Registration Dossier
Registration Dossier
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EC number: 418-370-0 | CAS number: 143925-92-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.76 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:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 44.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Due to lack of repeated dose toxicity data by the inhalation route, a route to route extrapolation was performed. The NOAEL (oral) is converted into a NOAEC (corrected) in accordance to guidance on information requirements and chemical safety assessment, Chapter R.8, ECHA, May 2008. The NOAEL (oral) has to be divided by a factor of 0.38 m³/kg body weight and corrected for activity driven differences of respiratory volumes in workers compared to workers in rest (6.7 m³/10 m³). In addition, a default factor of 2 is applied to account for differences in oral and inhalative absorption properties. The corrected starting point is therefore:
NOAEC (corrected) = 50 mg/kg / 0.38 m³/kg x 0.5 x (6.7 m³/10m³) = 44.1 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable; therefore, no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is part of the route to route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- standard factor for remaining uncertainties
- AF for intraspecies differences:
- 5
- Justification:
- standard factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- GLP and guideline compliant study
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
- 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:
- 0.5 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The dermal route is typically covered by oral route information in the absence of data for this administration route. Since the test article is expected to penetrate the skin, an absorption ratio of 100% is assumed as worst case scenario.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable; therefore, no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- extrapolation from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- standard factor for remaining uncertainties
- AF for intraspecies differences:
- 5
- Justification:
- standard factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- GLP-compliant guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The NOAEL of 50 mg/kg body weight obtained in the subchronic toxicity study with rats was used as starting point for DNEL calculations following a worst case approach.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.43 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:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 21.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Because no inhalation study is available, a route to route extrapolation was performed. The NOAEL (oral) has to be modified into a NOAEC (corrected) in accordance to guidance on information requirements and chemical safety assessment, Chapter R.8, ECHA, May 2008. Here, the NOAEL has to be divided by a factor of 1.15 m³/kg body weight resulting in a corrected starting point of 21.7 mg/m³per day.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable; therefore, no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is part of the route to route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- standard factor for remaining uncertainties
- AF for intraspecies differences:
- 10
- Justification:
- standard factor for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- GLP and guideline compliant study
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
- 0.25 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:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The dermal route is typically covered by oral route information in the absence of data for this administration route. Since the test article is expected to penetrate the skin, an absorption ratio of 100% is assumed as worst case scenario.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable; therefore, no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- extrapolation from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- standard factor for remaining uncertainties
- AF for intraspecies differences:
- 10
- Justification:
- standard factor for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- GLP-compliant guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
- 0.25 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:
- 50 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable; therefore, no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- extrapolation from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- standard factor for remaining uncertainties
- AF for intraspecies differences:
- 10
- Justification:
- standard factor for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- GLP-compliant guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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
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.
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