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EC number: 220-449-8 | CAS number: 2768-02-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 27.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 11
- Dose descriptor starting point:
- NOAEC
- Value:
- 605 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 304.01 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEC (inhalation): Correction for experimental exposure duration (6 h/d to 8 h/d), Correction for respiratory volume (worker): 6.7 m3/10 m3. Therefore, the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 605*(6 h/ 8 h) *(6.7 m3/10 m3) = 304.01 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default, NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- Default, subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default, inhalation rat to inhalation human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 2.2
- Justification:
- Substance-specific intraspecies assessment factor (see Section 7.1 Toxicokinetics)
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 73.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5.5
- DNEL extrapolated from long term DNEL
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:
- 0.91 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):
- 44
- Dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No correction was made to the dose descriptor starting point.
- AF for dose response relationship:
- 1
- Justification:
- Default, NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Default, subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default, oral rat to dermal human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 2.2
- Justification:
- Substance-specific intraspecies assessment factor (see Section 7.1 Toxicokinetics)
- 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:
- 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:
- 6.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 16
- Dose descriptor starting point:
- NOAEC
- Value:
- 605 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 108 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEC (inhalation): Correction for exposure duration (6 h/d to 24 h/d), correction for dosing frequency: 5 d/wk to 7 d/wk. Therefore, the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 605 * (6/24) * (5/7) = 108.0 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- Default, NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- Default, subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default, inhalation rat to inhalation human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 3.2
- Justification:
- Substance-specific intraspecies assessment factor (see Section 7.1 Toxicokinetics)
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 54.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 8
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- DNEL extrapolated from long term DNEL
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.63 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):
- 64
- Dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No correction was made to the dose descriptor starting point.
- AF for dose response relationship:
- 1
- Justification:
- Default, NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Default, subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default, oral rat to dermal human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 3.2
- Justification:
- Substance-specific intraspecies assessment factor (see Section 7.1 Toxicokinetics)
- 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:
- 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:
- 0.63 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):
- 64
- Dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No correction was applied to the dose descriptor starting point.
- AF for dose response relationship:
- 1
- Justification:
- Default, NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Default, subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default, oral rat to oral human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 3.2
- Justification:
- Substance-specific intraspecies assessment factor (see Section 7.1 Toxicokinetics)
- 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
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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