Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 435-740-7 | CAS number: 94317-64-3
Toxicological information
Toxicological Summary
Currently viewing:
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
