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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 274-570-6 | CAS number: 70321-86-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.56 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:
- 39 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The substance is stable in stomach acid. As it is poorly soluble, uptake after inhalation will be predominantly oral (after mucus transport and swallowing)
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Included in route-to-route extrapolation
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 2.5
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.22 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:
- 22 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The substance is expected to be poorly absorbed both after ingestion and skin contact. Absorption via the skin will be less since the substance is insoluble in water.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 2.5
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
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
1. Identification of relevant dose descriptor
For the derivation of the DNELs, the 90-Day oral toxicity study in rats was qualified as the most relevant study. The dose descriptor chosen was the NOAEL of 22 mg/kg/day.
2. Mode of action
No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic and no sensitizing potential. It is not teratogenic in rats. It is not irritating to skin and eyes.
3. Correction of dose descriptor
NOAEL (oral) is converted into a NOAEL(corrected)in accordance to Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose[concentration]-response for human health, ECHA, May 2008.
Workers: NOAEL (oral) = 22 mg/kg bw =>NOAEL(corrected)= 39 mg/m3
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.38 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:
- 19 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The substance is stable in stomach acid. As it is poorly soluble, uptake after inhalation will be predominantly oral (after mucus transport and swallowing)
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic study available
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- included in route-to-route extrapolation
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 2.5
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.11 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:
- 22 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The substance is expected to be poorly absorbed both after ingestion and skin contact. Absorption via the skin will be less since the substance is insoluble in water.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 2.5
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:
- 0.11 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:
- 22 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
no route-to-route extrapolation performed
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 2.5
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
1. Identification of relevant dose descriptor
For the derivation of the DNELs, the 90-Day oral toxicity study in rats was qualified as the most relevant study. The dose descriptor chosen was the NOAEL of 22 mg/kg/day.
2. Mode of action
No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.
It is not irritating and not skin sensitizing.
3. Correction of dose descriptor
NOAEL (oral) is converted into a NOAEL(corrected)in accordance to Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose[concentration]-response for human health, ECHA, May 2008.
general population: NOAEL (oral) = 22 mg/kg bw =>NOAEL(corrected)= 19 mg/m3
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