SCCS/1479/12 32 NOAEL rows Safety conclusion

s................................................................... 98, Toluene-2,5-diamine and its sulfate

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1479/12.

Opinion Number
SCCS/1479/12
NOAEL Rows
32
Substances Covered
2

Substance(s) Covered

s................................................................... 98 Toluene-2,5-diamine and its sulfate

NOAEL Values Extracted from This Opinion

Substance Endpoint Value Study Source
95-70-5
95-70-5
 NOAEL 2.5 mg/kg bw/d rat
oral
12-week
Regulatory source
p.32
SCCS Opinion
95-70-5
95-70-5
 NOAEL 2.5 mg/kg bw/d rat
oral
28-day
Regulatory source
p.33
SCCS Opinion
95-70-5
95-70-5
 NOAEL 2.5 mg/kg bw rat
oral
Regulatory source
p.60
SCCS Opinion
95-70-5
95-70-5
 NOAEL 10 mg/kg bw/d 3-day
Regulatory source
p.32
SCCS Opinion
95-70-5
95-70-5
 NOAEL 10 mg/kg bw rat
oral
91-day
Regulatory source
p.61
SCCS Opinion
95-70-5
95-70-5
 NOAEL 10 mg/kg bw rat
oral
91-day
Regulatory source
p.61
SCCS Opinion
95-70-5
95-70-5
 NOAEL 10 mg/kg bw/day rat
oral
91 day
Regulatory source
p.62
SCCS Opinion
95-70-5
95-70-5
 NOAEL 10 mg/kg bw rat
oral
91-day
Regulatory source
p.65
SCCS Opinion
95-70-5
95-70-5
 NOAEL 10 mg/kg bw rat
oral
91-day
Regulatory source
p.65
SCCS Opinion
95-70-5
95-70-5
 NOAEL 10 mg/kg bw/day rat
oral
91 day
Regulatory source
p.66
SCCS Opinion
95-70-5
95-70-5
 NOAEL 10 mg/kg bw/day rat
Regulatory source
p.62
SCCS Opinion
95-70-5
95-70-5
 NOAEL 50 mg/kg bw/d rat
oral
Regulatory source
p.48
SCCS Opinion
95-70-5
95-70-5
 NOAEL 50 mg/kg bw/d rat
Regulatory source
p.49
SCCS Opinion
95-70-5
95-70-5
 NOAEL 50 mg/kg bw/d rat
Regulatory source
p.49
SCCS Opinion
95-70-5
95-70-5
 NOAEL 50 mg/kg bw/d rat
Regulatory source
p.64
SCCS Opinion
95-70-5
95-70-5
 carcinogenicity 69 % carcinogenicity
rat
oral
90-day
Regulatory source
p.66
SCCS Opinion
95-70-5
95-70-5
 dermal absorption 0.39 mg/kg bw dermal absorption
rat
oral
90-day
Regulatory source
p.62
SCCS Opinion
95-70-5
95-70-5
 dermal absorption 6.9 mg/kg bw/d dermal absorption
rat
oral
90-day
Regulatory source
p.62
SCCS Opinion
95-70-5
95-70-5
 dermal absorption 10 mg/kg bw/d dermal absorption
rat
oral
90-day
Regulatory source
p.62
SCCS Opinion
95-70-5
95-70-5
 dermal absorption 69 % dermal absorption
rat
oral
90-day
Regulatory source
p.62
SCCS Opinion
95-70-5
95-70-5
 genotoxicity 10 mg/kg bw/d genotoxicity
oral
28-day
Regulatory source
p.34
SCCS Opinion
95-70-5
95-70-5
 repeated dose toxicity 60 mg/kg bw/d repeated dose toxicity
rat
oral
Sub-chronic
Regulatory source
p.31
SCCS Opinion
95-70-5
95-70-5
 reproductive toxicity 10 mg/kg bw/d reproductive toxicity
rabbit
oral
90-day
Regulatory source
p.63
SCCS Opinion
95-70-5
95-70-5
 reproductive toxicity 20 mg/kg bw/d reproductive toxicity
rabbit
oral
90-day
Regulatory source
p.63
SCCS Opinion
95-70-5
95-70-5
 reproductive toxicity 45 mg/kg bw/d reproductive toxicity
rabbit
oral
Regulatory source
p.47
SCCS Opinion
95-70-5
95-70-5
 reproductive toxicity 45 mg/kg bw/d reproductive toxicity
rabbit
oral
90-day
Regulatory source
p.63
SCCS Opinion
95-70-5
95-70-5
 reproductive toxicity 50 mg/kg bw/d reproductive toxicity
rabbit
oral
90-day
Regulatory source
p.63
SCCS Opinion
s................................................................... 98 NOAEL 1443 rat
Regulatory source
p.94
SCCS Opinion
s................................................................... 98 NOAEL 1443 rat
Regulatory source
p.94
SCCS Opinion
s................................................................... 98 NOAEL 1443 NOAEL study
rat
SCCS Opinion
p.94
SCCS Opinion
s................................................................... 98 NOAEL 1443 NOAEL study
rat
SCCS Opinion
p.94
SCCS Opinion
s................................................................... 98 NOAEL 1443 NOAEL study
rat
SCCS Opinion
p.94
SCCS Opinion

Safety Conclusion

sccs_opinions Max 0.6%
safe with restrictions

Key concerns: sensitisation potential; do not use with nitrosating agents; nitrosamine <50ppb

Opinion date: 18 September 2012

Source Citation

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