SCCS/1514/13 71 NOAEL rows Safety conclusion

, or to derive a toxicological point of departure based, codes ............................................... 10, s are covered by this entry, with the

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1514/13.

Opinion Number

SCCS/1514/13

NOAEL Rows

Substances Covered

Substance(s) Covered

, or to derive a toxicological point of departure based codes ............................................... 10 s are covered by this entry, with the Parabens - propyl- and butylparaben (P82)

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
, or to derive a toxicological point of departure based 94-13-3	NOAEL	2 mg/kg/day	reproductive toxicity rat 394 days	SCCS Opinion p.23 SCCS Opinion
, or to derive a toxicological point of departure based 94-13-3	NOAEL	2 mg/kg/day	reproductive toxicity rat 394 days	SCCS Opinion p.23 SCCS Opinion
, or to derive a toxicological point of departure based 94-13-3	NOAEL	2 mg/kg/day	reproductive toxicity rat 394 days	SCCS Opinion p.23 SCCS Opinion
, or to derive a toxicological point of departure based 94-13-3	NOAEL	2 mg/kg/day	reproductive toxicity rat 394 days	SCCS Opinion p.23 SCCS Opinion
, or to derive a toxicological point of departure based 94-13-3	NOAEL	1000 mg/kg/day	reproductive toxicity rat 422 days	SCCS Opinion p.23 SCCS Opinion
, or to derive a toxicological point of departure based 94-13-3	NOAEL	1000 mg/kg/day	reproductive toxicity rat 422 days	SCCS Opinion p.23 SCCS Opinion
, or to derive a toxicological point of departure based 94-13-3	NOAEL	1000 mg/kg/day	reproductive toxicity rat 422 days	SCCS Opinion p.23 SCCS Opinion
, or to derive a toxicological point of departure based 94-13-3	NOAEL	1000 mg/kg/day	reproductive toxicity rat 422 days	SCCS Opinion p.23 SCCS Opinion
, or to derive a toxicological point of departure based 94-13-3	reproductive toxicity	2 mg/kg/day	reproductive toxicity rat 394 days	Regulatory source p.23 SCCS Opinion
, or to derive a toxicological point of departure based 94-13-3	reproductive toxicity	1000 mg/kg/day	reproductive toxicity rat 422 days	Regulatory source p.23 SCCS Opinion
, or to derive a toxicological point of departure based 94-13-3	reproductive toxicity	1000 mg/kg	reproductive toxicity rat	Regulatory source p.26 SCCS Opinion
, or to derive a toxicological point of departure based 94-13-3	reproductive toxicity	1000 mg/kg/day	reproductive toxicity rat	Regulatory source p.26 SCCS Opinion
codes ............................................... 10 94-26-8	NOAEL	2 mg/kg bw/day	repeated dose toxicity mouse oral	SCCS Opinion p.35 SCCS Opinion
codes ............................................... 10 94-26-8	NOAEL	2 mg/kg bw/day	repeated dose toxicity mouse oral	SCCS Opinion p.35 SCCS Opinion
codes ............................................... 10 94-26-8	NOAEL	2 mg/kg bw/day	repeated dose toxicity mouse oral	SCCS Opinion p.35 SCCS Opinion
codes ............................................... 10 94-26-8	NOAEL	2 mg/kg bw/day	repeated dose toxicity mouse oral	SCCS Opinion p.35 SCCS Opinion
codes ............................................... 10 94-26-8	repeated dose toxicity	2 mg/kg bw/day	repeated dose toxicity mouse oral	Regulatory source p.35 SCCS Opinion
codes ............................................... 10 94-26-8	repeated dose toxicity	2 mg/kg bw/day	repeated dose toxicity mouse oral	Regulatory source p.35 SCCS Opinion
codes ............................................... 10 94-26-8	repeated dose toxicity	2 mg/kg bw/day	repeated dose toxicity oral subchronic	Regulatory source p.35 SCCS Opinion
codes ............................................... 10 94-26-8	repeated dose toxicity	2 mg/kg bw/day	repeated dose toxicity oral subchronic	Regulatory source p.35 SCCS Opinion
codes ............................................... 10 94-26-8	reproductive toxicity	2 mg/kg bw/day	reproductive toxicity rat 17 days	Regulatory source p.41 SCCS Opinion
codes ............................................... 10 94-26-8	reproductive toxicity	2 mg/kg bw/day	reproductive toxicity rat oral	Regulatory source p.42 SCCS Opinion
codes ............................................... 10 94-26-8	reproductive toxicity	2 mg/kg bw/day	reproductive toxicity mouse oral	Regulatory source p.42 SCCS Opinion
codes ............................................... 10 94-26-8	reproductive toxicity	2 mg/kg bw/day	reproductive toxicity mouse oral developmental	Regulatory source p.42 SCCS Opinion
codes ............................................... 10 94-26-8	reproductive toxicity	2 mg/kg bw/day	reproductive toxicity mouse oral developmental	Regulatory source p.42 SCCS Opinion
s are covered by this entry, with the	NOAEL	2 mg/kg bw/day	rat	Regulatory source p.8 SCCS Opinion
s are covered by this entry, with the	NOAEL	2 mg/kg	oral	Regulatory source p.10 SCCS Opinion
s are covered by this entry, with the	NOAEL	3.5	rat	Regulatory source p.37 SCCS Opinion
s are covered by this entry, with the	NOAEL	4.36 mg/kg bw/day	rat	Regulatory source p.37 SCCS Opinion
s are covered by this entry, with the	NOAEL	11	Not recorded	Regulatory source p.11 SCCS Opinion
s are covered by this entry, with the	NOAEL	13	Not recorded	Regulatory source p.13 SCCS Opinion
s are covered by this entry, with the	NOAEL	1100 mg/kg bw/day	Not recorded	Regulatory source p.42 SCCS Opinion
s are covered by this entry, with the	NOAEL	1100 mg/kg bw/day	rat	Regulatory source p.42 SCCS Opinion
s are covered by this entry, with the	NOAEL	1514	human oral	Regulatory source p.13 SCCS Opinion
s are covered by this entry, with the	NOAEL	1514	oral 26-week	Regulatory source p.15 SCCS Opinion
s are covered by this entry, with the	NOAEL	10000 ppm	rat	Regulatory source p.42 SCCS Opinion
s are covered by this entry, with the	NOAEL	2 mg/kg	NOAEL study oral	SCCS Opinion p.10 SCCS Opinion
s are covered by this entry, with the	NOAEL	2 mg/kg	NOAEL study oral	SCCS Opinion p.10 SCCS Opinion
s are covered by this entry, with the	NOAEL	2 mg/kg	NOAEL study oral	SCCS Opinion p.10 SCCS Opinion
s are covered by this entry, with the	NOAEL	1514	NOAEL study human oral	SCCS Opinion p.13 SCCS Opinion
s are covered by this entry, with the	NOAEL	1514	NOAEL study human oral	SCCS Opinion p.13 SCCS Opinion
s are covered by this entry, with the	NOAEL	1514	NOAEL study human oral	SCCS Opinion p.13 SCCS Opinion
s are covered by this entry, with the	dermal absorption	0.0408 mg/kg bw/day	dermal absorption rat dermal 3 months	Regulatory source 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	0.19 %	dermal absorption dermal	Regulatory source p.11 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.6 SCCS Opinion
s are covered by this entry, with the	dermal absorption	2 mg/kg bw/day	dermal absorption rat dermal	Regulatory source p.8 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 bw/day	dermal absorption rat dermal 3 months	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	dermal absorption	3.7 %	dermal absorption dermal	Regulatory source p.12 SCCS Opinion
s are covered by this entry, with the	dermal absorption	3.7 %	dermal absorption human oral	Regulatory source p.20 SCCS Opinion
s are covered by this entry, with the	developmental toxicity	100 mg/kg/day	developmental toxicity rat oral Developmental	Regulatory source p.37 SCCS Opinion
s are covered by this entry, with the	developmental toxicity	1000 mg/kg/day	developmental toxicity rat oral Developmental	Regulatory source p.37 SCCS Opinion
s are covered by this entry, with the	developmental toxicity	1000 mg/kg bw/day	developmental toxicity rat oral Developmental	Regulatory source p.37 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	1	reproductive toxicity human dermal	Regulatory source p.8 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
s are covered by this entry, with the	reproductive toxicity	3.5	reproductive toxicity rat	Regulatory source p.37 SCCS Opinion
s are covered by this entry, with the	reproductive toxicity	14.4 mg/kg/day	reproductive toxicity rat oral 27 days	Regulatory source p.42 SCCS Opinion
s are covered by this entry, with the	reproductive toxicity	17	reproductive toxicity rat	Regulatory source p.6 SCCS Opinion
s are covered by this entry, with the	reproductive toxicity	1000 mg/kg bw/day	reproductive toxicity rat oral 8 weeks	Regulatory source p.16 SCCS Opinion
s are covered by this entry, with the	reproductive toxicity	1000 mg/kg bw/day	reproductive toxicity rat oral 4 weeks	Regulatory source p.21 SCCS Opinion
s are covered by this entry, with the	reproductive toxicity	1000 mg/kg	reproductive toxicity oral	Regulatory source p.23 SCCS Opinion
s are covered by this entry, with the	reproductive toxicity	1000 mg/kg/day	reproductive toxicity rat 27 days	Regulatory source p.42 SCCS Opinion
s are covered by this entry, with the	reproductive toxicity	1000 mg/kg/day	reproductive toxicity rat 27 days	Regulatory source p.42 SCCS Opinion
s are covered by this entry, with the	reproductive toxicity	1504 mg/kg/day	reproductive toxicity rat oral 27 days	Regulatory source p.42 SCCS Opinion

Safety Conclusion

sccs_opinions Max Combined ≤0.19%; propylparaben alone ≤0.14%

safe with restrictions

Key concerns: Potential endocrine modifying effects; endocrine-related reproductive toxicity concerns; toxicokinetics differ between rats and humans; SCCS reiterates previous conclusions pending improved exposure and toxicokinetics data

Opinion date: 3 May 2013

Source Citation

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