Registration Dossier
Registration Dossier
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EC number: 292-054-9 | CAS number: 90530-16-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.76 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 132.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- It is assumed that the oral absorption rate is 50% of that of the inhalation absorption. ABSoral/rat=oral absorption rate in rats, ABSinh./human=inhalation absorption rate in humans. NOAEC: Workers Inhalatory NOAECcorr=NOAELoral*(1/0.38 m3/kg/d)*(ABSoral-rat/ABSinhhuman)*(6.7 m3 (8h)/10 m3 (8h)) = 150mg/kg/d*(1/0.38 m3/kg/d)*(0.5*1)*0.67=132.2mg/m3
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- Justification:
- not used for inhalation
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- Justification:
- workers
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Workers corrected Dermal NOAEC= oral NOAEL*(ABS oral/ABS dermal) It is assumed that the oral absorption rate is 10% of that of the dermal absorption. ABS oral /ABS dermal = 10 Workers Corrected DERMAL NOAEC= 150 mg/kg bw/day * 10 = 1500 mg/kg bw/day See it OECD document: ENV /JM/MONO(2011)36 GUIDANCE NOTES ON DERMAL ABSORPTION Series on Testing Assessment No 156 18 -Aug-2011Workers Corrected Dermal NOAEC= 150 mg/kg bw/day *10 = 1500 mg/kg bw/ day
See it SeSee it OECD document: ENV/JM/MONO(2011)36 GUIDANCE NOTES ON DERMAL ABSORPTION Series on Testing and Assessment No. 156 18-Aug-2011
Workers Corrected Dermal NOAEC= 150 mg/kg bw/day * 10 = 1500 mg/kg bw/day
See it OECD document:
ENV/JM/MONO(2011)36 GUIDANCE NOTES ON DERMAL ABSORPTION Series on Testing and Assessment No. 156 18-Aug-2011
Workers Corrected Dermal NOAEC = oral NOAEL * (ABS oral/ ABS dermal)
It is assumed that the oral absorption rate is10% of thatof the dermal absorption. ABS oral/ ABS dermal =10
Workers Corrected Dermal NOAEC = oral NOAEL * (ABS oral/ ABS dermal)
It is assumed that the oral absorption rate is10% of thatof the dermal absorption. ABS oral/ ABS dermal =10
Workers Corrected Dermal NOAEC = oral NOAEL * (ABS oral/ ABS dermal)
It is assumed that the oral absorption rate is10% of thatof the dermal absorption. ABS oral/ ABS dermal =10
Workers Corrected Dermal NOAEC = oral NOAEL * (ABS oral/ ABS dermal)
It is assumed that the oral absorption rate is10% of thatof the dermal absorption. ABS oral/ ABS dermal =10
Workers Corrected Dermal NOAEC = 150 mg/kg bw/day*10=1500mg/kg bw /day
See it OECD document: ENV/JM/MONO(2011)36 GUIDANCE NOTES ON DERMAL ABSORPTION Series on Testing and Assessment No. 156 18-Aug-2011
IIIt is assumed that the oral absorption rate is10% of thatof the dermal absorption. ABS oral/ ABS dermal =10
10% dermal absorption was assumed
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- It is assumed that the oral absorption rate is 10% of that of the dermal absorption. ABS oral / dermal =10
- AF for intraspecies differences:
- 5
- Justification:
- worker
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.43 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 65.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- It is assumed that the oral absorption rate is 50% of that of the inhalation absorption. AB ABSoral/rat=oral absorption rate in rats, ABSinh./human=inhalation absorption rate in humans NOAEC: General population inhalatroy NOAECcorr=NOAELoral*(1/1.15 m3/kg/d)*(ABSoral-rat/ABSinh-human) = 150 mg/kg/d*(1/1.15 m3/kg/d)*(0.5*1)=65.2 mg/m3
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- general population
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
General population Corrected Dermal NOAEC = oral NOAEL * (ABS oral/ ABS dermal) It is assumed that the oral absorption rate is 100% of that of the dermal absorption. ABS oral/ ABS dermal = 1 General population Corrected Dermal NOAEC = 150 mg/kg bw/day *10= 1500mg/kg bw /day
Workers corrected Dermal NOAEC= oral NOAEL*(ABS oral/ABS dermal) It is assumed that the oral absorption rate is 10% of that of the dermal absorption. ABS oral /ABS dermal = 10 Workers Corrected DERMAL NOAEC= 150 mg/kg bw/day * 10 = 1500 mg/kg bw/day See it OECD document: ENV /JM/MONO(2011)36 GUIDANCE NOTES ON DERMAL ABSORPTION Series on Testing Assessment No 156 18 -Aug-2011
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- oral to oral no need extrapolation
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
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