Registration Dossier
Registration Dossier
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EC number: 500-336-2 | CAS number: 157348-58-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.96 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 225 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 198 mg/m³
- Explanation for the modification of the dose descriptor starting point:
In order to derive the worker DNEL (long-term, inhalation, systemic), the NOAEL = 225.0 mg/kg bw/day assessed in the OECD 422 combined repeated dose toxicity study is used.
Converting the oral NOAEL rat into an inhalatory NOAEC rat is necessary to derive the correct starting point for the inhalation route for which no long term study was carried out.
Conversion of an rat NOAELoral; rep. dosefrom oral repeated dose toxicity study into an corrected rat NOAECinhal; rep.dose (derived from examples B.3 and Figure R. 8 -3; Appendix R 8-2 of TGD “Chapter R.8: Characterisation of dose [concentration]-response for human health”):
For worker:
assumptions:
ABS oral (rat) /ABS inhalation (human): 0.5 [ratio of oral absorption in the rat to inhalative absorption in the human]
corrected inhalatory NOAECinhal; rep. dose= oral NOAELoral; rep.dose* 1 / sRVrat * (ABSoral-rat/ABSinhal-human) * (sRVhuman / wRVhuman)
= 225 mg/kg bw * 1 / 0.38 m3/kg bw * 0.5 * (6.7 m3 / 10m3)
= 198 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Starting point for the DNEL calculation is a NOAEL. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov. 2012).
- AF for differences in duration of exposure:
- 4
- Justification:
- A assessment factor 2 is suggested by the ECHA TGD for exposure duration from subchronic (90 day) to chronic (see section R.8.4.3.1, Table R. 8-5) (ECHA, Nov 2012). As the exposure duration of females was 54 days an assessment factor of 4 is used.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- For an inhalation study already scaled according to the allometric principle, Chapter R 8.4.3.1 of ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- default assessment factor for remaining interspecies differences in case for systemic effects, Chapter R 8.4.3.1 of ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- default assessment factor for workers, Chapter 8.4.3.1 of ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor for good quality of the database, Chapter 8.4.3.1 of ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors are considered necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.96 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
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:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.125 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 225 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 225 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Converting the oral NOAEL rat into a dermal NOAEL is necessary to derive the correct starting point for the dermal route for which no long term study was carried out.
As a worst case consideration dermal absorption is considered as 100%.
- AF for dose response relationship:
- 1
- Justification:
- Starting point for the DNEL calculation is a NOAEL. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov 2012).
- AF for differences in duration of exposure:
- 4
- Justification:
- A assessment factor 2 is suggested by the ECHA TGD for exposure duration from subchronic (90 day) to chronic (see section R.8.4.3.1, Table R. 8-5) (ECHA, Nov 2012). As the exposure duration of females was 54 days an assessment factor of 4 is used.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An allometric scaling factor of 4 is suggested by the ECHA TGD (see section 8.4.3.1 of TGD; ECHA, Nov 2012) for interspecies differences.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 is suggested by the ECHA TGD (ECHA, Nov. 2012) for remaining interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- For intraspecies variability, the default assessment factor for worker for systemic effects is 5 (ECHA, Nov 2012).
- AF for the quality of the whole database:
- 1
- Justification:
- Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R.4.3.1 of TGD (ECHA, Nov 2012).
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors are considered to be necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- 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:
- 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:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.56 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):
- 400
- Dose descriptor starting point:
- NOAEL
- Value:
- 225 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 225 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Starting point for the DNEL calculation is a NOAEL. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov 2012).
- AF for differences in duration of exposure:
- 4
- Justification:
- A assessment factor 2 is suggested by the ECHA TGD for exposure duration from subchronic (90 day) to chronic (see section R.8.4.3.1, Table R. 8-5) (ECHA, Nov 2012). As the exposure duration of females was 54 days an assessment factor of 4 is used.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An allometric scaling factor of 4 is suggested by the ECHA TGD (see section 8.4.3.1 of TGD; ECHA, Nov 2012) for interspecies differences.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 is suggested by the ECHA TGD (ECHA, Nov. 2012) for remaining interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- For intraspecies variability, the default assessment factor for general population is 10 (ECHA, Nov. 2012).
- AF for the quality of the whole database:
- 1
- Justification:
- Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov. 2012).
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors are considered necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.56 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
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