SCCS/1443/11 4 NOAEL rows Safety conclusion

s from temporary tattoos and clothing textiles. PPD is an extreme, p-Phenylenediamine

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1443/11.

Opinion Number

SCCS/1443/11

NOAEL Rows

Substances Covered

Substance(s) Covered

s from temporary tattoos and clothing textiles. PPD is an extreme p-Phenylenediamine

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	4 mg/kg bw/d	NOAEL study oral 90 days	SCCS Opinion p.59
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	4 mg/kg bw/d	NOAEL study oral 90 days	SCCS Opinion p.59
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	4 mg/kg bw/d	NOAEL study oral 90 days	SCCS Opinion p.59
s from temporary tattoos and clothing textiles. PPD is an extreme 106-50-3	NOAEL	4 mg/kg bw/d	NOAEL study oral 90 days	SCCS Opinion p.59

Safety Conclusion

sccs_opinions Max Dermal application safe regarding systemic effects (existing non-nano opinion stands at 10%); nano form: no concentration limit established pending genotoxicity data

insufficient data

Key concerns: Genotoxicity data insufficient for nano form; systemic effects via dermal route considered no concern; subsequent genotoxicity studies (submitted 2014) showed no mutagenic/clastogenic potential

Opinion date: 18 March 2013

Source Citation

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