Registration Dossier
Registration Dossier
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EC number: 931-746-3 | CAS number: -
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
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Isomerised olefins; alpha, internal, linear and branched – multiple carbon numbers were not acutely toxic when administered via oral, dermal, or inhalation routes in several animal studies. Hence, these substances do not meet the classification and labelling criteria for acute oral, dermal, or inhalation toxicants according to EU DSD/DPD 67/548/EEC or CLP EU Regulation 1272/2008 (GHS aligned) criteria; therefore short-term DNELs were not derived for these endpoints.
The reported kinematic viscosity value measured for alkenes, C20-24 at 40 degrees Celsius was 5.466 mm2/sec (Intertek, 2010). This value meets the criteria for classification and labelling (< 7 or < 20.5 mm2/sec, respectively) for aspiration toxicity according to EU DSD/DPD 67/548/EEC and CLP Regulation 1272/2008 (GHS aligned). Therefore, alkenes, C20-24 classified and labelled as Xn; R65: harmful, may cause lung damage if swallowed according to EU DSD/DPD 67/548/EEC and as Category 1 for aspiration toxicity; H304: May be fatal if swallowed and enters airway according to EU CLP Regulation 1272/2008 (GHS aligned). A DNEL is neither feasible nor appropriate for this endpoint.
One repeated dose/developmental/reproductive screening study in rats, available for alkenes, C6 (Thorsrud, 2003) reported no adverse effects on fertility or developmental parameters at the highest dose tested (1000 mg/kg). Results from developmental/reproductive screening studies conducted on other olefin substances such as octadecene (single carbon number isomerised olefin, Thorsrud, 2003), hex-1-ene (linear alpha olefins, Daniel, 1995 (a)), and tetradec-1-ene (linear alpha olefins, Daniel, 1995 (b)) were also negative for effects on fertility and development. The weight of evidence presented by these studies suggests that higher olefin substances, as a group, are unlikely to present a significant hazard potential to fertility and development. However, these studies do not meet standard REACH information requirements for this endpoint since the studies do not fully assess all phases of the reproductive cycle (e.g. oestrus cyclicity, sperm quality, post weaning development, maturation and the reproductive capacity of the offspring). Therefore, these studies cannot be substituted for a full teratogenicity study (OECD 414) or two-generation study (OECD 416). Further testing of oct-1-ene and C20-C22 (even numbered, linear and branched) and C24 (branched) alkenes is therefore proposed to address these data gaps. In the interim, formal development of worker and general population DNELs for fertility/developmental endpoints will be deferred for all linear alpha olefins, including (alkenes, C20-24), and “DNEL not quantifiable” will be included in the IUCLID dossier and the CSR, supported by a suitable justification.
Workers
A worker-DNELlong-term for dermal route-systemic and worker-DNELlong term for inhalation route-systemic were not derived for multiple carbon number isomerised olefins because no adverse findings relevant to human health risk assessment were found in good quality, high reliability repeated oral dose studies with alkenes, C6, alkenes, C16-18, and two studies with alkenes, C20-C24 at limit doses of 1000 mg/kg bw/day (Thorsrud, 1993; Clubb, 2000, Dunster et al., 2008, and Brooker, 1999) and in a read-across 90-day repeated inhalation dose study with linear alpha olefin, hex-1-ene (Bennick et al., 1984). These results indicate that isomerised olefins with a range of carbon numbers, as a class, possess an inherently low hazard potential with regard to human health. Therefore, derivation of long-term DNELs is unnecessary. However, as noted elsewhere in this dossier, it is considered prudent to propose additional sub-chronic testing via the oral route onoct-1-ene and C20-C22 (even numbered, linear and branched) and C24 (branched) alkenesin order to extend the amount of information available. The position regarding the need (or otherwise) for long-term DNELs will be updated once this additional information is available. In the interim, the phrase “DNEL not quantifiable” along with a brief supporting justification is included in the IUCLID dossier. A worker-DNELlong-term for oral route-systemicwas not calculated for linear alpha olefins because oral exposure to these substances was not relevant for a worker population.
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
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
General Population
General population DNELs for acute effects were not derived because such effects were not considered relevant for general population exposures to isomerised olefins with a range of carbon numbers. A general population-DNELlong-term for oral route-systemic, general population-DNELlong-term for dermal route-systemic, and general population-DNELlong term for inhalation route-systemic were not derived for multiple carbon number isomerised olefins because no adverse findings relevant to human health risk assessment were found in good quality, high reliability repeated oral dose studies with alkenes, C6, alkenes,C16-18, and two studies with alkenes, C20-C24 at limit doses of 1000 mg/kg bw/day (Thorsrud, 1993; Clubb, 2000, Dunster et al., 2008, and Brooker, 1999) and in a read-across 90-day repeated inhalation dose study with linear alpha olefin, hex-1-ene (Bennick et al., 1984). These results indicate that isomerised olefins with a range of carbon numbers, as a class, possess an inherently low hazard potential with regard to human health. Therefore, derivation of long-term DNELs is unnecessary.
(See discussion under Workers for further details.)
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