Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
440 µg/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):
25
Dose descriptor starting point:
NOAEL
Value:
12 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
11 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAECcorr=NOAELoral*(1/0.38 m3 /kg/d)*(ABSoral-rat/ABSinhhuman)*(6.7 m3 (8h)/10 m3 (8h)) = 12.5


mg/kg/d*(1/0.38 m3 /kg/d)*(0.5*1)*0.67=11 mg/m3

AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
2.5
AF for other interspecies differences:
5
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
125 µg/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):
100
Dose descriptor starting point:
NOAEL
Value:
12.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

An Allometric Scaling Factor of 4 plus an additional Assessment Factor of 2.5-fold was applies 4 as per E.C.H.A. Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of the dose [concentration]-response for human health, page 30 and Table R.8-3. An Intraspecies Worker Assessment of 5-fold is used as per E.C.H.A. Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of the dose [concentration]-response for human health.Appendix R.8-3, Table R.8-19, page 76 with a Duration correction of subacute to chronic exposure of 2-fold.

AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low 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:
220 µg/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):
50
Dose descriptor starting point:
NOAEL
Value:
12.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
11 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAECcorr=NOAELoral*(1/0.38 m3 /kg/d)*(ABSoral-rat/ABSinhhuman)*(6.7 m3 (8h)/10 m3 (8h)) = 12.5


mg/kg/d*(1/0.38 m3 /kg/d)*(0.5*1)*0.67=11 mg/m3

AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
2.5
AF for other interspecies differences:
10
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
62.5 µg/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):
200
Dose descriptor starting point:
NOAEL
Value:
12.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

An Allometric Scaling Factor of 4 plus an additional Assessment Factor of 2.5-fold was applies 4 as per E.C.H.A. Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of the dose [concentration]-response for human health, page 30 and Table R.8-3. An Intraspecies General Population Assessment of 10-fold is used as per E.C.H.A. Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of the dose [concentration]-response for human health.Appendix R.8-3, Table R.8-19, page 76 with a Duration correction of subacute to chronic exposure of 2-fold.

AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
62.5 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):
200
Dose descriptor starting point:
NOAEL
Value:
12.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

An Allometric Scaling Factor of 4 plus an additional Assessment Factor of 2.5-fold was applies 4 as per E.C.H.A. Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of the dose [concentration]-response for human health, page 30 and Table R.8-3. An Intraspecies General Population Assessment of 10-fold is used as per E.C.H.A. Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of the dose [concentration]-response for human health.Appendix R.8-3, Table R.8-19, page 76 with a Duration correction of subacute to chronic exposure of 2-fold.

AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population