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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2.73 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECHA R.8 guidance incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
45
Dose descriptor starting point:
LOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
123 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point LOAEL (dermal rat 13 week repeat dose studies); x [1/0.43 {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}] x [6.7/10 {light work ventilation rate}] x [1/0.38{adjust for human inhalation rate from dermal}] = 123 mg/m3

AF for dose response relationship:
3
Justification:
LOAEL converted to a NOAEL (ECHA R.8 guidance)
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA R.8 value)
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not required
AF for other interspecies differences:
2.5
Justification:
Interspecies rat to human (ECHA R.8 value)
AF for intraspecies differences:
3
Justification:
ECETOC intraspecies AF
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
1
Justification:
Not required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.58 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: ECHA R.8 guidance incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
45
Dose descriptor:
NOAEC
Value:
251 mg/m³
AF for dose response relationship:
1
Justification:
Not required, starting point was a NOAEC
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic (ECHA R.8 guidance)
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not required
AF for other interspecies differences:
2.5
Justification:
Interspecies rat to human (ECHA R.8 guidance)
AF for intraspecies differences:
3
Justification:
ECETOC intraspecies AF
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
1
Justification:
Not requried
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:
0.97 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECHA R.8 guidance incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
72
Dose descriptor starting point:
LOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
69.8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point LOAEL (dermal rat 13 week repeat dose study); x [1/0.43 {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}] = 69 mg/kg/day

AF for dose response relationship:
3
Justification:
LOAEL converted to NOAEL (ECHA R.8 value)
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA R.8 value)
AF for interspecies differences (allometric scaling):
4
Justification:
Interspecies rat to human (ECHA R8 value)
AF for other interspecies differences:
1
Justification:
Not required
AF for intraspecies differences:
3
Justification:
ECETOC intrapsecies AF
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
1
Justification:
Not required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high 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:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.74 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA R.8 guidance incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
120
Dose descriptor starting point:
LOAEL
Value:
125 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
89.3 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point LOAEL (oral rat 13 week repeat dose study); x 5 days per week adjusted [5/7 {5 days/7 days}] = 89.3 mg/kg/day

AF for dose response relationship:
3
Justification:
LOAEL converted to a NOAEL (ECHA R.8 guidance)
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA R.8 value)
AF for interspecies differences (allometric scaling):
4
Justification:
Interspecies rat to man (ECHA R.8 value)
AF for other interspecies differences:
1
Justification:
Not required
AF for intraspecies differences:
5
Justification:
ECETOC intraspecies AF
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
1
Justification:
Not required
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:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population