SCCS/1164/08 19 NOAEL rows Safety conclusion

HC Orange No. 1, HC Orange n° 1

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1164/08.

Opinion Number
SCCS/1164/08
NOAEL Rows
19
Substances Covered
2

Substance(s) Covered

HC Orange No. 1 HC Orange n° 1

NOAEL Values Extracted from This Opinion

Substance Endpoint Value Study Source
HC Orange No. 1
54381-08-7
 NOAEL 0.024 mg/kg bw dermal absorption
rat
oral
90-day
SCCS Opinion
p.28
SCCS Opinion
HC Orange No. 1
54381-08-7
 NOAEL 0.024 mg/kg bw dermal absorption
rat
oral
90-day
SCCS Opinion
p.28
SCCS Opinion
HC Orange No. 1
54381-08-7
 NOAEL 0.024 mg/kg bw dermal absorption
rat
oral
90-day
SCCS Opinion
p.28
SCCS Opinion
HC Orange No. 1
54381-08-7
 NOAEL 0.024 mg/kg bw dermal absorption
rat
oral
90-day
SCCS Opinion
p.28
SCCS Opinion
HC Orange No. 1
54381-08-7
 NOAEL 25 mg/kg bw dermal absorption
rat
oral
90-day
SCCS Opinion
p.28
SCCS Opinion
HC Orange No. 1
54381-08-7
 NOAEL 25 mg/kg bw dermal absorption
rat
oral
90-day
SCCS Opinion
p.28
SCCS Opinion
HC Orange No. 1
54381-08-7
 NOAEL 25 mg/kg bw dermal absorption
rat
oral
90-day
SCCS Opinion
p.28
SCCS Opinion
HC Orange No. 1
54381-08-7
 NOAEL 25 mg/kg bw dermal absorption
rat
oral
90-day
SCCS Opinion
p.28
SCCS Opinion
HC Orange No. 1
54381-08-7
 carcinogenicity 25 mg/kg bw/d carcinogenicity
Chronic
Regulatory source
p.16
SCCS Opinion
HC Orange No. 1
54381-08-7
 dermal absorption 0.024 mg/kg bw dermal absorption
rat
oral
90-day
Regulatory source
p.28
SCCS Opinion
HC Orange No. 1
54381-08-7
 dermal absorption 25 mg/kg bw dermal absorption
rat
oral
90-day
Regulatory source
p.28
SCCS Opinion
HC Orange No. 1
54381-08-7
 dermal absorption 25 mg/kg bw dermal absorption
rat
oral
90-day
Regulatory source
p.28
SCCS Opinion
HC Orange No. 1
54381-08-7
 developmental toxicity 0.15 % developmental toxicity
rat
dermal
13 week
Regulatory source
p.27
SCCS Opinion
HC Orange No. 1
54381-08-7
 developmental toxicity 75 mg/kg/day developmental toxicity
oral
developmental
Regulatory source
p.26
SCCS Opinion
HC Orange No. 1
54381-08-7
 developmental toxicity 250 mg/kg/day developmental toxicity
oral
developmental
Regulatory source
p.26
SCCS Opinion
HC Orange No. 1
54381-08-7
 repeated dose toxicity 300 mg/kg/day repeated dose toxicity
rat
oral
Sub-chronic
Regulatory source
p.15
SCCS Opinion
HC Orange No. 1
54381-08-7
 repeated dose toxicity 750 mg/kg/day repeated dose toxicity
rat
oral
Sub-chronic
Regulatory source
p.15
SCCS Opinion
HC Orange No. 1
54381-08-7
 reproductive toxicity 25 mg/kg bw/d reproductive toxicity
guinea pig
developmental
Regulatory source
p.28
SCCS Opinion
HC Orange No. 1
54381-08-7
 reproductive toxicity 75 mg/kg bw/day reproductive toxicity
guinea pig
developmental
Regulatory source
p.28
SCCS Opinion

Safety Conclusion

sccs_opinions Max 1.0%
safe

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

Opinion date: 30 September 2008

Source Citation

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