SCCS/1498/12 21 NOAEL rows Safety conclusion

1,4-Di-((2-sulpho-4, Acid Green 25

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1498/12.

Opinion Number

SCCS/1498/12

NOAEL Rows

21

Substances Covered

2

Substance(s) Covered

1,4-Di-((2-sulpho-4 Acid Green 25

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
1,4-Di-((2-sulpho-4 4403-90-1	NOAEL	100 mg/kg bw/day	rat	Regulatory source p.17 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	NOAEL	100 mg/kg bw/day	rat	Regulatory source p.17 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	NOAEL	100 mg/kg bw/day	rat	Regulatory source p.17 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	NOAEL	0.0004 mg/kg bw/d	dermal absorption rat oral 90-day	SCCS Opinion p.23 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	NOAEL	0.0004 mg/kg bw/d	dermal absorption rat oral 90-day	SCCS Opinion p.23 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	NOAEL	0.0004 mg/kg bw/d	dermal absorption rat oral 90-day	SCCS Opinion p.23 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	NOAEL	0.0004 mg/kg bw/d	dermal absorption rat oral 90-day	SCCS Opinion p.23 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	NOAEL	95 %	genotoxicity Chronic	SCCS Opinion p.18 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	NOAEL	95 %	genotoxicity Chronic	SCCS Opinion p.18 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	NOAEL	95 %	genotoxicity Chronic	SCCS Opinion p.18 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	NOAEL	95 %	genotoxicity Chronic	SCCS Opinion p.18 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	dermal absorption	0.0004 mg/kg bw/d	dermal absorption rat oral 90-day	Regulatory source p.23 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	dermal absorption	48 mg/kg bw/d	dermal absorption rat oral 90-day	Regulatory source p.23 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	dermal absorption	95 mg/kg bw/d	dermal absorption rat oral 90-day	Regulatory source p.23 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	developmental toxicity	100 mg/kg bw/day	developmental toxicity rat oral 13 week	Regulatory source p.23 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	developmental toxicity	300 mg/kg bw/day	developmental toxicity human developmental	Regulatory source p.22 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	developmental toxicity	300 mg/kg bw/day	developmental toxicity human developmental	Regulatory source p.22 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	developmental toxicity	300 mg/kg bw/day	developmental toxicity rat oral 13 week	Regulatory source p.23 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	developmental toxicity	1000 mg/kg bw/day	developmental toxicity human developmental	Regulatory source p.22 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	developmental toxicity	1000 mg/kg bw/day	developmental toxicity rat oral 13 week	Regulatory source p.23 SCCS Opinion
1,4-Di-((2-sulpho-4 4403-90-1	genotoxicity	95 %	genotoxicity Chronic	Regulatory source p.18 SCCS Opinion

Safety Conclusion

sccs_opinions Max N/A (cross-resistance assessment only)

Scientific opinion (not a safety conclusion) — addressed cross-resistance to medical azoles; no new safety limits set

Key concerns: Antifungal cross-resistance to azole medicinal products (itraconazole, fluconazole, etc.); concern for immunocompromised individuals

Opinion date: 26 February 2013

Source Citation

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