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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
41.2 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):
42.5
Modified dose descriptor starting point:
NOAEC
Value:
1 750 mg/m³
Explanation for the modification of the dose descriptor starting point:
NAEC: [(1000/4) x 70)/10]; NOAEL = 30 mg/kg on dog (Salvador, 2013); 4 = allometric scaling factor rat; 70 kg/bw= standard human body weight; 10 m^3/person= default human breathing volume for workers in 8 h.
AF for dose response relationship:
1
Justification:
No scaling needed
AF for differences in duration of exposure:
3.4
Justification:
ERASM Project: lower factor found based on RepDose study (factor 3.4 instead of 6 from subacute to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling needed because the starting point (NAEC) has just been corrected for the human evaluation.
AF for other interspecies differences:
2.5
Justification:
Toxicocinetic and toxicodynamic differences
AF for intraspecies differences:
5
Justification:
Human Worker
AF for the quality of the whole database:
1
Justification:
GLP compliant, recent data on the registered substance
AF for remaining uncertainties:
1
Justification:
100% adsorption for inhalative route for animal and humanis assumed
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
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:
59 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):
170
Modified dose descriptor starting point:
NOAEL
Value:
10 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
10% adsorption for dermal route compaired to oral route is assumed. NOAEL is corrected for route to route extrapolation
AF for dose response relationship:
1
Justification:
No scaling needed
AF for differences in duration of exposure:
3.4
Justification:
ERASM Project: lower factor found based on RepDose study (factor 3.4 instead of 6 from subacute to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Rat
AF for other interspecies differences:
2.5
Justification:
Toxicocinetic and toxicodynamic differences
AF for intraspecies differences:
5
Justification:
Human worker
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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
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:
10.2 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):
85
Modified dose descriptor starting point:
other: NAEC
Value:
875 mg/m³
Explanation for the modification of the dose descriptor starting point:
NAEC= ((1000 /4) x 70) /20; NOAEL = 100 mg/kg on rat (Salvador, 2013); 4 = allometric scaling factor rat; 70 kg/bw= standard human body weight; 20 m^3/person= default human breathing volume for general population 24h.
AF for dose response relationship:
1
Justification:
No scaling needed
AF for differences in duration of exposure:
3.4
Justification:
ERASM Project: lower factor found based on RepDose study (factor 3.4 instead of 6 from subacute to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling needed because the starting point (NAEC) has just been corrected for the human evaluation.
AF for other interspecies differences:
2.5
Justification:
Toxicocinetic and toxicodynamic differences
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Justification:
100% adsorption for inhalative route for animal and humanis assumed
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
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:
29 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):
340
Modified dose descriptor starting point:
NOAEL
Value:
10 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
10% adsorption for dermal route compaired to oral route is assumed. NOAEL is corrected for route to route extrapolation
AF for dose response relationship:
1
Justification:
No scaling needed
AF for differences in duration of exposure:
3.4
Justification:
ERASM Project: lower factor found based on RepDose study (factor 3.4 instead of 6 from subacute to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
Toxicocinetic and toxicodynamic differences
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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
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:
2.9 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):
340
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No modification necessary
AF for dose response relationship:
1
Justification:
No scaling needing
AF for differences in duration of exposure:
3.4
Justification:
ERASM Project: lower factor found based on RepDose study (factor 3.4 instead of 6 from subacute to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Rat
AF for other interspecies differences:
2.5
Justification:
Toxicocinetic and toxicodynamic differences
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Justification:
100% adsorption for oral route for animal and human is assumed
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population