Registration Dossier
Registration Dossier
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EC number: 700-762-0 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Hexadecene was not acutely toxic when administered via oral or dermal routes in animal studies. Although no acute inhalation studies were identified for hexadecene or any other single carbon number isomerised olefin, acute inhalation studies with structurally similar linear alpha olefins and multiple carbon number isomerised olefin substances (hex-1-ene, hexadec-1-ene, and alkenes, C10/11/12/13) did not report acute adverse effects; hence it can be inferred that hexadecene is not acutely toxic via inhalation. Therefore, hexadecene does not meet the classification and labelling criteria for an acute oral, dermal, or inhalation toxicant 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. There are no viscosity data available for hexadecene. However, read-across viscosity data was available for octadecene, a single carbon number isomerised olefin. The reported kinematic viscosity for octadecene was 3.44 mm2/sec at 40°C (Chilworth, 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 the read-across strategy used for isomerised olefins, it is inferred that hexadecene be classified and labelled as 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 developmental/reproductive screening study (Thorsrud, 2003) was available for single carbon number isomerised olefin, octadecene, which reported no treatment-related adverse effects on fertility or developmental parameters at the highest dose tested (1000 mg/kg bw/day). Results from developmental/reproductive screening studies conducted on other olefin substances such as alkenes, C6 (multiple carbon number isomerised olefin, Thorsrud, 2003), hex-1-ene (linear alpha olefin, Daniel, 1995 (a)), and tetradec-1-ene (linear alpha olefin, 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 extended one-generation reproductive toxicity study (OECD 443). 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.
A worker-DNELlong-term for dermal route-systemic and worker-DNELlong term for inhalation route-systemic were not derived for single or 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, Dunsteret al., 2008, and Brooker, 1999) and in a read-across 90-day repeated inhalation dose study with linear alpha olefin, hex-1-ene (Bennicket al., 1984). These results indicate that single carbon number and multiple carbon number isomerised olefins, 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 single or multiple carbon number isomerised olefins because oral exposure to these substances was not relevant exposure route for a worker population.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
General population DNELs for acute effects were not derived because no relevant hazard was apparent from the available toxicological data.
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 single or 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, Dunsteret 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 single carbon number and multiple carbon number isomerised olefins, 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.)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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