Registration Dossier
Registration Dossier
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EC number: 251-073-2 | CAS number: 32509-66-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.94 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 88.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Long-term inhalatory DNEL(developmental) based on NOAEL (OECD 414, oral) in rats:
- NOAEC(inhalation) derived according to “Guidance on information requirements and chemical safety assessment”, Chapter R.8.4.2, Figure R. 8-3 (p. 21).
corrected NOAEC(inhalation)= NOAEL(oral, rat) x 1/sRVratxABS(oral-rat)/ABS(inh-human) x sRVhuman/wRV
= 100 mg/kg x 1/0.38 m3/kg/d x 50%/100% x 6.7 m3/10 m3
= 88.2 mg/m3
with sRV: standard respiratory volume; ABS: Absorption; wRV: worker respiratory volume
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is the starting point for DNEL derivation. According to Guidance on information Chapter R.8, p. 30, the assessment factor is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- relevant NOAEL is derived from a developmental toxicity study (14 days dosing)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- interspecies difference is included in the calculation by correcting the respiratory volumes of rat and man (for details refer to "explanation for the modification of the dose descriptor starting point")
- AF for other interspecies differences:
- 1
- Justification:
- It can be assumed that workers are trained in handling chemicals and according to general occupational health regulations an exposure of pregnant workers to the substance at the production site is excluded. However, for precautionary reasons the DNEL is based on the NOAEL derived on develpomental effects exclusively. This situation is very unlikely to occur in the occupational environment. Therefore, the assessment factor 1 is considered to be sufficient.
- AF for intraspecies differences:
- 5
- Justification:
- according to Guidance on information Chapter R.8, Table 8-6, p. 32
- AF for the quality of the whole database:
- 1
- Justification:
- Original study is reliable without restriction
- AF for remaining uncertainties:
- 1
- Justification:
- no further uncertainties assumed
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.83 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Workers:Long-term dermal systemic DNEL(developmental) based on NOAEL (OECD 414, oral) in rats:
- NOAEL(dermal) derived according to “Guidance on information requirements and chemical safety assessment”, Appendix R. 8-2, Example B.5 (p. 63).
corrected NOAEL(dermal)= NOAEL(oral, rat) x Absorption(oral-rat)/Absorption(dermal-human)
= 100 mg/kg bw x 100%/100%
= 100 mg/kg bw
- AF for dose response relationship:
- 1
- Justification:
- The orginal study is reliable without restrictions. The route to route extrapolation was performed by applying the equation as cited in Guidance on information requirements and chemical safety assessment, Chapter R.8 (by ECHA) with all recommended assessment factors.
- AF for differences in duration of exposure:
- 6
- Justification:
- relevant NOAEL is derived from a developmental toxicity study (14 days dosing)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- according to Guidance on information Chapter R.8, Table 8-3, p. 24
- AF for other interspecies differences:
- 1
- Justification:
- It can be assumed that workers are trained in handling chemicals and according to general occupational health regulations an exposure of pregnant workers to the substance at the production site is excluded. However, for precautionary reasons the DNEL is based on the NOAEL derived on develpomental effects exclusively. This situation is very unlikely to occur in the occupational environment. Therefore, the assessment factor 1 is considered to be sufficient.
- AF for intraspecies differences:
- 5
- Justification:
- according to Guidance on information Chapter R.8, Table 8-6, p. 32
- AF for the quality of the whole database:
- 1
- Justification:
- Original study is reliable without restriction
- AF for remaining uncertainties:
- 1
- Justification:
- no further uncertainties assumed
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:
- 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:
- 0.29 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 43.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Long-term inhalatory DNEL(developmental) based on NOAEL (OECD 414, oral) in rats:
- NOAEC(inhalation) derived according to “Guidance on information requirements and chemical safety assessment”, Chapter R.8.4.2, Figure R. 8-3 (p. 21).
corrected NOAEC(inhalation)= NOAEL(oral, rat) x 1/sRVratxABS(oral-rat)/ABS(inh-human)
= 100 mg/kg x 1/1.15 m3/kg/d x 50%/100%
= 43.5 mg/m3
with sRV: standard respiratory volume; ABS: Absorption; wRV: worker respiratory volume
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is the starting point for DNEL derivation. According to Guidance on information Chapter R.8, p. 30, the assessment factor is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- relevant NOAEL is derived from a developmental toxicity study (14 days dosing)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- according to Guidance on information Chapter R.8, Table 8-3, p. 24
- AF for other interspecies differences:
- 10
- Justification:
- according to Guidance on information Chapter R.8, Table 8-6, p. 32
- AF for intraspecies differences:
- 2.5
- Justification:
- according to Guidance on information Chapter R.8, Table 8-6, p. 32
- AF for the quality of the whole database:
- 1
- Justification:
- Original study is reliable without restriction
- AF for remaining uncertainties:
- 1
- Justification:
- no further uncertainties assumed
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.17 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Long-term dermal systemic DNEL(developmental) based on NOAEL (OECD 414, oral) in rats:
- NOAEL(dermal) derived according to “Guidance on information requirements and chemical safety assessment Appendix R. 8-2, Example B.5 (p. 63).
corrected NOAEL(dermal)= NOAEL(oral, rat) x Absorption(oral-rat)/Absorption(dermal-human)
= 100 mg/kg bw x 100%/100%
= 100 mg/kg bw
- AF for dose response relationship:
- 1
- Justification:
- The orginal study is reliable without restrictions. The route to route extrapolation was performed by applying the equation as cited in Guidance on information requirements and chemical safety assessment, Chapter R.8 (by ECHA) with all recommended assessment factors.
- AF for differences in duration of exposure:
- 6
- Justification:
- relevant NOAEL is derived from a developmental toxicity study (14 days dosing)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- according to Guidance on information Chapter R.8, Table 8-3, p. 24
- AF for other interspecies differences:
- 2.5
- Justification:
- according to Guidance on information Chapter R.8, Table 8-6, p. 32
- AF for intraspecies differences:
- 10
- Justification:
- according to Guidance on information Chapter R.8, Table 8-6, p. 32
- AF for the quality of the whole database:
- 1
- Justification:
- Original study is reliable without restriction
- AF for remaining uncertainties:
- 1
- Justification:
- no further uncertainties assumed
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:
- 0.17 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
n.a., relevant study was performed using the oral route
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is the starting point for DNEL derivation. According to Guidance on information Chapter R.8, p. 30, the assessment factor is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- relevant NOAEL is derived from a developmental toxicity study (14 days dosing)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- according to Guidance on information Chapter R.8, Table 8-3, p. 24
- AF for other interspecies differences:
- 2.5
- Justification:
- according to Guidance on information Chapter R.8, Table 8-6, p. 32
- AF for intraspecies differences:
- 10
- Justification:
- according to Guidance on information Chapter R.8, Table 8-6, p. 32
- AF for the quality of the whole database:
- 1
- Justification:
- Original study is reliable without restriction
- AF for remaining uncertainties:
- 1
- Justification:
- no further uncertainties assumed
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
none
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