Registration Dossier
Registration Dossier
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EC number: 407-130-0 | CAS number: 65232-89-5 BP AMOCO IV; E-326 CATALYST; KAT MSA; MSA-KATALYSATORTABLETTEN
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 56 µg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- Overall assessment factor (AF):
- 15
- Dose descriptor starting point:
- NOAEC
- Value:
- 1.69 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.85 mg/m³
- Explanation for the modification of the dose descriptor starting point:
6/8 : Correction for differences between exposure duration in animal study (6 hours/day) to length of workday for workers (8 hours/day)
6.7/10 : Correction for activity driven differences of respiratory volumes in workers at rest compared to workers at light activity (6.7 m3/10 m3)
- AF for dose response relationship:
- 1
- Justification:
- NOAEC is used as a starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- no allometric scalling has to be applied
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor
- AF for intraspecies differences:
- 3
- Justification:
- The assessment factor is introduced since it is expected that a greater variability in response from the most to least sensitive human would be seen, relative to an experimental animal population. ECETOC (2003) has reviewed scientific literature on the distribution of human data for various toxicokinetic and toxicodynamic parameters to assess intraspecies variability within the human population, specifically by Renwick and Lazarus (1998) and Hattis et al. (1999). Considering that the data analysed by these authors include both sexes, a variety of disease states and ages, the use of the 95th percentile of the distribution of the variability for these datasets is considered sufficiently conservative to account for intra-species variability for the general population. Based on this, a default assessment factor of 3 is recommended by ECETOC (2003) for workers.
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 15.1 µg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: AGW ("Arbeitsplatzgrenzwert") derived by German authorities. Details see section "Explanation for hazard conclusion"
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 15.1 µg/m³
DNEL related information
- DNEL derivation method:
- other: AGW ("Arbeitsplatzgrenzwert") derived by German authorities. Details see section "Explanation for hazard conclusion"
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- Overall assessment factor (AF):
- 15
- Dose descriptor starting point:
- NOAEC
- Value:
- 1.69 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 71.9 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAELdermal = NOAECinhal * (6/8) / ((1/0.38 m3/kg/d) * 0.67 * (ABSdermal / ABSinhal))
6/8 : Correction for differences between exposure duration in animal study (6 hours/day) to length of workday for workers (8 hours/day)
1/0.38 : Standard respiratory volume of a rat, corrected for 8 h exposure
0.67 : Correction for activity driven differences of respiratory volumes in workers at rest compared to workers at light activity (6.7 m3/10 m3)
ABSdermal / ABSinhal = 0.1 / 10
- AF for dose response relationship:
- 1
- Justification:
- NOAEC is used as a starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- no allometric scalling has to be applied
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor
- AF for intraspecies differences:
- 3
- Justification:
- The assessment factor is introduced since it is expected that a greater variability in response from the most to least sensitive human would be seen, relative to an experimental animal population. ECETOC (2003) has reviewed scientific literature on the distribution of human data for various toxicokinetic and toxicodynamic parameters to assess intraspecies variability within the human population, specifically by Renwick and Lazarus (1998) and Hattis et al. (1999). Considering that the data analysed by these authors include both sexes, a variety of disease states and ages, the use of the 95th percentile of the distribution of the variability for these datasets is considered sufficiently conservative to account for intra-species variability for the general population. Based on this, a default assessment factor of 3 is recommended by ECETOC (2003) for workers.
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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
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:
- no hazard identified
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:
- 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:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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
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