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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 248-468-7 | CAS number: 27458-90-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 32.9 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2 468.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
DNEL derivation is based on a 4-week toxicity study by oral daily administration to rats (Papineau, 2017).
The starting dose for DNEL calculation was a NOAEL higher than 1000 mg/kg/day for systemic toxicity.
Similar absorption rates were assumed for the oral and inhalation routes.
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL generation plugin)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL generation plugin)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL generation plugin)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for remaining uncertainties:
- 1
- Justification:
- Default
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:
- 46.7 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 14 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
DNEL derivation is based on a 4-week toxicity study by oral administration to rats (Papineau, 2017). The starting dose for DNEL calculation was a NOAEL higher than 1000 mg/kg/day for systemic toxicity. Default absorption rates of 100 and 10% are assumed for the oral and dermal routes, respectively.
The NAEL (8h) derived for workers is 14000 mg/kg bw/d after correction for difference between skin vs oral absorption and duration of exposure (7 days vs. 5 days/week) (1000 mg/kg bw * 100/10 * 7d/5d).
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL generation plugin)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL generation plugin)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL generation plugin)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL generation plugin)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for remaining uncertainties:
- 1
- Justification:
- Default
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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.8 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 869.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
DNEL derivation is based on a 4-week toxicity study by oral daily administration to rats (Pazpineau, 2017).
The starting dose for DNEL calculation was a NOAEL higher than 1000 mg/kg/day for systemic toxicity.
Default absorption rate of 100% is assumed for both the oral and inhalation routes.
The NAEC (8h) derived for general population is 869.6 mg/m3 (1000 mg/kg bw / 1.15 m3/kg bw).
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL generation plugin)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL generation plugin)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL generation plugin)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL generation plugin)
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:
- 16.7 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
DNEL derivation is based on a 4-week toxicity study by oral administration to rats (Papineau, 2017). The starting dose for DNEL calculation was a NOAEL higher than 1000 mg/kg/day for systemic toxicity.
Default absorption rates of 100 and 10% are assumed for the oral and dermal routes, respectively.
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL generation plugin)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL generation plugin)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL generation plugin)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL generation plugin)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL generation plugin)
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:
- 1.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL generation plugin)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL generation plugin)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL generation plugin)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL generation plugin)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL generation plugin)
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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