SCCS/1000/06 11 NOAEL rows Safety conclusion

1-Hexyl-1H-pyrazole-4,5-diamine, HC Blue N°2 (B37)

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1000/06.

Opinion Number
SCCS/1000/06
NOAEL Rows
11
Substances Covered
2

Substance(s) Covered

1-Hexyl-1H-pyrazole-4,5-diamine HC Blue N°2 (B37)

NOAEL Values Extracted from This Opinion

Substance Endpoint Value Study Source
1-Hexyl-1H-pyrazole-4,5-diamine
1361000-06-7
 NOAEL 8 mg/kg bw/day rat
oral
90 days
Regulatory source
p.23
SCCS Opinion
1-Hexyl-1H-pyrazole-4,5-diamine
1361000-06-7
 dermal absorption 0.037 mg/kg bw/d dermal absorption
rat
oral
90-day
Regulatory source
p.43
SCCS Opinion
1-Hexyl-1H-pyrazole-4,5-diamine
1361000-06-7
 dermal absorption 4.1 mg/kg bw/d dermal absorption
rat
oral
90-day
Regulatory source
p.43
SCCS Opinion
1-Hexyl-1H-pyrazole-4,5-diamine
1361000-06-7
 dermal absorption 5 mg/kg bw/d dermal absorption
rat
oral
90-day
Regulatory source
p.43
SCCS Opinion
1-Hexyl-1H-pyrazole-4,5-diamine
1361000-06-7
 developmental toxicity 8 mg/kg bw/day developmental toxicity
developmental
Regulatory source
p.29
SCCS Opinion
1-Hexyl-1H-pyrazole-4,5-diamine
1361000-06-7
 developmental toxicity 8 mg/kg bw/day developmental toxicity
rat
oral
90 days
Regulatory source
p.43
SCCS Opinion
1-Hexyl-1H-pyrazole-4,5-diamine
1361000-06-7
 genotoxicity 5 mg/kg bw/day genotoxicity
rat
oral
90 days
Regulatory source
p.23
SCCS Opinion
1-Hexyl-1H-pyrazole-4,5-diamine
1361000-06-7
 genotoxicity 5 mg/kg bw/day genotoxicity
Chronic
Regulatory source
p.23
SCCS Opinion
1-Hexyl-1H-pyrazole-4,5-diamine
1361000-06-7
 genotoxicity 5 mg/kg bw/day genotoxicity
Chronic
Regulatory source
p.23
SCCS Opinion
1-Hexyl-1H-pyrazole-4,5-diamine
1361000-06-7
 genotoxicity 8 mg/kg bw/day genotoxicity
rat
oral
90 days
Regulatory source
p.23
SCCS Opinion
1-Hexyl-1H-pyrazole-4,5-diamine
1361000-06-7
 repeated dose toxicity 5 mg/kg bw/day repeated dose toxicity
rat
oral
sub-chronic
Regulatory source
p.43
SCCS Opinion

Safety Conclusion

sccs_opinions Max 2.8%
safe

Key concerns: secondary amine; nitrosamine <50ppb; sensitisation not excluded

Opinion date: 19 December 2006

Source Citation

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