Registration Dossier
Registration Dossier
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EC number: 213-701-3 | CAS number: 1003-14-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.2 mg/m³
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: see discussion (OEL of 2 ppm)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.2 mg/m³
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- DNEL derivation method:
- other: see discussion (OEL of 2 ppm)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic 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
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Justification for read-across to propylene oxide:
A study determining the effect of n-Pentenoxide-1,2 following repeated inhalation is not available. However, a read-across to propylene oxide (CAS: 75-56-9), another member of the epoxide family, can be made, for which a OEL (occupational exposure level) value exists(see below). The same threshold level is also established for Butenoxide-1,2. The only structural difference between n-Pentenoxid-1,2 and propylene oxide is the presence of two additional CH2-groups in n-Pentenoxide-1,2. The chemical characteristics between these two substances are quite similar, with propylene oxide being more soluble in water (425 g/L vs. 23 g/L water solubility) and less lipophilic (log Pow=0.055 vs. 1.29) and exhibiting a higher vapor pressure (740 hPa vs 70 hPa) as compared with n-Pentenoxide-1,2. It has been shown that the toxicities of epoxides decrease from ethylene oxide to propylene oxide to 1,2-Butenoxide, suggesting that the toxicity of this reactive group of epoxide chemicals decreases with increasing length of the carbon backbone (Fox et al, 1983; NTP report No 267, 1985). In line with this assumption, the oral LD50 and inhalation LC50 of propylene oxide is smaller (382 mg/kg and 9.95 mg/L, respectively) as compared with n-Pentenoxide-1,2 (1460 mg/kg and > 10.6 < 21.3 mg/, respectively), further supporting the validity of a read-across from n-Pentenoxide-1,2 to propylene oxide, taking into account that this will represent a worst case scenario.
DNEL for workers, long-term inhalation (local effects are critical):
The primary aspect to be considered in deriving safe long-term exposure levels for propylene oxide is its local carcinogenicity with the nasal epithelium as primary target, which is well established experimentally in rats and mice. There are no reports of carcinogenicity of propylene oxide from studies in humans.
A number of worker exposure levels are published for propylene oxide. In Europe, published country OEL (occupational exposure level) values range from 1-50 mg/m3 (0.4-20 ppm) with the majority of values set at 4.8 mg/m3 (2 ppm). The American Conference of Governmental Industrial Hygienists (ACGIH) also has set a TLV of 2 ppm for propylene oxide based on local respiratory tract findings (ACGIH, 2001). The toxicity database available for propylene oxide demonstrates that worker exposure levels of about 2 ppm are adequately protective for respiratory effects. Sweeney et al. (2009) performed dose-response assessments of the rodent toxicity studies and concluded point of departure values for nasal tumors of 53 ppm (128 mg/m3) for mice and 66 ppm (159 mg/m3) for rats, representing the LED10 (lowest calculated dose of the chemical that is expected to increase the cancer rate by 10%) for continuous lifetime exposures (24 hr/day; 7 day/week; 70 years). These values are well above present worker exposure levels of about 2 ppm (margins of exposure of 25-30), with additional margins of exposure of around 3-fold from translating a continuous lifetime exposure scenario back to a working lifetime exposure scenario, as recommended by ECETOC (2010).
Taken together, based on available OEL values and assessments of the propylene toxicity database, 4.8 mg/m3 (2 ppm) is proposed as the local long-term inhalation DNEL for workers. A separate systemic long-term inhalation DNEL was not derived as the local long-term DNEL was considered protective of systemic toxicity. Considering that the toxicity of n-Pentenoxide-1,2 is lower as compared with propylene oxide, using this threshold level as no-effect-level describes a worst-case scenario and will hence adequately cover a potential risk of n-Pentenoxide-1,2 for the workers' safety. Thus, the systemic long-term no-effect level of n-Pentenoxide-1,2 is 2 ppm or 7.2 mg/m3.
Worker DNEL Long term-inhalation, local effects – 7.2 mg/m3
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
No DNEL/DMEL is proposed for the general population, since the use of the substane is not foreseen in consumer products.
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