Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.63 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
37.5
Dose descriptor starting point:
NOAEL
Value:
18 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
23.61 mg/m³
Explanation for the modification of the dose descriptor starting point:

Parameter Value Unit Rationale Possible values
Oral NOAEL (rat) 18 mg/kg bw/day lowest NOAEL (males) from OECD 416  
Oral absorption (rat) 74.39 % based on a metabolism study in rat  
Inhalation absorption (human) 100 % default R.8.4.2  
Rat respiratory volume 0.38 m3/kg 8h default (Table R.8-2) 0.29 (6h), 0.38 (8h), 1.15 (24h)
Human respiratory volume 6.7 m3/pers 8h defaut (Table R.8-2) 5 (6h), 6.7 (8h), 20 (24h)
Worker respiratory volume 10 m3 8h default (light work Table R.8-2) 10
Corrected inhalatory N(L)OAEC worker 23.61 mg/m3 calculation  
AF for dose response relationship:
3
Justification:
Severity of the effects (repro classification).
AF for differences in duration of exposure:
1
Justification:
2-generation study.
AF for other interspecies differences:
2.5
Justification:
Standard default assessment factor given in ECHA guidance.
AF for intraspecies differences:
5
Justification:
Standard default assessment factor given in ECHA guidance.
AF for the quality of the whole database:
1
Justification:
Standard default assessment factor given in ECHA guidance.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.12 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
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:
18 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
18 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Parameter Value Unit Rationale Possible values
Oral NOAEL (rat) 18 mg/kg bw/day lowest NOAEL (males) from OECD 416  
Oral absorption (rat) 74.39 % based on a metabolism study in rat  
Dermal absorption (human) 74.39 % by default, considered to be similar to oral absorption in rat  
Corrected dermal N(L)OAEL 18.00 mg/kg bw/day calculation  
AF for dose response relationship:
3
Justification:
Severity of the effects (repro classification).
AF for differences in duration of exposure:
1
Justification:
2-generation study.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard default assessment factor given in ECHA guidance.
AF for other interspecies differences:
2.5
Justification:
Standard default assessment factor given in ECHA guidance.
AF for intraspecies differences:
5
Justification:
Standard default assessment factor given in ECHA guidance.
AF for the quality of the whole database:
1
Justification:
Standard default assessment factor given in ECHA guidance.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

No dose-response information is provided in the available skin irritation study. Since the substance was non-irritating in the valid study, a DNEL for local dermal effects is deemed not necessary. Since the substance exhibited corrosive effects to the eyes, workers directly handling concentrated liquid or solid formulations must wear chemical-resistant safety goggles.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.155 mg/m³
Most sensitive endpoint:
effect on fertility
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:
18 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
11.64 mg/m³
Explanation for the modification of the dose descriptor starting point:

Parameter Value Unit Rationale Possible values
Oral NOAEL (rat) 18 mg/kg bw/day lowest NOAEL (males) from OECD 416  
Oral absorption (rat) 74.39 % based on a metabolism study in rat  
Inhalation absorption (human) 100 % default R.8.4.2  
Rat respiratory volume 1.15 m3/kg 24h default Table R.8-2 0.29 (6h), 0.38 (8h), 1.15 (24h)
Human respiratory volume 20 m3/pers 24h default Table R.8-2 5 (6h), 6.7 (8h), 20 (24h)
Corrected inhalatory N(L)OAEC Gen. pop. 11.64 mg/m3 calculation  
AF for dose response relationship:
3
Justification:
Severity of the effects (repro classification).
AF for differences in duration of exposure:
1
Justification:
2-generation study.
AF for other interspecies differences:
2.5
Justification:
Standard default assessment factor given in ECHA guidance.
AF for intraspecies differences:
10
Justification:
Standard default assessment factor given in ECHA guidance.
AF for the quality of the whole database:
1
Justification:
Standard default assessment factor given in ECHA guidance.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.06 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
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:
18 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
18 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Parameter Value Unit Rationale Possible values
Oral NOAEL (rat) 18 mg/kg bw/day lowest NOAEL (males) from OECD 416  
Oral absorption (rat) 74.39 % based on a metabolism study in rat  
Dermal absorption (human) 74.39 % by default, considered to be similar to oral absorption in rat  
Corrected dermal N(L)OAEL 18.00 mg/kg bw/day calculation  
AF for dose response relationship:
3
Justification:
Severity of the effects (repro classification).
AF for differences in duration of exposure:
1
Justification:
2-generation study.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard default assessment factor given in ECHA guidance.
AF for other interspecies differences:
2.5
Justification:
Standard default assessment factor given in ECHA guidance.
AF for intraspecies differences:
10
Justification:
Standard default assessment factor given in ECHA guidance.
AF for the quality of the whole database:
1
Justification:
Standard default assessment factor given in ECHA guidance.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.06 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
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:
18 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
18 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Parameter Value Unit Rationale Possible values
Oral NOAEL (rat) 18 mg/kg bw/day lowest NOAEL (males) from OECD 416  
Oral absorption (rat) 74.39 % based on a metabolism study in rat  
Oral absorption (human) 74.39 % by default, considered to be similar to rat  
Corrected oral N(L)OAEL 18.00 mg/kg bw/day calculation  
AF for dose response relationship:
3
Justification:
Severity of the effects (repro classification).
AF for differences in duration of exposure:
1
Justification:
2-generation study.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard default assessment factor given in ECHA guidance.
AF for other interspecies differences:
2.5
Justification:
Standard default assessment factor given in ECHA guidance.
AF for intraspecies differences:
10
Justification:
Standard default assessment factor given in ECHA guidance.
AF for the quality of the whole database:
1
Justification:
Standard default assessment factor given in ECHA guidance.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

The substance is used by agricultural industry to formulate fertilisers intended for professional use. Consumer exposure to the substance does not occur. The substance has no potential for bioaccumulation and secondary oral exposure to the substance is not relevant. It can be concluded that exposure of the general public to the substance is negligible.