Registration Dossier
Registration Dossier
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EC number: 200-875-0 | CAS number: 75-50-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.94 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):
- 75
- Dose descriptor starting point:
- NOAEC
- Value:
- 588.5 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 295.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
In the study of Kinney et al., 1990, an inhalatory NOAEC systemic of 240 ppm (= 588.5 mg/m³) was determined.
Rats were exposed for 6 h/d for 14 days.
Accordingly, the calculation for the modified starting point for workers is:
NOAEC corr = 588.5 mg/m³ * (6h/d / 8h/d) * (6.7m³/10m³)
- AF for dose response relationship:
- 1
- Justification:
- The default value is applied.
- AF for differences in duration of exposure:
- 6
- Justification:
- The recommended AF for subchronic to chronic is applied.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already included in route to route extrapolation/ modification of starting point.
- AF for other interspecies differences:
- 2.5
- Justification:
- The recommended AF for other interspecies differences is applied.
- AF for intraspecies differences:
- 5
- Justification:
- The default value for the group "worker" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.9 mg/m³
DNEL related information
- DNEL derivation method:
- other: OEL value derived i.a. by SCOEL, MAK
- Overall assessment factor (AF):
- 1
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 1
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.8 mg/m³
DNEL related information
- DNEL derivation method:
- other: OEL value derived i.a. by SCOEL, MAK
- Overall assessment factor (AF):
- 1
- DNEL extrapolated from long term DNEL
- AF for dose response relationship:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 1
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Workers - 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:
- medium hazard (no threshold derived)
DNEL related information
- Justification:
- default value
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
Calculation of Consumer DNELs not relevant, since no uses for consumers are intended.
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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