Registration Dossier
Registration Dossier
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EC number: 203-639-5 | CAS number: 109-01-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.7 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):
- 62.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 190 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 167.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Key toxic endpoint was in the OECD 422 study with rats, the NOAEL was 190 mg/kg bw/d.
Oral absorption of the rat/inhalation absorption of humans (ABS oral-rat/ABS inh-human): 50/100
Standard respiratory volume of the rat (sRVrat) for 8 hours: 0.38 m³/kg bw/day
Standard respiratory volume of humans (sRVhuman) for 8 hours: 6.7 m³
Worker respiratory volume (wRV) for 8 hours with light physical activity: 10 m³
Corrected NOAEC (inhalation) for workers: NOAECcorr. = 190 mg/kg bw/d x 0.5 x (1/0.38 m³/kg bw/day) x (6.7 m³/10m³) = 167.5 mg/m³- AF for dose response relationship:
- 1
- Justification:
- Effects show a clear dose response so factor of 1 used.
- AF for differences in duration of exposure:
- 5
- Justification:
- ECHA guidance document Chapter R8, in Appendix R.8-12, indicates that DNELS derived using a NOAEL from a 28 day study are derived using an assessment factor of 6 with a 90 day study using an assessment factor of 2 for extrapolation of the study duration to chronic exposure. This OECD 422 was 43 days for males and at least 43 days for females, therefore a factor of 5 has been selected.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is already included in the route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA guidelines require a factor of 2.5 for other interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- ECHA guidance requires a factor of 5 for intraspecies differnces bewteen workers.
- AF for the quality of the whole database:
- 1
- Justification:
- The OECD 422 toxicity study was conducted according to regulatory standards and was adequately reported. On this basis the quality of the database is not considered to contribute uncertainty and it is therefore not necessary to apply an additional factor.
- AF for remaining uncertainties:
- 1
- Justification:
- All uncertainties are already included so a factor of 1 is applied.
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- 0.76 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):
- 250
- Dose descriptor starting point:
- NOAEL
- Value:
- 190 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Key toxic endpoint was in the OECD 422 study with rats, the NOAEL was 190 mg/kg bw/d.
- AF for dose response relationship:
- 1
- Justification:
- Effects show a clear dose response so factor of 1 used.
- AF for differences in duration of exposure:
- 5
- Justification:
- ECHA guidance document Chapter R8, in Appendix R.8-12, indicates that DNELS derived using a NOAEL from a 28 day study are derived using an assessment factor of 6 with a 90 day study using an assessment factor of 2 for extrapolation of the study duration to chronic exposure. This OECD 422 was 43 days for males and at least 43 days for females, therefore a factor of 5 has been selected.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- A factor of 4 is applied based on ECHA guidance for allometric scaling of data from rats to humans.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 is applied based on ECHA guidance for the assessment factor for other inter species differences.
- AF for intraspecies differences:
- 5
- Justification:
- The ECHA guideline give an assessment factor of 5 for intra species differences between workers.
- AF for the quality of the whole database:
- 1
- Justification:
- The OECD 422 toxicity study was conducted according to regulatory standards and was adequately reported. On this basis the quality of the database is not considered to contribute uncertainty and it is therefore not necessary to apply an additional factor.
- AF for remaining uncertainties:
- 1
- Justification:
- All uncertainties are already included so a factor of 1 is applied.
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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
Since no exposure is intended for the general population, no DNELs were derived.
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