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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.24 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
Modified dose descriptor starting point:
NOAEC
Value:
35 mg/m³
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to inhalation NOAEC: 1000 mg/kg/day x [1/0.38 x 2/100 x 6.7/10] = 35 mg/m3
AF for dose response relationship:
1
Justification:
No adverse effects observed in repeat dose, reproductive toxicity studies, or genetox
AF for differences in duration of exposure:
6
Justification:
Default factor for subacute to chronic study extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
Already taken into account during the correction of starting point
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining toxicodynamic differences
AF for intraspecies differences:
5
Justification:
Default factor for workers
AF for the quality of the whole database:
2
Justification:
Based on read across, single species used in repro developmental and repeat dose toxicity studies
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:
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
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
NOAEL: 1000 x 1 (oral absorption = dermal absorption) = 1000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
No adverse effects observed in repeat dose, reproductive toxicity studies, or genetox
AF for differences in duration of exposure:
6
Justification:
Default factor for subacute to chronic study extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor for extrapolating toxicokinetics from Rat to Human
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining toxicodynamic differences
AF for intraspecies differences:
5
Justification:
Default factor for workers
AF for the quality of the whole database:
2
Justification:
Based on read across, single species used in repro developmental and repeat dose toxicity studies.
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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.06 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):
300
Modified dose descriptor starting point:
NOAEC
Value:
17 mg/m³
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to inhalation NOAEC: 1000 mg/kg/day x [(1/1.15) x (2/100)] = 17 mg/m3
AF for dose response relationship:
1
Justification:
No adverse effects observed in repeat dose, reproductive toxicity studies, or genetox
AF for differences in duration of exposure:
6
Justification:
Default factor for subacute to chronic study extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
Already taken into account during the correction of starting point
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining toxicodynamic differences
AF for intraspecies differences:
10
Justification:
Default factor for the general population
AF for the quality of the whole database:
2
Justification:
Based on read across, single species used in repro developmental and repeat dose toxicity studies.
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:
0.8 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):
1 200
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
NOAEL: 1000 x 1 (oral absorption = dermal absorption) = 1000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
No adverse effects observed in repeat dose, reproductive toxicity studies, or genetox
AF for differences in duration of exposure:
6
Justification:
Default factor for subacute to chronic study extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor for extrapolating toxicokinetics from Rat to Human
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining toxicodynamic differences
AF for intraspecies differences:
10
Justification:
Default factor for the general population
AF for the quality of the whole database:
2
Justification:
Based on read across, single species used in repro developmental and repeat dose toxicity studies.
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:
0.8 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):
1 200
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
NOAEL: 1000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
No adverse effects observed in repeat dose, reproductive toxicity studies, or genetox
AF for differences in duration of exposure:
6
Justification:
Default factor for subacute to chronic study extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor for extrapolating toxicokinetics from Rat to Human
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining toxicodynamic differences
AF for intraspecies differences:
10
Justification:
Default factor for general population
AF for the quality of the whole database:
2
Justification:
Based on read across, single species used in repro developmental and repeat dose toxicity studies.
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