human oral	SCCS Opinion p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.166 mg/kg bw/d	NOAEL study human oral	SCCS Opinion p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.166 mg/kg bw/d	NOAEL study human oral	SCCS Opinion p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.166 mg/kg bw/d	NOAEL study human oral	SCCS Opinion p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.166 mg/kg bw/d	NOAEL study human oral	SCCS Opinion p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.225 mg/kg bw/day	NOAEL study human oral	SCCS Opinion (Reference 44, sub III), p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.225 mg/kg bw/day	NOAEL study human oral	SCCS Opinion (Reference 44, sub III), p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.225 mg/kg bw/day	NOAEL study human oral	SCCS Opinion (Reference 44, sub III), p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.225 mg/kg bw/day	NOAEL study human oral	SCCS Opinion (Reference 44, sub III), p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.83 mg/kg bw/d	NOAEL study human oral	SCCS Opinion (Reference 44, sub III), p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.83 mg/kg bw/d	NOAEL study human oral	SCCS Opinion (Reference 44, sub III), p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.83 mg/kg bw/d	NOAEL study human oral	SCCS Opinion (Reference 44, sub III), p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.83 mg/kg bw/d	NOAEL study human oral	SCCS Opinion (Reference 44, sub III), p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.9 mg/kg/d	NOAEL study human oral	SCCS Opinion (Reference 44, sub III), p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.9 mg/kg/d	NOAEL study human oral	SCCS Opinion (Reference 44, sub III), p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.9 mg/kg/d	NOAEL study human oral	SCCS Opinion (Reference 44, sub III), p.90 SCCS Opinion
codes.................................... 9 1314-13-2	NOAEL	0.9 mg/kg/d	NOAEL study human oral	SCCS Opinion (Reference 44, sub III), p.90 SCCS Opinion
s are covered by this entry, with the	NOAEL	0.043 mg/kg bw/day	dermal absorption rat dermal 17 days	SCCS Opinion p.10 SCCS Opinion
s are covered by this entry, with the	NOAEL	0.043 mg/kg bw/day	dermal absorption rat dermal 17 days	SCCS Opinion p.10 SCCS Opinion
s are covered by this entry, with the	NOAEL	0.043 mg/kg bw/day	dermal absorption rat dermal 17 days	SCCS Opinion p.10 SCCS Opinion
s are covered by this entry, with the	dermal absorption	0.043 mg/kg bw/day	dermal absorption rat dermal 17 days	Regulatory source p.10 SCCS Opinion
s are covered by this entry, with the	dermal absorption	2 mg/kg bw/day	dermal absorption rat oral	Regulatory source p.10 SCCS Opinion
s are covered by this entry, with the	dermal absorption	2 mg/kg bw/day	dermal absorption rat oral 17 days	Regulatory source p.10 SCCS Opinion
s are covered by this entry, with the	dermal absorption	2 mg/kg bw/day	dermal absorption rat dermal 17 days	Regulatory source p.10 SCCS Opinion
s are covered by this entry, with the	dermal absorption	2 mg/kg	dermal absorption human oral	Regulatory source p.20 SCCS Opinion
s are covered by this entry, with the	dermal absorption	2 mg/kg bw/day	dermal absorption rat oral 17 d	Regulatory source p.20 SCCS Opinion
s are covered by this entry, with the	dermal absorption	2 mg/kg bw/day	dermal absorption rat oral 17 days	Regulatory source p.20 SCCS Opinion
s are covered by this entry, with the	reproductive toxicity	0.043 mg/kg bw/day	reproductive toxicity rat dermal 17 days	Regulatory source p.20 SCCS Opinion
s are covered by this entry, with the	reproductive toxicity	2 mg/kg bw/day	reproductive toxicity rat dermal 17 days	Regulatory source p.20 SCCS Opinion
Unnamed substance	NOAEL	1000 mg/kg/day	dermal absorption rat dermal	SCCS Opinion p.20 SCCS Opinion
Unnamed substance	NOAEL	1000 mg/kg/day	dermal absorption rat dermal	SCCS Opinion p.20 SCCS Opinion
Unnamed substance	NOAEL	1000 mg/kg/day	dermal absorption rat dermal	SCCS Opinion p.20 SCCS Opinion
Unnamed substance	dermal absorption	1000 mg/kg/day	dermal absorption rat dermal	Regulatory source p.20 SCCS Opinion

Safety Conclusion

sccs_opinions Max 0.6%

safe with restrictions

Key concerns: sensitisation not excluded; nitrosamine <50ppb; not with nitrosating agents

Opinion date: 14 December 2010

Source Citation

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