SCCS/0666/03 2 NOAEL rows Safety conclusion

Hydroxyethyl-p-phenylenediamine sulfate (INCI), Hydroxyethyl-p-phenylenediamine Sulfate

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/0666/03.

Opinion Number
SCCS/0666/03
NOAEL Rows
2
Substances Covered
2

Substance(s) Covered

Hydroxyethyl-p-phenylenediamine sulfate (INCI) Hydroxyethyl-p-phenylenediamine Sulfate

NOAEL Values Extracted from This Opinion

Substance Endpoint Value Study Source
Hydroxyethyl-p-phenylenediamine sulfate (INCI)
93841-25-9
 NOAEL 25 mg/kg bw rat
oral
90 days
Regulatory source
p.10
SCCS Opinion
Hydroxyethyl-p-phenylenediamine sulfate (INCI)
93841-25-9
 repeated dose toxicity 25 mg/kg bw/day repeated dose toxicity
rat
sub-chronic
Regulatory source
p.15
SCCS Opinion

Safety Conclusion

sccs_opinions
The SCCNFP is of the opinion that the information submitted is inadequate to assess the safe use of the substance. Before any further consideration, the following information is required: complete physico-chemical characterisation of the test substances used, including data on stability; data on percutaneous absorption following the SCCNFP Notes of Guidance; data on the genotoxicity/mutagenicity following the relevant SCCNFP-opinions and in accordance with the Notes of Guidance.

Key concerns: Inadequate dossier: missing physico-chemical characterisation/stability data, percutaneous absorption data, and genotoxicity/mutagenicity data. COLIPA No A80 (hair dye ingredient).

Opinion date: 2004-12-07

Source Citation

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