Registration Dossier
Registration Dossier
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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: 812-927-5 | CAS number: 1902936-62-2
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.8 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor:
- LOAEC
- Value:
- 750
- AF for dose response relationship:
- 2
- Justification:
- EC3 value could be derived and additional uncertainties are covered with high interspecies differences assessment factor. While EC3 value can be considered a LOAEC, several publications argued it to be very close to a human NOAEC. Therefore, an assessment factor of 2 was considered adequate.
- AF for differences in duration of exposure:
- 1
- Justification:
- complete induction timeframe is covered in the LLNA, furthermore differences in exposure conditions are covered in the skin sensitization specific assessment factors
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required since the effect assessed is a local effect
- AF for other interspecies differences:
- 10
- Justification:
- default assessment factor according to ECHA Guidance R.8
- AF for intraspecies differences:
- 5
- Justification:
- default assessment factor according to ECHA Guidance R.8
- AF for the quality of the whole database:
- 1
- Justification:
- Guideline, GLP study
- AF for remaining uncertainties:
- 2
- Justification:
- Skin sensitization specific assessment factors:
AF for vehicle or matrix effect: 1 (for justification, please refer to attachment in IUCLID Chapter 13 and CSR)
AF for different exposure conditions: 2 (for justification, please refer to attachment in IUCLID Chapter 13 and CSR)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.8 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- other: EC3
- Value:
- 750
- AF for dose response relationship:
- 2
- Justification:
- EC3 value could be derived and additional uncertainties are covered with high interspecies differences assessment factor. While EC3 value can be considered a LOAEC, several publications argued it to be very close to a human NOAEC. Therefore, an assessment factor of 2 was considered adequate.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required since the effect assessed is a local effect
- AF for other interspecies differences:
- 10
- Justification:
- default assessment factor according to ECHA Guidance R.8
- AF for intraspecies differences:
- 5
- Justification:
- default assessment factor according to ECHA Guidance R.8
- AF for the quality of the whole database:
- 1
- Justification:
- Guideline, GLP study
- AF for remaining uncertainties:
- 2
- Justification:
- Skin sensitization specific assessment factors:
AF for vehicle or matrix effect: 1 (for justification, please refer to attachment in IUCLID Chapter 13 and CSR)
AF for different exposure conditions: 2 (for justification, please refer to attachment in IUCLID Chapter 13 and CSR)
General Population - Hazard via oral route
Systemic 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 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.
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.
