Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
15.4 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):
25
Dose descriptor starting point:
NOAEC
Value:
765 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
384 mg/m³
Explanation for the modification of the dose descriptor starting point:

Modification for exposure: 6/8 (Rat Exposure condition (6h) / Worker Exposure condition (8 h) 


Modification for respiratory volume: 6.7/10 (respiratory rate difference under standard conditions and under conditions of light activity for 8 hours)

AF for dose response relationship:
1
Justification:
Default (DNEL generation plugin)
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Default
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:
0.418 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
Dose descriptor starting point:
NOAEL
Value:
89.5 mg/kg bw/day
Value:
125.3 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL generation plugin)

AF for dose response relationship:
1
Justification:
Default (DNEL generation plugin)
AF for differences in duration of exposure:
6
Justification:
Default (DNEL generation plugin)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL generation plugin)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL generation plugin)
AF for intraspecies differences:
5
Justification:
Default (DNEL generation plugin)
AF for the quality of the whole database:
1
Justification:
Default (DNEL generation plugin)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

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:
DNEL (Derived No Effect Level)
Value:
2.74 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):
50
Dose descriptor starting point:
NOAEC
Value:
765 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
137 mg/m³
Explanation for the modification of the dose descriptor starting point:

Modification for exposure: (6/24)*(5/7) (Rat Exposure condition (6h – 5/7 days) / General population Exposure condition (24 h – 7/7 days)

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Default
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:
0.149 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
Dose descriptor starting point:
NOAEL
Value:
89.5 mg/kg bw/day
Value:
89.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL generation plugin)

AF for dose response relationship:
1
Justification:
Default (DNEL generation plugin)
AF for differences in duration of exposure:
6
Justification:
Default (DNEL generation plugin)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL generation plugin)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL generation plugin)
AF for intraspecies differences:
10
Justification:
Default (DNEL generation plugin)
AF for the quality of the whole database:
1
Justification:
Default (DNEL generation plugin)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.149 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
Dose descriptor starting point:
NOAEL
Value:
89.5 mg/kg bw/day
Value:
89.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL generation plugin)

AF for dose response relationship:
1
Justification:
Default (DNEL generation plugin)
AF for differences in duration of exposure:
6
Justification:
Default (DNEL generation plugin)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL generation plugin)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL generation plugin)
AF for intraspecies differences:
10
Justification:
Default (DNEL generation plugin)
AF for the quality of the whole database:
1
Justification:
Default (DNEL generation plugin)
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