SCCS/1413/11 122 NOAEL rows Safety conclusion

codes.................................... 7, N-Methyl-2-pyrrolidone (NMP)

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1413/11.

Opinion Number

SCCS/1413/11

NOAEL Rows

122

Substances Covered

Substance(s) Covered

codes.................................... 7 N-Methyl-2-pyrrolidone (NMP)

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
codes.................................... 7 872-50-4	NOAEL	28	Not recorded	Regulatory source p.28 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	29	Not recorded	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	40 %	rabbit dermal	Regulatory source p.28 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	48 mg/kg bw/day	rabbit inhalation	Regulatory source p.31 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	169 mg/kg bw/day	mouse oral 90 days	Regulatory source p.15 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	169 mg/kg bw/day	rat dermal 4-week	Regulatory source p.17 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	207 mg/kg bw/day	mouse oral chronic	Regulatory source p.19 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	250 mg/kg bw/day	rat oral 5 days	Regulatory source p.16 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	277 mg/kg bw/day	dog oral 90 days	Regulatory source p.16 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	429 mg/kg bw/day	mouse oral 28 days	Regulatory source p.14 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	600 mg/kg bw/day	rabbit dermal	Regulatory source p.28 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	2060 mg/kg bw/day	rat oral 28 days	Regulatory source p.13 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	7500 mg/kg	rat inhalation 5 days	Regulatory source p.14 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	48 mg/kg bw/day	NOAEL study rabbit inhalation	SCCS Opinion p.31 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	48 mg/kg bw/day	NOAEL study rabbit inhalation	SCCS Opinion p.31 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	48 mg/kg bw/day	NOAEL study rabbit inhalation	SCCS Opinion p.31 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	48 mg/kg bw/day	NOAEL study rabbit inhalation	SCCS Opinion p.31 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	160 mg/kg bw/day	developmental toxicity rat oral developmental	SCCS Opinion p.22 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	160 mg/kg bw/day	developmental toxicity rat oral developmental	SCCS Opinion p.22 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	160 mg/kg bw/day	developmental toxicity rat oral developmental	SCCS Opinion p.22 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	160 mg/kg bw/day	developmental toxicity rat oral developmental	SCCS Opinion p.22 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	332 mg/kg bw/day	developmental toxicity rat developmental	SCCS Opinion p.29 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	332 mg/kg bw/day	developmental toxicity rat developmental	SCCS Opinion p.29 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	332 mg/kg bw/day	developmental toxicity rat developmental	SCCS Opinion p.29 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	332 mg/kg bw/day	developmental toxicity rat developmental	SCCS Opinion p.29 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	429 mg/kg bw/day	NOAEL study mouse oral 28 days	SCCS Opinion p.14 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	429 mg/kg bw/day	NOAEL study mouse oral 28 days	SCCS Opinion p.14 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	429 mg/kg bw/day	NOAEL study mouse oral 28 days	SCCS Opinion p.14 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	429 mg/kg bw/day	NOAEL study mouse oral 28 days	SCCS Opinion p.14 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	630 mg/kg bw/day	developmental toxicity mouse inhalation developmental	SCCS Opinion p.30 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	630 mg/kg bw/day	developmental toxicity mouse inhalation developmental	SCCS Opinion p.30 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	630 mg/kg bw/day	developmental toxicity mouse inhalation developmental	SCCS Opinion p.30 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	630 mg/kg bw/day	developmental toxicity mouse inhalation developmental	SCCS Opinion p.30 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	750 mg/kg bw/day	developmental toxicity rat oral developmental	SCCS Opinion p.27 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	750 mg/kg bw/day	developmental toxicity rat oral developmental	SCCS Opinion p.27 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	750 mg/kg bw/day	developmental toxicity rat oral developmental	SCCS Opinion p.27 SCCS Opinion
codes.................................... 7 872-50-4	NOAEL	750 mg/kg bw/day	developmental toxicity rat oral developmental	SCCS Opinion p.27 SCCS Opinion
codes.................................... 7 872-50-4	carcinogenicity	169 mg/kg bw/day	carcinogenicity rat dermal 4-week	Regulatory source p.17 SCCS Opinion
codes.................................... 7 872-50-4	carcinogenicity	250 mg/kg bw/day	carcinogenicity rat inhalation 90-day	Regulatory source p.17 SCCS Opinion
codes.................................... 7 872-50-4	carcinogenicity	250 mg/kg bw/day	carcinogenicity rat inhalation 90-day	Regulatory source p.17 SCCS Opinion
codes.................................... 7 872-50-4	carcinogenicity	277 mg/kg bw/day	carcinogenicity rat dermal 90-day	Regulatory source p.17 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	1	developmental toxicity rabbit developmental	Regulatory source p.30 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	1	developmental toxicity developmental	Regulatory source p.30 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	2	developmental toxicity developmental	Regulatory source p.30 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	2	developmental toxicity developmental	Regulatory source p.30 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	2	developmental toxicity developmental	Regulatory source p.30 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	4	developmental toxicity rat inhalation Developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	6	developmental toxicity rat inhalation developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	6	developmental toxicity rat inhalation 3 days	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	14.8 mg/kg bw/day	developmental toxicity rat oral developmental	Regulatory source p.34 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	29	developmental toxicity rat inhalation developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	29	developmental toxicity rat inhalation developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	29	developmental toxicity rat inhalation developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	29	developmental toxicity rat inhalation developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	40 %	developmental toxicity rabbit dermal developmental	Regulatory source p.28 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	45	developmental toxicity rat inhalation developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	55 mg/kg bw/day	developmental toxicity rat oral developmental	Regulatory source p.26 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	55 mg/kg bw/day	developmental toxicity rat oral Developmental	Regulatory source p.26 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	55 mg/kg bw/day	developmental toxicity rabbit developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	74 mg/kg	developmental toxicity developmental	Regulatory source p.30 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	125 mg/kg bw/day	developmental toxicity rat inhalation developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	125 mg/kg bw/day	developmental toxicity rat oral developmental	Regulatory source p.30 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	125 mg/kg bw/day	developmental toxicity rat oral developmental	Regulatory source p.34 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	125 mg/kg bw/day	developmental toxicity rat oral developmental	Regulatory source p.36 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	125 mg/kg bw/day	developmental toxicity rat oral developmental	Regulatory source p.36 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	125 mg/kg bw/day	developmental toxicity rat oral developmental	Regulatory source p.28 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	160 mg/kg bw/day	developmental toxicity rat oral developmental	Regulatory source p.22 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	237 mg/kg bw/day	developmental toxicity rabbit dermal developmental	Regulatory source p.23 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	237 mg/kg bw/day	developmental toxicity rabbit dermal developmental	Regulatory source p.23 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	237 mg/kg bw/day	developmental toxicity rat oral developmental	Regulatory source p.28 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	237 mg/kg bw/day	developmental toxicity rat oral developmental	Regulatory source p.28 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	237 mg/kg bw/day	developmental toxicity rat dermal developmental	Regulatory source p.28 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	247	developmental toxicity rat inhalation developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	250 mg/kg bw/day	developmental toxicity rat developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	250 mg/kg bw/day	developmental toxicity rat developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	300 mg/kg bw/day	developmental toxicity rat inhalation developmental	Regulatory source p.24 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	300 mg/kg bw/day	developmental toxicity rabbit dermal developmental	Regulatory source p.28 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	332 mg/kg bw/day	developmental toxicity rat developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	332 mg/kg bw/day	developmental toxicity rat developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	360	developmental toxicity rat inhalation developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	400 mg/kg bw	developmental toxicity rabbit Developmental	Regulatory source p.26 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	494	developmental toxicity rat inhalation developmental	Regulatory source p.25 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	500 mg/kg bw/day	developmental toxicity rat dermal developmental	Regulatory source p.28 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	500	developmental toxicity developmental	Regulatory source p.30 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	622	developmental toxicity rat inhalation developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	630 mg/kg bw/day	developmental toxicity mouse inhalation developmental	Regulatory source p.30 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	630 mg/kg	developmental toxicity developmental	Regulatory source p.30 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	680	developmental toxicity rat inhalation developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	680	developmental toxicity rat inhalation developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	developmental toxicity	750 mg/kg bw/day	developmental toxicity rat oral developmental	Regulatory source p.27 SCCS Opinion
codes.................................... 7 872-50-4	repeated dose toxicity	169 mg/kg bw/day	repeated dose toxicity rat oral 90-day	Regulatory source p.35 SCCS Opinion
codes.................................... 7 872-50-4	repeated dose toxicity	250 mg/kg bw/day	repeated dose toxicity rat oral 90-day	Regulatory source p.35 SCCS Opinion
codes.................................... 7 872-50-4	repeated dose toxicity	250 mg/kg bw/day	repeated dose toxicity rat oral 90-day	Regulatory source p.35 SCCS Opinion
codes.................................... 7 872-50-4	repeated dose toxicity	277 mg/kg bw/day	repeated dose toxicity rat oral 90-day	Regulatory source p.35 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	2	reproductive toxicity rat oral developmental	Regulatory source p.30 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	2	reproductive toxicity rat oral developmental	Regulatory source p.30 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	11 %	reproductive toxicity rat inhalation developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	11 %	reproductive toxicity rat inhalation Developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	11 %	reproductive toxicity rat inhalation 7 days	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	11 %	reproductive toxicity rat inhalation 7 days	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	29	reproductive toxicity rat inhalation 7 days	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	48 mg/kg bw/day	reproductive toxicity rabbit dermal developmental	Regulatory source p.34 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	48 mg/kg bw/day	reproductive toxicity rabbit dermal developmental	Regulatory source p.34 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	48 mg/kg bw/day	reproductive toxicity rabbit dermal developmental	Regulatory source p.34 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	55 mg/kg bw/day	reproductive toxicity rat inhalation Developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	61	reproductive toxicity developmental	Regulatory source p.30 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	125 mg/kg bw/day	reproductive toxicity rat oral Developmental	Regulatory source p.28 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	125 mg/kg bw/day	reproductive toxicity rat oral developmental	Regulatory source p.30 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	125 mg/kg bw/day	reproductive toxicity rat oral developmental	Regulatory source p.30 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	160 mg/kg bw/day	reproductive toxicity rat oral Developmental	Regulatory source p.28 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	160 mg/kg bw/day	reproductive toxicity rat 10 days	Regulatory source p.28 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	175 mg/kg bw/day	reproductive toxicity rat inhalation Developmental	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	300 mg/kg bw/day	reproductive toxicity rat oral developmental	Regulatory source p.28 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	350 mg/kg bw/day	reproductive toxicity rat oral developmental	Regulatory source p.21 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	350 mg/kg bw/day	reproductive toxicity rat oral developmental	Regulatory source p.28 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	350 mg/kg bw/day	reproductive toxicity rat Developmental	Regulatory source p.28 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	500 mg/kg bw/day	reproductive toxicity developmental	Regulatory source p.22 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	500 mg/kg bw/day	reproductive toxicity rat dermal developmental	Regulatory source p.28 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	500 mg/kg bw/day	reproductive toxicity rat dermal developmental	Regulatory source p.28 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	600 mg/kg bw/day	reproductive toxicity rat oral Developmental	Regulatory source p.28 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	618	reproductive toxicity rat inhalation 7 days	Regulatory source p.29 SCCS Opinion
codes.................................... 7 872-50-4	reproductive toxicity	1995	reproductive toxicity rat inhalation 7 days	Regulatory source p.29 SCCS Opinion

Safety Conclusion

sccs_opinions Max 5% (assessed worst-case; found NOT safe)

Based on a worst case assessment with a maximum use concentration of 5% NMP in cosmetic products and a dermal absorption of 100%, the Margin of Safety is considered to be too low. ... With the information available at the time of assessment, the SCCS is of the opinion that the presence of NMP with a maximum use concentration of 5% in cosmetic products is not safe for the consumer. A re-evaluation may be possible should relevant data that addresses the above be provided.

Key concerns: At 5% with 100% dermal absorption the Margin of Safety is too low. Lack of data on actual maximum concentrations in cosmetic products and on dermal absorption at relevant concentrations. Re-evaluation possible if relevant data provided. NMP is a CMR-flagged substance (reproductive concern context).

Opinion date: 2011-03-22

Source Citation

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