Registration Dossier
Registration Dossier
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EC number: 249-707-8 | CAS number: 29590-42-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 21 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):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 529 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The dose descriptor of 600 mg/kg-day (NOAEL) from the 90-day oral gavage study was used. This oral NOAEL was converted (via route-to-route extrapolation) to a corrected inhalation NOAEC using ECHA Guidance and assuming ECHA default absorption values of 50% via the oral route of exposure and 100% via the inhalation route of exposure. The following Assessment Factors (AFs) were applied to the corrected dose descriptor of 529 mg/m3 to calculate the DNEL: Interspecies (remaining differences = 2.5); Intraspecies (5); Exposure duration (2); Dose-response (1); and Quality of database (1). Total AF applied = 25.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- 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
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 57 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Route to route extrapolation not required.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 62.5 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor:
- other: LLNA EC3=25% for IOA was used as the dose descriptor. As per ECHA guidance (Chapter R.8; 2012), this EC3 was converted to a dose/area by multiplying by 250. The resulting value of 6250 µg/cm2 was then used as the dose descriptor for the IOA dermal DNEL.
- AF for other interspecies differences:
- 10
- AF for remaining uncertainties:
- 10
- Justification:
- Matrix effect
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Additional information - workers
The following human exposure patterns were evaluated and found to not be relevant. Therefore, the corresponding DNELs were not derived:
Dermal DN(M)EL for Acute/short-term exposure - systemic effects
Inhalation DN(M)EL for Acute/short-term exposure - systemic effects
Dermal DN(M)EL for Acute/short-term exposure - local effects
Inhalation DN(M)EL for Acute/short-term exposure - local effects
Inhalation DN(M)EL for Long-term exposure - local effects
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 261 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The dose descriptor of 600 mg/kg-day (NOAEL) from the 90-day oral gavage study was used. This oral NOAEL was converted (via route-to-route extrapolation) to a corrected inhalation NOAEC using ECHA Guidance and assuming ECHA default absorption values of 50% via the oral route of exposure and 100% via the inhalation route of exposure. The following Assessment Factors (AFs) were applied to the corrected dose descriptor of 261 mg/m3 to calculate the DNEL: Interspecies (remaining differences = 2.5); Intraspecies (10); Exposure duration (2); Dose-response (1); and Quality of database (1). Total AF applied = 50.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- 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
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 57 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Route to route extrapolation was not needed.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
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:
- 3 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Route to route extrapolation was not required.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- 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
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Additional information - General Population
The following human exposure patterns were evaluated and found to not be relevant. Therefore, the corresponding DNELs were not derived:
Dermal DN(M)EL for Acute/short-term exposure - systemic effects
Inhalation DN(M)EL for Acute/short-term exposure - systemic effects
Oral DN(M)EL for Acute/short-term exposure - systemic effects
Dermal DN(M)EL for Acute/short-term exposure - local effects
Inhalation DN(M)EL for Acute/short-term exposure - local effects
Dermal DN(M)EL for Long-term exposure - local effects
Inhalation DN(M)EL for Long-term exposure - local effects
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