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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
11.75 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):
75
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
881 mg/m³
Explanation for the modification of the dose descriptor starting point:

1000 x 1/0.38 m3/kg/day x 0.5 (oral absorption rat 50%, inhalation absorption human 100%) x 6.7/10 m3

AF for dose response relationship:
1
Justification:
Clear NOAELs obtained in oral repeated dose studies
AF for differences in duration of exposure:
6
Justification:
default - subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling required for inhalation
AF for other interspecies differences:
2.5
Justification:
default - any remaining difference
AF for intraspecies differences:
5
Justification:
default for workers
AF for the quality of the whole database:
1
Justification:
data base complete for the tonnage band
AF for remaining uncertainties:
1
Justification:
no 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:
6.7 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):
300
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

1000 x 2 (50% oral absorption rat/25% dermal absorption human)

AF for dose response relationship:
1
Justification:
Clear NOAELs obtained in oral repeated dose studies
AF for differences in duration of exposure:
6
Justification:
deafult - subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default value for rats
AF for other interspecies differences:
2.5
Justification:
default - any remaining difference
AF for intraspecies differences:
5
Justification:
default for workers
AF for the quality of the whole database:
1
Justification:
data base complete for the tonnage band
AF for remaining uncertainties:
1
Justification:
no 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

The substance was tested via the oral route up to the limit dose of 1000 mg/kg/day in repeated dose studies and did not cause any adverse effects, either for general toxicity or reproductive toxicity. In fully compliant 28 -day toxicity and OECD 421 studies the NOAEL was 1000 mg/kg/day, the highest dose level tested. In addition, the substance is not acutely toxic, is neither a skin or a eye irritant, and has no skin sensitising potential. No genotoxic potential was evidenced in available studies. The NOAEL of 1000 mg/kg/day has been used as the starting point for deriving systemic long-term DNELs and is considered sufficiently protective for workers.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.9 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):
150
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
434.8 mg/m³
Explanation for the modification of the dose descriptor starting point:

1000 x 1/1.15 m3/kg/day x 0.5 (50% oral absorption rat/100% inhalation absorption human)

AF for dose response relationship:
1
Justification:
Clear NOAELs obtained in oral repeated dose studies
AF for differences in duration of exposure:
6
Justification:
default value - subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
no allometric scalig required for inhalation
AF for other interspecies differences:
2.5
Justification:
default - any remaining difference
AF for intraspecies differences:
10
Justification:
default for general population
AF for the quality of the whole database:
1
Justification:
database complete for the tonnage band
AF for remaining uncertainties:
1
Justification:
no 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:
3.33 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:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

1000 x 2 (50% oral absorption rat/25% dermal absorption human)

AF for dose response relationship:
1
Justification:
Clear NOAELs obtained in oral repeated dose studies.
AF for differences in duration of exposure:
6
Justification:
default - subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default for rats
AF for other interspecies differences:
2.5
Justification:
default for any remaining difference
AF for intraspecies differences:
10
Justification:
default for the general population
AF for the quality of the whole database:
1
Justification:
database complete for the tonnage band
AF for remaining uncertainties:
1
Justification:
no 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:
1.7 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):
600
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

the same extent of oral absorption in rats and humans (i.e. 50%) has been considered.

AF for dose response relationship:
1
Justification:
Clear NOAELs obtained in repeated-dose oral studies
AF for differences in duration of exposure:
6
Justification:
default - subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default for rats
AF for other interspecies differences:
2.5
Justification:
default for any remaining differences
AF for intraspecies differences:
10
Justification:
default for the general population
AF for the quality of the whole database:
1
Justification:
database complete for the tommange band
AF for remaining uncertainties:
1
Justification:
no 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

The substance was tested via the oral route up to the limit dose of 1000 mg/kg/day in repeated dose studies and did not cause any adverse effects, either for general toxicity or reproductive toxicity. In fully compliant 28 -day toxicity and OECD 421 studies the NOAEL was 1000 mg/kg/day, the highest dose level tested. In addition, the substance is not acutely toxic, is neither a skin or a eye irritant, and has no skin sensitising potential. No genotoxic potential was evidenced in available studies. The NOAEL of 1000 mg/kg/day has been used as the starting point for deriving systemic long-term DNELs and is considered sufficiently protective for the general population.