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EC number: 406-640-0 | CAS number: 136920-07-5 KEROFLUX ES 3241
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
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:
- 250 mg/kg bw/day
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
No systemic effects have been observed in rodent studies after short-term and long-term exposure to Keroflux ES 3241. The LD50 for acute oral and acute dermal exposure is >2000 mg/kg bw and based on the physical chemical properties and the use of Keroflux ES 3241 an inhalation exposure is unlikely. Thus, derivation of a DNEL for acute / short-term exposure is not appropriate according to Chapter R8 of the ECHA guidance on information requirements and chemical safety assessment (2008).
Keroflux ES 3241 has been tested postive for skin sensitization in a guinea-pig maximization test. Because of the single induction dose regime employed the maximization test does not allow to derive a starting point for DNEL derivation. Based on the potency considerations in chapter R8 of the ECHA guidance on information requirements and chemical safety assessment (2008) Keroflux ES 3241 can be considered rather a moderate skin sensitizer by taking into account the concentration for intradermal induction (> 1%) as well as the incidence of sensitization (> 60%). Since the data availabe do not allow for a DNEL derivation the operational conditions and risk management measures are installed to ensure that the exposure to Keroflux ES 3241 is as low as possible.
DNEL - systemic effects for long-term exposure can be derived starting with the NOAEL from the one-generation study (1000 mg/kg bw/d). Since no information on the dermal absorption of Keroflux ES 3241 is available worst-case assumption of 100% penetration is made for oral to dermal extrapolation. No adverse effects have been observed with regard to systemic toxicity, reproductive toxicity and developmental toxicity. Thus, default factors for allometric scaling, intraspecies variation and time extrapolation are chosen:
allometric scaling: 4
intraspecies variation: 5
time extrapolation (subchronic to chronic): 2
The overall assessment factor of 40 applied to the NOAEL of 1000 mg/kg bw/d results in a DNEL (dermal) for worker of 250 mg/kg bw/d.
Derivation of a inhalation DNEL - systemic effects as well as local effects for long-term exposure is considered not appropriate because of the physicochemical properties and the use of Keroflux ES 3241.
Operational conditions and risk management measure installed to minimize risk after a single dermal exposure are considered sufficient to prevent for local effect after long-term exposure.
General Population - Hazard via inhalation route
Systemic effects
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:
- 125 mg/kg bw/day
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:
- 125 mg/kg bw/day
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
No systemic effects have been observed in rodent studies after short-term and long-term exposure to Keroflux ES 3241. The LD50 for acute oral and acute dermal exposure is >2000 mg/kg bw and based on the physical chemical properties and the use of Keroflux ES 3241 an inhalation exposure is unlikely. Thus, derivation of a DNEL for acute / short-term exposure for all three relevant routes of exposure is not appropriate according to Chapter R8 of the ECHA guidance on information requirements and chemical safety assessment (2008).
Keroflux ES 3241 has been tested postive for skin sensitization in a guinea-pig maximization test. Because of the single induction dose regime employed the maximization test does not allow to derive a starting point for DNEL derivation. Based on the potency considerations in chapter R8 of the ECHA guidance on information requirements and chemical safety assessment (2008) Keroflux ES 3241 can be considered rather a moderate skin sensitizer by taking into account the concentration for intradermal induction (> 1%) as well as the incidence of sensitization (> 60%). Data availabe do not allow for a DNEL derivation, however use and final concentration of Keroflux ES 3241 in fuel as well as risk managment measure installed already at the gas stations are considered sufficient to minimize risk for local effects after short-term exposure to Keroflux ES 3241.
DNEL - systemic effects for long-term exposure can be derived starting with the NOAEL from the one-generation study (1000 mg/kg bw/d). Since no information on the dermal absorption of Keroflux ES 3241 is available worst-case assumption of 100% penetration is made for oral to dermal extrapolation. No adverse effects have been observed with regard to systemic toxicity, reproductive toxicity and developmental toxicity. Thus, default factors for allometric scaling, intraspecies variation and time extrapolation are chosen:
allometric scaling: 4
intraspecies variation: 10
time extrapolation (subchronic to chronic): 2
The overall assessment factor of 80 applied to the NOAEL of 1000 mg/kg bw/d results in a DNEL (oral and dermal) for the general population of 125 mg/kg bw/d.
Derivation of a inhalation DNEL - systemic effects as well as local effects for long-term exposure is considered not appropriate because of the physicochemical properties and the use of Keroflux ES 3241.
Operational conditions and risk management measure installed to minimize risk after a single dermal exposure are considered sufficient to prevent for local effect after long-term exposure.
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