SCCS/1008/06 9 NOAEL rows Safety conclusion

Primary name, 4-Aminobenzoic acid (PABA)

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1008/06.

Opinion Number

SCCS/1008/06

NOAEL Rows

Substances Covered

Substance(s) Covered

Primary name 4-Aminobenzoic acid (PABA)

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
Primary name 150-13-0	NOAEL	0.1 %	rat oral 51-year	Regulatory source p.17 SCCS Opinion
Primary name 150-13-0	NOAEL	1 %	rat oral 5 weeks	Regulatory source p.17 SCCS Opinion
Primary name 150-13-0	NOAEL	108	oral 108 days	Regulatory source p.18 SCCS Opinion
Primary name 150-13-0	NOAEL	108	oral 108 days	Regulatory source p.18 SCCS Opinion
Primary name 150-13-0	NOAEL	1 %	NOAEL study rat oral 5 weeks	SCCS Opinion p.17 SCCS Opinion
Primary name 150-13-0	NOAEL	1 %	NOAEL study rat oral 5 weeks	SCCS Opinion p.17 SCCS Opinion
Primary name 150-13-0	NOAEL	1 %	NOAEL study rat oral 5 weeks	SCCS Opinion p.17 SCCS Opinion
Primary name 150-13-0	NOAEL	1 %	NOAEL study rat oral 5 weeks	SCCS Opinion p.17 SCCS Opinion
Primary name 150-13-0	repeated dose toxicity	100 mg/kg bw/d	repeated dose toxicity rat oral 2 weeks	Regulatory source p.47 SCCS Opinion

Safety Conclusion

sccs_opinions Max 5% (currently authorised maximum as UV filter; not re-confirmed)

Although 4-aminobenzoic acid is presently permitted and used as a sunscreen, it became apparent in the process of evaluation of the dossier that much of the information did not conform to current standards and guidelines. Before any further evaluation of the use of 4-aminobenzoic acid, both as a UV-filter and for purposes other than a UV filter, the SCCP requires a new dossier in which data to all relevant toxicological endpoints and conform to modern standards and SCCNFP/SCCP guidelines to be submitted before 1 July 2007.

Key concerns: Much of the dossier information did not conform to current standards and guidelines; a new dossier with data to all relevant toxicological endpoints required (deadline 1 July 2007); applicant must specify other intended purposes. Pharmaceutical-grade purity issues noted (specified 98.5%).

Opinion date: 2006-06-20

Source Citation

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