Registration Dossier
Registration Dossier
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EC number: 441-100-8 | CAS number: 351197-46-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.53 mg/m³
DNEL related information
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 300
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Additional information - workers
Calculation of DNELs is based on the subacute oral 28d NOAEL (rat) of 150 mg/kg bw/day according to the "Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health", ECHA, May 2008.
Short term DNELs:
Calculation of short term DNELs would result in higher values as for the long term exposure as the starting point for systemic effects would be the dose level of the acute study where no effects occured. This is with >2000 mg/kg bw for dermal exposure (Arcelin, 2002a) higher than the 28 day value of 150 mg/kg bw/day. Additionally inhalation exposure is very unlikely (see below). Therefore the acute risks are sufficiently covered by the derivation of long term DNELs.
Long-term inhalation DNEL worker:
The NAEC can be determined by calculating from oral exposure to 8 -hour inhalation exposure by factor 0.38 and allometric scaling from rat to human worker by factor 0.67. Using the default assessment factors (Intraspecies 5, remaining differences 2.5, exposure duration 6 = 75) a DNEL of 3.53 mg/m³ would result.
However, the liquid substance has a low vapour pressure (< 0.01 Pa at 25 °C) and exposure of workers is very unlikely, as spray application is not given for the test substance. The saturated vapour concentration of UAX-1179 was calculated to be 0.276 mg/m³ and therefore much lower than the DNEL value derived from route-to-route extrapolation.
The endpoints for which the available data may trigger a qualitative risk characterization include eye irritation (R41, Category 1) and skin sensitisation (R43, Category 1). However, DNELs for local effects were not given, as the implementation of risk management measures (RMMs) and operational conditions (OCs) by workers precludes exposure of skin and eyes.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.87 mg/m³
DNEL related information
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
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
DNEL related information
- Overall assessment factor (AF):
- 600
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- sensitisation (skin)
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
DNEL related information
- Overall assessment factor (AF):
- 600
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Calculation of DNELs is based on the subacute oral 28d NOAEL (rat) of 150 mg/kg bw/day according to the "Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health", ECHA, May 2008.
Short term DNELs:
Calculation of short term DNELs would result in higher values as for the long term exposure. Therefore the acute risks are sufficiently covered by the derivation of long term DNELs.
Long-term inhalation DNEL general population:
The NAEC can be determined by calculating from oral exposure to 8 -hour inhalation and allometric scaling from rat to human worker by factor 1.15. Using the default assessment factors (Intraspecies 10, remaining differences 2.5, exposure duration 6 = 150) a DNEL of 0.87 mg/m³ would result.
However, the liquid substance has a low vapour pressure (< 0.01 Pa at 25 °C) and a formation of aerosols can be excluded. Thus, the exposure of general population is very unlikely. The saturated vapour concentration of UAX-1179 was calculated to be 0.276 mg/m³ and therefore much lower than the DNEL value derived from route-to-route extrapolation.
Consumers are typically exposed to a diluted preparation of the substance with a concentration of 0.2 % (w/w) as flexible foam. According to REGULATION (EC) No 1272/2008 classification criteria for mixtures (section 3.3.3) this concentration triggers no classification neither for eye effects nor for skin sensitisation. Therefore local DNELs for general population were not given.
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