Registration Dossier

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. 

Regulatory classification and labeling for aspiration toxicity relies on the measured or calculated kinematic viscosity of a substance at 40°C rather than results from toxicological studies with animals. Kinematic viscosity is defined as dynamic viscosity (expressed in mPa s) /density (expressed in g/cm3). There are no viscosity data available for alkenes, C11/C13/C14; therefore read across was made to octadecene, an isomerised olefin; alpha, internal, linear and branched – single carbon number.The reported kinematic viscosity for octadecene was 3.44 mm2/sec at 40°C (Chilworth Technology LTD, 2010). The discriminating thresholds for classification for aspiration toxicity are 7 mm2/sec and 20.5 mm2/sec for EU DSD/DPD 67/548/EEC and CLP EU Regulation 1272/2008 (GHS aligned), respectively. Based on its reported viscosity, octadecene is classified as an aspiration toxicant. Based on the read across strategy used for isomerised olefins, alkenes, C11/C13/C14 is therefore also classified and labelled for aspiration toxicity as follows: R65: Harmful, may cause lung damage if swallowed according to EU DSD/DPD 67/548/EEC and Category 1; 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 (isomerised olefins; alpha, internal, linear and branched - single carbon number, 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 on oct-1-ene (CAS RN 111-66 -0), a linear alpha olefin, has been proposed to address these outstanding toxicological endpoint data gaps for all higher olefins. In the interim, formal development of worker and general population DNELs for fertility/developmental endpoints will be deferred for all multiple carbon number isomerised olefins, including alkenes, C11/C13/C14.

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. A worker-DNELlong-term for oral route-systemicwas not calculated for multiple carbon number isomerised olefins because oral exposure to these substances was not considered a relevant route of exposure 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 Poplulation

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-systemicwere 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.