Registration Dossier
Registration Dossier
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EC number: 454-190-9 | CAS number: 324763-51-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 59 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Acute exposure
The guidance on dose/concentration response regarding human health (section R8.1.2.5 of chapter R.8 of the Guidance on Information Requirements and Chemical Safety Assessment) indicates that acute DNELs do not need to be calculated for substances that are not classified for an acute toxicity hazard. As this substance is not classified for acute systemic toxicity, no acute systemic DNELs need to be calculated.
The substance is corrosive for the eyes. The available data do not allow a quantitative approach. According to the REACH guidance on information requirements and chemical safety assessment, Part E: Risk Characterisation, a qualitative risk characterisation should be performed for this endpoint. In order to guarantee ‘adequately control of risks’, it is necessary to stipulate risk management measures that prevent eye corrosion.
Long-term exposure
- Inhalation DNEL
For deriving the inhalation DNEL regarding long-term exposure the oral 28-day study was used as starting point. No adverse effects were observed in the oral 28-day toxicity study up to the highest tested dose of 1000 mg/kg bw/day. Therefore, a DNEL is actually not quantifiable. In case 1000 mg/kg bw/day is considered the NOAEL, the following DNEL is calculated:
Correction of starting point from an oral study to the inhalation route:
1000 mg/kg bw/day * 6.7m3/10m3 (correction for activity driven differences of respiratory volumes in workers compared to workers in rest) / 0.38 m3/kg bw (respiratory volume of rats for 8 hours exposure) / 1 (factor for route-to-route extrapolation) = 1763 mg/m3
The corrected starting point for inhalation is 1763 mg/m3.
The following assessment factors were used:
remaining differences: 1
intraspecies: 5
exposure duration: 6
quality of whole database: 1
Thus, the overall assessment factor is 30 and the DNEL for long-term exposure inhalation for workers: 59 mg/m3.
- Dermal DNEL
For deriving the dermal DNEL regarding long-term exposure the same starting point as used for derivation of the inhalation DNEL was used. No adverse effects were observed in the oral 28-day toxicity study up to the highest tested dose of 1000 mg/kg bw/day. Therefore, a DNEL is actually not quantifiable. In case 1000 mg/kg bw/day is considered the NOAEL, the following DNEL is calculated:
Correction of starting point from an oral study to the dermal route:
1000 mg/kg bw/day x 1 (factor for route-to-route extrapolation) = 1000 mg/kg bw/day
The corrected starting point for the dermal route is 1000 mg/kg bw/day.
The following assessment factors were used:
interspecies: 4
remaining differences: 1
intraspecies: 5
exposure duration: 6
quality of whole database: 1
Thus, the overall assessment factor is 120 and the DNEL for long-term exposure dermal for workers: 8 mg/kg bw/day.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 60
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 240
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 240
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Acute exposure
The guidance on dose/concentration response regarding human health (section R8.1.2.5 of chapter R.8 of the Guidance on Information Requirements and Chemical Safety Assessment) indicates that acute DNELs do not need to be calculated for substances that are not classified for an acute toxicity hazard. As this substance is not classified for acute systemic toxicity, no acute systemic DNELs need to be calculated.
The substance is corrosive for the eyes. The available data do not allow a quantitative approach. According to the REACH guidance on information requirements and chemical safety assessment, Part E: Risk Characterisation, a qualitative risk characterisation should be performed for this endpoint. In order to guarantee ‘adequately control of risks’, it is necessary to stipulate risk management measures that prevent eye corrosion.
Long-term exposure
- Inhalation DNEL
For deriving the inhalation DNEL regarding long-term exposure the oral 28-day study was used as starting point. No adverse effects were observed in the oral 28-day toxicity study up to the highest tested dose of 1000 mg/kg bw/day. Therefore, a DNEL is actually not quantifiable. In case 1000 mg/kg bw/day is considered the NOAEL, the following DNEL is calculated:
Correction of starting point from an oral study to the inhalation route:
1000 mg/kg bw/day / 1.15 m3/kg bw (respiratory volume of rats for 24 hours exposure) / 1 (factor for route-to-route extrapolation) = 870 mg/m3
The corrected starting point for inhalation is 870 mg/m3.
The following assessment factors were used:
remaining differences: 1
intraspecies: 10
exposure duration: 6
quality of whole database: 1
Thus, the overall assessment factor is 60 and the DNEL for long-term exposure inhalation for the general population: 14 mg/m3.
- Dermal DNEL
For deriving the dermal DNEL regarding long-term exposure the same starting point as used for derivation of the inhalation DNEL was used. No adverse effects were observed in the oral 28-day toxicity study up to the highest tested dose of 1304 mg/kg bw/day. Therefore, a DNEL is actually not quantifiable. In case 1304 mg/kg bw/day is considered the NOAEL, the following DNEL is calculated:
Correction of starting point from an oral study to the dermal route:
1000 mg/kg bw/day x 1 (factor for route-to-route extrapolation) = 1000 mg/kg bw/day
The corrected starting point for the dermal route is 1000 mg/kg bw/day.
The following assessment factors were used:
interspecies: 4
remaining differences: 1
intraspecies: 10
exposure duration: 6
quality of whole database: 1
Thus, the overall assessment factor is 240 and the DNEL for long-term exposure dermal for the general population: 4 mg/kg bw/day.
- Oral DNEL
For deriving the oral DNEL regarding long-term exposure the oral NOAEL of 1000 mg/kg bw/day from the 28-day toxicity study was used as starting point. No adverse effects were observed in the oral 28-day toxicity study up to the highest tested dose of 1000 mg/kg bw/day. Therefore, a DNEL is actually not quantifiable. In case 1000 mg/kg bw/day is considered the NOAEL, the following DNEL is calculated:
The following assessment factors were used:
interspecies: 4
remaining differences: 1
intraspecies: 10
exposure duration: 6
quality of whole database: 1
Thus, the overall assessment factor is 240 and the DNEL for long-term exposure dermal for the general population: 4 mg/kg bw/day.
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