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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.6 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
NOAEL
Value:
18 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
20 mg/m³
Explanation for the modification of the dose descriptor starting point:

The starting point from an oral study (oral NOAEL) is modified taking into account activity levels (*6.7/10), breathing rate (*1/0.38), the extent of oral absorption (46%, measured) and the extent of inhalation absorption (100%, assumed), and differerences in exposure pattern (*7/5).  The modified starting point (inhalation NOAEC) is therefore 20 mg/m3.

AF for dose response relationship:
1
Justification:
An AF of 1 is used as the starting point is a NOAEL.
AF for differences in duration of exposure:
1
Justification:
An AF of 1 is used as the starting point is from a chronic study.
AF for interspecies differences (allometric scaling):
1
Justification:
An AF is not required as allometric factors have already been taken into account when deriving the modified starting point.
AF for other interspecies differences:
2.5
Justification:
A default AF of 2.5 is used, in line with ECHA guidance.
AF for intraspecies differences:
5
Justification:
A default AF of 5 is used, in line with ECHA guidance.
AF for the quality of the whole database:
1
Justification:
An AF of 1 is used as the database is of high quality.
AF for remaining uncertainties:
1
Justification:
An AF of 1 is used in the absence of remaining uncertainties.
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:
116 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):
50
Dose descriptor starting point:
NOAEL
Value:
18 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
5 796 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting point from an oral study (oral NOAEL) is modified taking into account the extent of oral absorption (46%, measured) and the extent of dermal absorption (0.2%, measured), and differerences in exposure pattern (*7/5).  The modified starting point (dermal NOAEL) is therefore 5796 mg/kg bw/d.

AF for dose response relationship:
1
Justification:
An AF of 1 is used as the starting point is a NOAEL.
AF for differences in duration of exposure:
1
Justification:
An AF of 1 is used as the starting point is from a chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
An AF of 4 is used as the starting point is from a rat study.
AF for other interspecies differences:
2.5
Justification:
A default AF of 2.5 is used, in line with ECHA guidance.
AF for intraspecies differences:
5
Justification:
A default AF of 5 is used, in line with ECHA guidance.
AF for the quality of the whole database:
1
Justification:
An AF of 1 is used as the database is of high quality.
AF for remaining uncertainties:
1
Justification:
An AF of 1 is used in the absence of remaining uncertainties.
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

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:
0.3 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:
NOAEL
Value:
18 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
7.2 mg/m³
Explanation for the modification of the dose descriptor starting point:

The starting point from an oral study (oral NOAEL) is modified taking into breathing rate (*1/1.15), the extent of oral absorption (46%, measured) and the extent of inhalation absorption (100%, assumed). The modified starting point (inhalation NOAEC) is therefore 7.2 mg/m3.

AF for dose response relationship:
1
Justification:
An AF of 1 is used as the starting point is a NOAEL.
AF for differences in duration of exposure:
1
Justification:
An AF of 1 is used as the starting point is from a chronic study.
AF for interspecies differences (allometric scaling):
1
Justification:
An AF is not required as allometric factors have already been taken into account when deriving the modified starting point.
AF for other interspecies differences:
2.5
Justification:
A default AF of 2.5 is used, in line with ECHA guidance.
AF for intraspecies differences:
10
Justification:
A default AF of 10 is used, in line with ECHA guidance.
AF for the quality of the whole database:
1
Justification:
An AF of 1 is used as the database is of high quality.
AF for remaining uncertainties:
1
Justification:
An AF of 1 is used in the absence of remaining uncertainties.
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:
41 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):
100
Dose descriptor starting point:
NOAEL
Value:
18 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
4 140 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting point from an oral study (oral NOAEL) is modified taking into account the extent of oral absorption (46%, measured) and the extent of dermal absorption (0.2%, measured). The modified starting point (dermal NOAEL) is therefore 4140 mg/kg bw/d.

AF for dose response relationship:
1
Justification:
An AF of 1 is used as the starting point is a NOAEL.
AF for differences in duration of exposure:
1
Justification:
An AF of 1 is used as the starting point is from a chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
An AF of 4 is used as the starting point is from a rat study.
AF for other interspecies differences:
2.5
Justification:
A default AF of 2.5 is used, in line with ECHA guidance.
AF for intraspecies differences:
10
Justification:
A default AF of 10 is used, in line with ECHA guidance.
AF for the quality of the whole database:
1
Justification:
An AF of 1 is used as the database is of high quality.
AF for remaining uncertainties:
1
Justification:
An AF of 1 is used in the absence of remaining uncertainties.
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.18 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):
100
Dose descriptor starting point:
NOAEL
Value:
18 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
18 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The dose descriptor starting point is from an oral study and does not therefore require modification.

AF for dose response relationship:
1
Justification:
An AF of 1 is used as the starting point is a NOAEL.
AF for differences in duration of exposure:
1
Justification:
An AF of 1 is used as the starting point is from a chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
An AF of 4 is used as the starting point is from a rat study.
AF for other interspecies differences:
2.5
Justification:
A default AF of 2.5 is used, in line with ECHA guidance.
AF for intraspecies differences:
10
Justification:
A default AF of 10 is used, in line with ECHA guidance.
AF for the quality of the whole database:
1
Justification:
An AF of 1 is used as the database is of high quality.
AF for remaining uncertainties:
1
Justification:
An AF of 1 is used in the absence of remaining uncertainties.
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