Registration Dossier
Registration Dossier
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EC number: 939-581-9 | CAS number: 1471314-81-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10.58 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 264.47 mg/m³
- Explanation for the modification of the dose descriptor starting point:
As no long-term study on inhalation is available, route-to-route extrapolation has been performed (oral to inhalation).
The NOAEL (oral route) observed in an Extended One-Generation Reproductive Toxicity Study, performed according to OECD 443 guideline (Barraclough, 2021), was used to derive a DNEL long-term, systemic effects via the inhalation route. The NOAEL was established to be 150 mg/kg bw/day.
The oral NOAEL dose in rats is converted to the corresponding air concentrations using a standard breathing volume for the rat (0.38 m³/kg bw for 8 hours, as this is the expected duration of worker exposure). The resulting air concentration needs to be additionally corrected for the difference between basal caloric demand and caloric demand under light activity for workers. This correction factor is derived from the inhaled volumes during an 8-hour period under the respective conditions (6.70 m³ for base level, 10 m³ for light activity). No correction factor for bioavailability is required as bioavailability after oral and inhalatory administration is assumed to be 100%. The corrected inhalation NOAEC is calculated as follows: 150 mg/kg bw/day x (1/(0.38 m³/kg bw/day)) x (6.70 m³/10 m³) = 264.47 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as the starting point, no additional assessment factor is required
- AF for differences in duration of exposure:
- 2
- Justification:
- difference in study duration, subchronic (121 days) to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Covered by calculation for route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor for worker population
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- Default assessment factor
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:
- 15 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
As no long-term study via dermal application is available, route-to-route extrapolation has been performed (oral to dermal).
The NOAEL (oral route) observed in an Extended One-Generation Reproductive Toxicity Study, performed according to OECD 443 guideline (Barraclough, 2021), was used to derive a DNEL long-term, systemic effects via the dermal route. The NOAEL was established to be 150 mg/kg bw/day. After route-to-route extrapolation from oral to dermal, the dose descriptor starting point is 150 mg/kg bw/day x 100%/10% = 1500 mg/kg bw/day. A correction factor of 10 is considered as bioavailability after oral administration is established to be 100%, and after dermal administration 10%.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as the starting point, no additional assessment factor is required
- AF for differences in duration of exposure:
- 2
- Justification:
- difference in study duration, subchronic (121 days) to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- default assessment factor
- AF for intraspecies differences:
- 5
- Justification:
- worker population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
- 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:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium 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:
- 2.61 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 130.43 mg/m³
- Explanation for the modification of the dose descriptor starting point:
This route is considered of minor concern due to the low vapour pressure of the substance. In addition, the substance is marketed as a water solution.
As no long-term study on inhalation is available, route-to-route extrapolation has been performed (oral to inhalation).
The NOAEL (oral route) observed in an Extended One-Generation Reproductive Toxicity Study, performed according to OECD 443 guideline (Barraclough, 2021), was used to derive a DNEL long-term, systemic effects via the inhalation route. The NOAEL was established to be 150 mg/kg bw/day.
The oral NOAEL dose in rats is converted to the corresponding air concentrations using a standard breathing volume for the rat (1.15 m³/kg for 24 hours as this is the expected duration exposure for consumers). No correction factor for bioavailability is required as bioavailability after oral and inhalatory administration is assumed to be 100%. The corrected inhalation NOAEC is calculated as follows: 150 mg/kg bw/day x 1/(1.15 m³/kg bw/day) = 130.43 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as the starting point, no additional assessment factor is required.
- AF for differences in duration of exposure:
- 2
- Justification:
- difference in study duration, subchronic (121 days) to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Covered by calculation for route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- Default assessment factor
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:
- 7.5 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
As no long-term study via dermal application is available, route-to-route extrapolation has been performed (oral to dermal).
The NOAEL (oral route) observed in an Extended One-Generation Reproductive Toxicity Study, performed according to OECD 443 guideline (Barraclough, 2021), was used to derive a DNEL long-term, systemic effects via the dermal route. The NOAEL was established to be 150 mg/kg bw/day. After route-to-route extrapolation from oral to dermal, the dose descriptor starting point is 150 mg/kg bw/day x 100%/10% = 1500 mg/kg bw/day. A correction factor of 10 is considered as bioavailability after oral administration is established to be 100%, and after dermal administration 10%.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as the starting point, no additional assessment factor is required
- AF for differences in duration of exposure:
- 2
- Justification:
- difference in study duration, subchronic (121 days) to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
- 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:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.75 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No correction is needed for route-to-route extrapolation in this case. The NOAEL (oral route) observed in an Extended One-Generation Reproductive Toxicity Study, performed according to OECD 443 guideline (Barraclough, 2021), was used to derive a DNEL long-term, systemic effects via the oral route. The NOAEL was established to be 150 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as the starting point, no additional assessment factor is required
- AF for differences in duration of exposure:
- 2
- Justification:
- difference in study duration, subchronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
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:
- medium hazard (no threshold derived)
Additional information - General Population
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.
