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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.94 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:
70.53 mg/m³
Explanation for the modification of the dose descriptor starting point:
The dose descriptor giving the lowest DNEL is not chosen as the original reference is not available for the study (Supporting, RL4, Rat/HLS, 2011_Repeated dose toxicity: oral.003) and the reliability cannot be assessed. Inhalatory N(L)OAEC= oral N(L)OAEL*(1/0.38 m3/kg/d)*0.67*(ABSoral/ABSinh.) Differences in absorption Abs (oral-rat) / Abs (inhalation-human): 0.5
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
sub-acute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
allometric scaling not used for inhalation
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
for workers
AF for the quality of the whole database:
1
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)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.26 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:
80 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The dose descriptor giving the lowest DNEL is not chosen as the original reference is not available for the study (Supporting, RL4, Rat/HLS, 2011_Repeated dose toxicity: oral.003) and the reliability cannot be assessed. Dermal N(L)OAEC=oral (N(L)OAEL*( ABSoral/ABSdermal) Differences in absorption Abs (oral-rat) / Abs (dermal-human): 1
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
used for dermal
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
for workers
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown (no further information necessary)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.231 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:
34.78 mg/m³
Explanation for the modification of the dose descriptor starting point:
The dose descriptor giving the lowest DNEL is not chosen as the original reference is not available for the study (Supporting, RL4, Rat/HLS, 2011_Repeated dose toxicity: oral.003) and the reliability cannot be assessed. Inhalation N(L)OAEC= oral N(L)OAEL*(1/1.15 m3/kg/d)*(ABSoral/ABSinh.) Differences in absorption Abs (oral-rat) / Abs (inhalation-human): 0.5
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
sub-acute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
not used for inhalation
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
General Population
AF for the quality of the whole database:
1
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)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.133 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:
80 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Dermal N(L)OAEC=oral (N(L)OAEL*( ABSoral/ABSdermal) Differences in absorption Abs (oral-rat) / Abs (dermal-human): 1
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
used for dermal
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.133 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:
80 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The dose descriptor giving the lowest DNEL is not chosen as the original reference is not available for the study (Supporting, RL4, Rat/HLS, 2011_Repeated dose toxicity: oral.003) and the reliability cannot be assessed.
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
used for oral
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
General Population
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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