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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
22 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):
40
Modified dose descriptor starting point:
NOAEC
Value:
882 mg/m³
Explanation for the modification of the dose descriptor starting point:
The NOAEC long-term, inhalation is based on a NOAEL long-term, oral. A sub-chronic repeated dose oral toxicity study is proposed. Based on available information the NOAEL long-term oral is assumed to be 1000 mg/kg bw/day. See IULCID section 7.5.2 for details on route to route extrapolation.
AF for dose response relationship:
1
Justification:
Default value with NOAEL as starting point.
AF for differences in duration of exposure:
2
Justification:
Extrapolation from sub-chronic to chronic study duration.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value.
AF for other interspecies differences:
1
Justification:
There is no indication of toxicokinetic or toxicodynamic differences between species.
AF for intraspecies differences:
5
Justification:
Default value for workers.
AF for the quality of the whole database:
1
Justification:
Good quality database.
AF for remaining uncertainties:
1
Justification:
No uncertainties remaining.
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:
25 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):
40
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The NOAEC long-term, dermal is based on a NOAEL long-term, oral. A sub-chronic repeated dose oral toxicity study is proposed. Based on available information the NOAEL long-term oral is assumed to be 1000 mg/kg bw/day. See IULCID section 7.5.3 for details on route to route extrapolation.
AF for dose response relationship:
1
Justification:
Default value with NOAEL as starting point.
AF for differences in duration of exposure:
2
Justification:
Extrapolation from sub-chronic to chronic study duration.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value.
AF for other interspecies differences:
1
Justification:
No indication of toxicokinetic or toxicodynamic differences between species.
AF for intraspecies differences:
5
Justification:
Default value for workers.
AF for the quality of the whole database:
1
Justification:
Good quality database.
AF for remaining uncertainties:
1
Justification:
No uncertainties remaining.
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:
5.5 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):
80
Modified dose descriptor starting point:
NOAEC
Value:
438 mg/m³
Explanation for the modification of the dose descriptor starting point:
The NOAEC long-term, inhalation is based on a NOAEL long-term, oral. A sub-chronic repeated dose oral toxicity study is proposed. Based on available information the NOAEL long-term oral is assumed to be 1000 mg/kg bw/day. See IULCID section 7.5.2 for details on route to route extrapolation.
AF for dose response relationship:
1
Justification:
Default value with NOAEL as starting point.
AF for differences in duration of exposure:
2
Justification:
Extrapolation from sub-chronic to chronic study duration
AF for interspecies differences (allometric scaling):
4
Justification:
Default value.
AF for other interspecies differences:
1
Justification:
No indication of toxicokinetic or toxicodynamic differences between species.
AF for intraspecies differences:
10
Justification:
Default value for the general public.
AF for the quality of the whole database:
1
Justification:
Good quality database.
AF for remaining uncertainties:
1
Justification:
No uncertainties remaining.
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:
12.5 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):
80
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The NOAEC long-term, dermal is based on a NOAEL long-term, oral. A sub-chronic repeated dose oral toxicity study is proposed. Based on available information the NOAEL long-term oral is assumed to be 1000 mg/kg bw/day. See IULCID section 7.5.3 for details on route to route extrapolation.
AF for dose response relationship:
1
Justification:
Default value with NOAEL as starting point.
AF for differences in duration of exposure:
2
Justification:
Extrapolation from sub-chronic to chronic study duration.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value.
AF for other interspecies differences:
1
Justification:
No indication of toxicokinetic or toxicodynamic differences between species.
AF for intraspecies differences:
10
Justification:
Default value for the general public.
AF for the quality of the whole database:
1
Justification:
Good quality database.
AF for remaining uncertainties:
1
Justification:
No uncertainties remaining.
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:
12.5 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):
80
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The NOAEC long-term, inhalation is based on a NOAEL long-term, oral. A sub-chronic repeated dose oral toxicity study is proposed. Based on available information the NOAEL long-term oral is assumed to be 1000 mg/kg bw/day.
AF for dose response relationship:
1
Justification:
Default value with NOAEL as starting point.
AF for differences in duration of exposure:
2
Justification:
Extrapolation from sub-chronic to chronic study duration.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value.
AF for other interspecies differences:
1
Justification:
No indication of toxicokinetic or toxicodynamic differences between species.
AF for intraspecies differences:
10
Justification:
Default value for the general public.
AF for the quality of the whole database:
1
Justification:
Good quality database.
AF for remaining uncertainties:
1
Justification:
No uncertainties remaining.
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