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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 946-103-2 | CAS number: -
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 6
- Dose descriptor starting point:
- NOAEL
- Value:
- 50.3 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- (ECHA guidance R.8)
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute versus chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not relevant for local effects (ECHA guidance R.8)
- AF for other interspecies differences:
- 1
- Justification:
- Rats are more susceptible to lung overloading of PSP compared to humans (ECETOC TR No. 122 p.85)
- AF for intraspecies differences:
- 1
- Justification:
- Rats are more susceptible to lung overloading of PSP compared to humans (ECETOC TR No. 122 p.85-86)
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor for studies performed according to OECD and GLP (ECHA guidance R.8)
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor (ECHA guidance R.8)
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:
- 1.6 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 6
- Dose descriptor:
- NOAEC
- Value:
- 10.3 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- (ECHA guidance R.8)
- AF for differences in duration of exposure:
- 36
- Justification:
- subacute versus chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not relevant for local effects (ECHA guidance R.8)
- AF for other interspecies differences:
- 1
- Justification:
- Rats are more susceptible to lung overloading of PSP compared to humans (ECETOC TR No. 122 p.85)
- AF for intraspecies differences:
- 1
- Justification:
- Rats are more susceptible to lung overloading of PSP compared to humans (ECETOC TR No. 122 p.85-86)
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor for studies performed according to OECD and GLP (ECHA guidance R.8)
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor (ECHA guidance R.8)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 53.1 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- other: LC50
- Value:
- 5 310 mg/m³
- AF for dose response relationship:
- 100
- Justification:
- A default AF of 100 is suggested (ECHA guidance R.8)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not relevant for local effects (ECHA guidance R.8)
- AF for other interspecies differences:
- 1
- Justification:
- Rats are more susceptible to lung overloading of PSP compared to humans (ECETOC TR No. 122 p.85)
- AF for intraspecies differences:
- 1
- Justification:
- Rats are more susceptible to lung overloading of PSP compared to humans (ECETOC TR No. 122 p.85-86)
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor for studies performed according to OECD and GLP (ECHA guidance R.8)
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor (ECHA guidance R.8)
Workers - Hazard via dermal 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:
- no hazard identified
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:
- no hazard identified
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:
- 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:
- 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
General Population - Hazard via oral 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
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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.
