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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 248-597-9 | CAS number: 27676-62-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 70.53 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763.16 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Exposure data only available from oral exposure.
- AF for dose response relationship:
- 1
- Justification:
- Table R8-6
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic. Table R8-6
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is accounted for in NOAEL extrapolation
- AF for intraspecies differences:
- 5
- Justification:
- workers. Table R8-6
- AF for the quality of the whole database:
- 1
- Justification:
- data reliable. Table R8-6
- AF for remaining uncertainties:
- 2.5
- Justification:
- Table R8-6
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:
- 10 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Exposure data only available from oral exposure.
- AF for dose response relationship:
- 1
- Justification:
- Table R8-6
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic. Table R8-6
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human. Table R8-3
- AF for intraspecies differences:
- 5
- Justification:
- workers. Table R8-6
- AF for the quality of the whole database:
- 1
- Justification:
- data reliable. Table R8-6
- AF for remaining uncertainties:
- 2.5
- Justification:
- Table R8-6
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Dermal NOAEL
Corrected dermal (oral -> dermal)
Based on Appendix R. 8-2, Example B.5, as a worst case it is assumed that 100% adsorption orally to rats and by dermal adsorption to human are equivalent.
NOAEL (dermal) = oral NOAEL * ABS oral-rat/ABS derm-human
NOAEL (dermal) = 1000 * 100/100 = 1000
NOAEL (dermal) = 1000 mg/kg/day.
Inhalation NOAEL
Based on formulae in R. 8-3, as a worst case it is assumed 100% adsorption orally to rats and by inhalation to human are equivalent. The granulometry data for this substance indicates that the substance is not respirable by humans; the vapour pressure of the substance is extremely low indicating the substance is non-volatile. Target endpoints are also assumed to be equivalent.
For workers (8h exposure/d)
NOAEC (inhal) = oral NOAEL * 1/0.38m3/kg/d * ABS oral-rat/ABS inh-human * 6.7m3/10m3
NOAEC (inhal) = 1000 * 1/0.38 m3/kg/d * 100/100 * 6.7m3/10m3= 1763.16
NOAEC (inhal) = 1763.16 mg/m3
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17.39 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 869.57 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Exposure data only available from oral exposure
- AF for dose response relationship:
- 1
- Justification:
- Table R8-6
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic. Table R8-6
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is accounted for in NOAEL extrapolation
- AF for intraspecies differences:
- 10
- Justification:
- general population. Table R8-6
- AF for the quality of the whole database:
- 1
- Justification:
- data reliable. Table R8-6
- AF for remaining uncertainties:
- 2.5
- Justification:
- Table R8-6
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:
- 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Exposure data only available from oral exposure.
- AF for dose response relationship:
- 1
- Justification:
- Table R8-6
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic. Table R8-6
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human. Table R8-3
- AF for intraspecies differences:
- 10
- Justification:
- general population. Table R8-6
- AF for the quality of the whole database:
- 1
- Justification:
- data reliable. Table R8-6
- AF for remaining uncertainties:
- 2.5
- Justification:
- Table R8-6
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:
- 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Table R8-6
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic. Table R8-6
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human. Table R8-3
- AF for intraspecies differences:
- 10
- Justification:
- general population. Table R8-6
- AF for the quality of the whole database:
- 1
- Justification:
- data reliable. Table R8-6
- AF for remaining uncertainties:
- 2.5
- Justification:
- Table R8-6
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
Dermal NOAEL
Corrected dermal (oral -> dermal)
Based on Appendix R. 8-2, Example B.5, as a worst case it is assumed that 100% adsorption orally to rats and by dermal adsorption to human are equivalent.
NOAEL (dermal) = oral NOAEL * ABS oral-rat/ABS derm-human
NOAEL (dermal) = 1000 * 100/100 = 1000
NOAEL (dermal) = 1000 mg/kg/day.
Inhalation NOAEL
Based on formulae in R. 8-3, as a worst case it is assumed 100% adsorption orally to rats and by inhalation to human are equivalent. The granulometry data for this substance indicates that the substance is not respirable by humans; the vapour pressure of the substance is extremely low indicating the substance is non-volatile. Target endpoints are also assumed to be equivalent.
For general population (24h exposure/d)
NOAEC (inhal) = oral NOAEL * 1/1.15m3/kg/d * ABS oral-rat/ABS inh-human
NOAEC (inhal) = 1000 * 1/1.15 m3/kg/d * 100/100 = 869.57
NOAEC (inhal) = 869.57 mg/m3
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