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

Poly alpha olefins and their respective structural analogues were not acutely toxic when administered via oral or dermal routes in several animal studies. Hence, these substances do not meet the classification and labelling criteria for acute oral or dermal toxicants as defined by EU DSD/DPD 67/548/EEC or CLP EU Regulation 1272/2008 (GHS aligned) criteria; therefore DNELs were not derived for these endpoints.

 

The available acute inhalation toxicity data indicate that some poly alpha olefins (viscosity <15 cSt at 40 ° C, average carbon number <C-30) are acutely toxic in experimental animal studies with inhalation LC50 values consistent with EU labelling requirements for Xn/R20 (Directive 67/548 EEC) or Acute Tox. 4, H332 (Regulation 1272/2008); a DNEL is required for substances meeting these physico-chemical criteria or where experimental data indicate a LC50 below 5 mg/L. However test data available for other samples with kinematic viscosity >15 cSt at 40 °C and an average C-number of 30 or higher return LC50 values in excess of 5 mg/L; no classification or DNEL is required for these substances.

 

Based on the reported kinematic viscosity and carbon number for 1-tetradecene, polymer with 1-dodecene, distn. residues, C36 -84 fraction (consisting of 50 wt% or more of the species of the same M. Wt.) (39.57 cSt, C-36 -84), this substance is not considered an acute inhalation hazard; therefore acute inhalation DNELs are not required.

 

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. The reported kinematic viscosity value for 1-tetradecene, polymer with 1-dodecene, distn. residues, hydrogenated, C36 -84 fraction (consisting of 50 wt% or more of species of same M Wt) at 40°C is 39.57 cSt (INEOS, 2010). This value exceeds the discriminating thresholds for classification for aspiration toxicity under EU Dangerous Substance Directive 67/548/EEC (< 7 cSt) and under CLP Regulation 1272/2008 (GHS aligned) (< 20.5 cSt). Therefore, 1-tetradecene, polymer with 1-dodecene, distn. residues, hydrogenated, C36 -84 fraction (consisting of 50 wt% or more of species of same M Wt) is not classified for aspiration toxicity. A DNEL is neither feasible nor appropriate for this endpoint.

 

A one-generation reproductive toxicity study in which Alkane 4 (a structural analogue to 1-decene trimer, hydrogenated and tetramers) was administered via oral gavage to rats showed no adverse effects on fertility or development at the highest dose tested of 1000 mg/kg bw/day (Knox et al., 2007). Additionally, rats exposed to Ethylflo 166 (1-decene homopolymer hydrogenated) in utero were again treated with Ethyflo 166 for an additional 91 days beginning 22 days after birth (Daniel, 1994). There were no treatment-related effects reported at the highest dose tested (1000 mg/kg bw/day) in the parental generation, offspring at birth, or following 91 days of subsequent oral exposure. The weight of evidence presented by these studies suggests that poly alpha olefins, as a group, are unlikely to present a significant hazard potential to fertility and development; therefore no DNEL for reproductive toxicity is necessary. 

 

Workers

 

A worker-DNELlong-term for dermal route-systemicand worker-DNELlong term for inhalation route-systemicwere not derived for poly alpha olefins because no adverse findings relevant to human health risk assessment were found in several, good quality, high reliability repeated dose studies with these substances at doses at or exceeding a limit dose of 1000 mg/kg bw/day (Daniel, 1994, Cooper, 1995, and Knox et al., 2007). These results indicate that poly alpha olefins, as a class, possess an inherently low hazard potential with regard to human health. Therefore, derivation of DNELs is unnecessary. A worker-DNELlong-term for oral route-systemic was not calculated for poly alpha olefins because oral exposure to these substances was not considered a relevant route of exposure for a worker population in a workplace setting.

 

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 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-systemicwere not derived for poly alpha olefins because no adverse findings relevant to human health risk assessment were found in several, good quality, high reliability repeat dose studies with these substances at doses at or exceeding a limit dose of 1000 mg/kg bw/d (Daniel, 1994, Cooper, 1995, and Knox et al., 2007). These results indicate that poly alpha olefins, as a class, possess an inherently low hazard potential with regard to human health. Therefore, derivation of DNELs is unnecessary.