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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
73.1 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):
12.5
Dose descriptor starting point:
NOAEL
Value:
370 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
913 mg/m³
Explanation for the modification of the dose descriptor starting point:

The starting NOAEL is based on the chronic oral repeated dose study, therefore, there no additional correction for differences between human & experimental exposure conditions required.

AF for dose response relationship:
1
Justification:
Substance has low toxicity and dose-response curve is not steep
AF for differences in duration of exposure:
1
Justification:
No AF required as dose starting point is based on a chronic assessment
AF for interspecies differences (allometric scaling):
1
Justification:
Not required when converting animal oral exposure to human inhalation exposure
AF for other interspecies differences:
2.5
Justification:
No data available to justify alterations to standard factor
AF for intraspecies differences:
5
Justification:
No data available to justify alterations to standard factor for workers
AF for the quality of the whole database:
1
Justification:
There are sufficient studies available to indicate data from this study are representative
AF for remaining uncertainties:
1
Justification:
No data indicating there should be additional concerns
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:
10.4 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:
370 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
518 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting NOAEL is based on the chronic oral repeated dose study, therefore, there no additional correction for differences between human & experimental exposure conditions required.

AF for dose response relationship:
1
Justification:
Substance has low toxicity and dose-response curve is not steep
AF for differences in duration of exposure:
1
Justification:
No AF required as dose starting point is based on a chronic assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for allometric scaling for rat to human
AF for other interspecies differences:
2.5
Justification:
No data available to justify alterations to standard factor
AF for intraspecies differences:
5
Justification:
No data available to justify alterations to standard factor for workers
AF for the quality of the whole database:
1
Justification:
There are sufficient studies available to indicate data from this study are representative
AF for remaining uncertainties:
1
Justification:
No data indicating there should be additional concerns
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:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.9 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:
370 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
322 mg/m³
Explanation for the modification of the dose descriptor starting point:

The starting NOAEL is based on the chronic oral study, therefore, there no additional correction for differences between human & experimental exposure conditions required.

AF for dose response relationship:
1
Justification:
Substance has low toxicity and dose-response curve is not steep
AF for differences in duration of exposure:
1
Justification:
No AF required as dose starting point is based on a chronic assessment
AF for interspecies differences (allometric scaling):
1
Justification:
Not required when converting animal oral exposure to human inhalation exposure
AF for other interspecies differences:
2.5
Justification:
No data available to justify alterations to standard factor
AF for intraspecies differences:
10
Justification:
No data available to justify alterations to standard factor for general population
AF for the quality of the whole database:
1
Justification:
There are sufficient studies available to indicate data from this study are representative
AF for remaining uncertainties:
1
Justification:
No data indicating there should be additional concerns
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:
3.7 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:
370 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
370 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting NOAEL is based on the chronic oral study, therefore, there no additional correction for differences between human & experimental exposure conditions required.

AF for dose response relationship:
1
Justification:
Substance has low toxicity and dose-response curve is not steep
AF for differences in duration of exposure:
1
Justification:
No AF required as dose starting point is based on a chronic assessment)
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for allometric scaling for rat to human
AF for other interspecies differences:
2.5
Justification:
No data available to justify alterations to standard factor
AF for intraspecies differences:
10
Justification:
No data available to justify alterations to standard factor for general population
AF for the quality of the whole database:
1
Justification:
There are sufficient studies available to indicate data from this study are representative
AF for remaining uncertainties:
1
Justification:
No data indicating there should be additional concerns
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:
3.7 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:
370 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
370 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting NOAEL is based on the chronic oral study, therefore, there no additional correction for differences between human & experimental exposure conditions required.

AF for dose response relationship:
1
Justification:
Substance has low toxicity and dose-response curve is not steep
AF for differences in duration of exposure:
1
Justification:
No AF required as dose starting point is based on a chronic assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for allometric scaling for rat to human
AF for other interspecies differences:
2.5
Justification:
No data available to justify alterations to standard factor
AF for intraspecies differences:
10
Justification:
No data available to justify alterations to standard factor for general population
AF for the quality of the whole database:
1
Justification:
There are sufficient studies available to indicate data from this study are representative
AF for remaining uncertainties:
1
Justification:
No data indicating there should be additional concerns
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population