Registration Dossier
Registration Dossier
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EC number: 421-880-6 | CAS number: 201792-73-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.47 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- NOAEL
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
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:
- 0.7 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The long-term DNEL is based on a NOAEL of 150 mg/kg based on 42 repeated dose toxicity.
Long-term DNEL for dermal route calculation (systemic effects, route to-route extrapolation) = 150 *1 (a) / 4*2.5*5 (b) *6 (c)* 1,4(d) = 0.7 mg/kg bw/day
(a) route to route extrapolation oral to dermal
(b) assessment factors (interspecies * intraspecies (4*2.5) * 5)
(c) Correction for duration from subacute to chronic (6)
(d) correction factor between human workers and experimental exposure condition
Long-term DNEL for the inhalation route (systemic effects, route to-route extrapolation) = 150 * (1/ sRV(a)) * 0.67 (b) /75 (c)*1.4 (d) *0.5 (e ) = 2.47 mg/m3
(a) Standard respiratory volume (sRV) rat: 0.38 m3/kg
(b) Correction for worker respiratory volume (conservative default for route to route)
(c)interspecies (without allometric scaling) * intraspecies * correction for duration: (2.5 * 5 * 6 )
(d) Correction for differences between human and experimental exposure conditions (1.4)
(e) Corrction for bioavailability (0.5)
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.435 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 150
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The long-term DNEL is based on a NOAEL for repeated dose toxixity of 150 mg/kg.
Long-term DNEL for dermal route calculation (systemic effects, route to-route extrapolation) = 150 *1 (a) / 4*2.5*10 (b) *6 (c) = 0.25 mg/kg bw/day
(a) route to route extrapolation oral to dermal
(b) assessment factors (interspecies * intraspecies (4*2.5) * 10)
(c) Correction for duration from subacute to chronic (6)
Long-term DNEL for the inhalation route (systemic effects, route to-route extrapolation) = 150 * (1/ sRV(a)* 0.5 (b) 150 (c)) = 0.435 mg/m3
(a) Standard respiratory volume (sRV) rat 24 h: 1.15 m3/kg
(b) Corrction for bioavailability (0.5)
(c)interspecies (without allometric scaling) * intraspecies * correction for duration: (2.5 * 10 * 6 )
Long-term DNEL for oral route calculation (systemic effects, route to-route extrapolation) = 150 / 4*2.5*10 (b) *6 (c) = 0.25 mg/kg bw/day
(b) assessment factors (interspecies * intraspecies (4*2.5) * 10)
(c) Correction for duration from subacute to chronic (6)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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