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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
37 µg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor starting point:
NOAEC
Value:
5.5 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
2.76 mg/m³
Explanation for the modification of the dose descriptor starting point:

The calculation of the DNEL is based on an inhalation NOAEC observed in a sub-acute inhalation study (OECD 412, 1989). The NOAEC is corrected to account for differences between experimental and human exposure conditions. It is further corrected for the difference between respiratory rates under standard conditions and under conditions of light activity (sRVhuman versus wRV)

NOAECcorr = NOAEC*(6hr per day/8hr per day)*(6.7m³ (8h)/10m³ (8h))

NOAECcorr = 2.76 mg/m³

AF for dose response relationship:
1
Justification:
The dose descriptor stating point is based on a NOAEC.
AF for differences in duration of exposure:
6
Justification:
DNEL is based on an inhalation sub-acute study.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not used for inhalation route.
AF for other interspecies differences:
2.5
Justification:
Default value according to ECHA REACH Guidance.
AF for intraspecies differences:
5
Justification:
Default value for workers according to ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
The DNEL is based on a high-quallity study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
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:
1.6 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:
5.7 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
79.8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The calculation of the DNEL is based on an oral NOAEL observed in a chronic oral study (OECD 453, 1991). The NOAEL is corrected to account for differences in absorption via the oral and dermal routes. An assessment of dermal absorption indicates limited penetration through the skin. A conservative estimate of 10% is therefore used for dermal absorption. Based on the available toxicokinetic data, the test substance is rapidly and almost completely absorbed, therefore a value of 100% oral absorption is assumed. The NOAEL is further corrected to account for differences in exposure frequency in the experimental study (7 days/week) vs. standard worker exposure (5 days/week).

Corrected dermal NOAEL = oral NOAEL*(abs-oral rat/abs-derm human)*(experimental exposure frequency/worker exposure frequency)

Corrected dermal NOAEL = 5.7*(100/10)*(7/5) = 79.8 mg/kg bw/day

AF for dose response relationship:
1
Justification:
The dose descriptor stating point is based on a NOAEL.
AF for differences in duration of exposure:
1
Justification:
DNEL is based on a chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
The experimental animal was rat.
AF for other interspecies differences:
2.5
Justification:
Default value according to ECHA REACH Guidance.
AF for intraspecies differences:
5
Justification:
Default value for workers according to ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
The DNEL is based on a high-quality study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity

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:
6.53 µg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor starting point:
NOAEC
Value:
5.5 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
0.98 mg/m³
Explanation for the modification of the dose descriptor starting point:

The calculation of the DNEL is based on an inhalation NOAEC observed in a sub-acute inhalation study (OECD 412, 1989). The NOAEC is corrected to account for differences between experimental conditions (6hr/day) and general population exposure conditions (24hr/day), as well as differences in experimental exposure frequency (5 days/week) and general population exposure frequency (7 days/week).

NOAECcorr = NOAEC*(6/24)*(5/7)

NOAECcorr = 0.98 mg/m³

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a NOAEL
AF for differences in duration of exposure:
6
Justification:
DNEL is based on a sub-acute inhalation study.
AF for interspecies differences (allometric scaling):
1
Justification:
AF for allometric scaling already included in ECHA starting point derivation method; no further factor required.
AF for other interspecies differences:
2.5
Justification:
Default value according to ECHA REACH Guidance.
AF for intraspecies differences:
10
Justification:
Default value for general population according to ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
The DNEL is based on a high-quality study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.57 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:
5.7 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
57 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The calculation of the DNEL is based on an oral NOAEL observed in a chronic oral study (OECD 453, 1991). The NOAEL is corrected to account for differences in absorption via the oral and dermal routes. An assessment of dermal absorption indicates limited penetration through the skin. A conservative estimate of 10% is therefore used for dermal absorption. Based on the available toxicokinetic data, the test substance is rapidly and almost completely absorbed, therefore a value of 100% oral absorption is assumed.

Correct dermal NOAEL = oral NOAEL x (abs-oral rat/abs-derm human)

Correct dermal NOAEL = 5.7 x (100/10) = 57 mg/kg bw/day

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a NOAEL.
AF for differences in duration of exposure:
1
Justification:
DNEL is based on a chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
The experimental animal was rat.
AF for other interspecies differences:
2.5
Justification:
Default value according to ECHA REACH Guidance.
AF for intraspecies differences:
10
Justification:
Default value for general population according to ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
The DNEL is based on a high-quality study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity

General Population - Hazard via oral route

Systemic effects

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

No modification of the dose descriptor starting point is necessary.

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a NOAEL.
AF for differences in duration of exposure:
1
Justification:
DNEL is based on a chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
The experimental animal was rat.
AF for other interspecies differences:
2.5
Justification:
Default value according to ECHA REACH Guidance.
AF for intraspecies differences:
10
Justification:
Default value for general population according to ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
The DNEL is based on a high-quality study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population