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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
8.82 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):
30
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEC
Value:
264.47 mg/m³
Explanation for the modification of the dose descriptor starting point:

According to ECHA's Guidance R8 (Characterisation of dose [concentration]-response for human health), Appendix R-8 -2, example B.3, the corrected NOAEC (inhalation) can be calculated as follow:

Corrected NOAEC (inhalation) = NOAEL(oral) * (1/0.38)*(absorption oral rat/absorption inhalation human)*(6.7/10) = 264.47 mg/m3, taking into account worst case factors (absorption oral rat of 50% and absorption inhalation human of 100%) and a NOAEL(oral) of 300 mg/kg bw/d.

AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
57.173 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
15
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
LOAEC
Value:
857.6 mg/m³
Explanation for the modification of the dose descriptor starting point:

The acute inhalation toxicity study concluded to LC50 >= 1.28 mg/L. The study indicated some clinical signs in the rats at this concentration. Therefore, it can be assumed that the LOAEC is 1.28 mg/L (1280 mg/m3).

According to ECHA's Guidance R8 (Characterisation of dose [concentration]-response for human health, Appendix R-8 -2, example A.2, the corrected LOAEC (inhalation) can be calculated as follow:

Corrected LOAEC (inhalation) = LOAEC(inhalation) *(6.7/10) = 857.6 mg/m3, considering the worst case situation where inhalation absorption in the rat is the same as inhalation absorption in human.

AF for dose response relationship:
3
AF for intraspecies differences:
5
AF for the quality of the whole database:
1

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)
Most sensitive endpoint:
acute toxicity
DNEL related information

Workers - 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):
120
Dose descriptor starting point:
NOAEL
Explanation for the modification of the dose descriptor starting point:

According to ECHA's Guidance R8 (Characterisation of dose [concentration]-response for human health), Appendix R-8 -2, example B.5, the corrected NOAEL (dermal) can be calculated as follow:

Corrected NOAEL (dermal) = NOAEL(oral) * (absorption oral rat/absorption dermal human) = 300 mg/kg bw/d, taking into account worst case factors (absorption oral rat = absorption dermal human) and a NOAEL(oral) of 300 mg/kg bw/d.

AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.107 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
60
Dose descriptor starting point:
LOAEC
Modified dose descriptor starting point:
LOAEL
Value:
8.107 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The acute inhalation toxicity study concluded to LC50 >= 1.28 mg/L. The study indicated some clinical signs in the rats at this concentration. Therefore, it can be assumed that the LOAEC is 1.28 mg/L (1280 mg/m3).

According to ECHA's Guidance R8 (Characterisation of dose [concentration]-response for human health), Appendix R-8 -2, example B.4, the corrected LOAEC (inhalation) can be calculated as follow:

Corrected LOAEL (dermal) = LOAEC(inhalation) *sRVrat*(Abs inh rat/Abs dermal human) = 1280*0.38*1 = 486.4 mg/kg/d, considering the worst case situation where inhalation absorption in the rat is the same as dermal absorption in human.

AF for dose response relationship:
3
AF for interspecies differences (allometric scaling):
4
AF for intraspecies differences:
5
AF for the quality of the whole database:
1

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population