Registration Dossier
Registration Dossier
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EC number: 220-780-8 | CAS number: 2897-60-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 23.5 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEL (oral): Correction respiratory volume rat (8 hour) 1/0.38 m3/kg bw/day, Correction for respiratory volume (worker): 6.7 m3/10 m3. Therefore, the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: oral 1000 mg/kg bw/day*(1/0.38) *(6.7 m3/10 m3) = 1763 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (oral to inhaled)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default (guideline study)
- AF for remaining uncertainties:
- 1
- Justification:
- Default (no remaining uncertainties)
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:
- 3.33 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (oral to dermal)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default (guideline study)
- AF for remaining uncertainties:
- 1
- Justification:
- Default (no remaining uncertainties)
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:
- 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:
- 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 870 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEL (oral): Correction respiratory volume rat (24 hour) 1/1.15 m3/kg bw. Therefore, the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: oral 1000 mg/kg bw/day*(1/1.15) = 870 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (oral to inhaled)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default (guideline study)
- AF for remaining uncertainties:
- 1
- Justification:
- Default (no remaining uncertainties)
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:
- no hazard identified
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:
- 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:
- 1.67 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (oral to oral)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default (guideline study)
- AF for remaining uncertainties:
- 1
- Justification:
- Default (no remaining uncertainties)
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
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