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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 219-708-8 | CAS number: 2503-73-3
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:
- 2.939 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 220.395 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- NOAEL/NOAEC is used as a starting point for the DNEL derivation
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on RDT-28 day
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is usually not applied in the derivation of the inhalation DNEL.
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- Justification:
- For workers
- AF for the quality of the whole database:
- 1
- Justification:
- Reliability 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
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)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.33 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 500 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL/NOAEC is used as a starting point for the DNEL derivation
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on RDT-28 day
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- Justification:
- For workers
- AF for the quality of the whole database:
- 1
- Justification:
- Reliability 1
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.725 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 108.696 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- NOAEL/NOAEC is used as a starting point for the DNEL derivation
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on RDT 28 day
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is usually not applied in the derivation of the inhalation DNEL.
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- For general population
- AF for the quality of the whole database:
- 1
- Justification:
- Reliability 1
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
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)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.167 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
As the Kow < -2.5 and MW is 1055.906 it means for CSA only 10% absorption by dermal route.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL/NOAEC is used as a starting point for the DNEL derivation
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL id based on RDT 28 day study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- for RAT
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Reliability 1
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
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)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.416 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL/NOAEC is used as a starting point for the DNEL derivation
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on RDT 28 days study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- for RAT
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Reliability 1
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
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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