1-Dodecene, polymer with 1-decene, hydrogenated

Endpoint summary

Description of key information

Three read-across 28-day oral exposure studies (OECD 407) and three 90-day oral exposure studies (OECD 408/OECD 415) were identified either within category or from a structural analogue. There were no key dermal or inhalation repeated dose studies identified.
Overall, the 28-day exposure studies found no toxicity when the respective poly alpha olefins were administered orally. Results were as follows.
• The NOAEL is 6245 mg/kg/day in male rats and 6771 mg/kg/day in female rats for the 28-day oral repeated dose study from 1-decene, homopolymer, hydrogenated.
• The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1-dodecene dimer with 1-decene, hydrogenated.
• The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1 -dodecene, trimer.
For the 90-day oral exposure studies, results were as follows.
• The NOAEL is 4145.4 mg/kg bw in male rats and 4619.9 mg/kg bw in female rats for the 90-day exposure study from 1-decene, homopolymer, hydrogenated.
• The NOAEL is 1000 mg/kg bw in male and female rats for the 91-day exposure study from 1-decene, homopolymer, hydrogenated.
• The NOAEL is 1000 mg/kg bw in male and female rats for the 90-day one-generation reproduction study with subchronic toxicity from 1 -dodecene, trimer.

Additional information

There were no identified key studies for repeated oral, dermal, or inhalation exposure for dec-1-ene, dimers, hydrogenated. Read-across studies within poly alpha olefins were used to assess repeated dose toxicity through oral exposure. There were, however, no studies identified within category for repeated dose toxicity for either inhalation or dermal exposure.

 

Repeat Dose Oral Toxicity

 

Three 28-day studies and three 90-day repeated dose studies for oral exposure were identified. For the 28-day repeated dose studies, studies were identified from 1-decene, homopolymer, hydrogenated; 1-dodecene dimer with 1-decene, hydrogenated, and 1 -dodecene trimer, hydrogenated, a structural analog. For 90-day exposures, studies were identified from 1-decene, homopolymer, hydrogenated and 1 -dodecene, trimer All studies were considered robust and of good quality.

 

Overall, the 28-day exposure studies produced no mortalities or significant clinical or systemic toxicity when the respective poly alpha olefins were administered orally. For one of the 28-day repeated dose studies, 1-decene, homopolymer, hydrogenated, was administered to F-344 rats (5 sex/dose) in the diet for four weeks at nominal concentrations of 0, 8000; 20,000; or 50,000 ppm (equivalent overall mean daily intakes were 1039, 2538, or 6245 mg/kg/day for males and 995, 2481, or 6771 mg/kg/day for females) (Cooper, 1994). Dietary administration of 1 -decene, homopolymer, hydrogenated to male and female F-344 rats at levels up to 50,000 ppm for 4 weeks did not produce toxicologically significant effects. Therefore, the subacute oral NOAEL for 1 -decene, homopolymer, hydrogenated is 6245 mg/kg/day in males and 6771 mg/kg/day in females. In the second 28-day repeated dose study conducted with 1-dodecene dimer with 1-decene, hydrogenated was administered to 6 Sprague-Dawley rats/sex/dose at dose levels 0, 200, 500, or 1000 mg/kg bw/day for 29 days (Cooper, 1989). A recovery group (6 rats), dosed with 0 or 1000 mg/kg/day of the test substance, was observed for two weeks post-dosing. No mortality, compound-related systemic toxicity or pathological changes were observed in the study or recovery groups at the limit dose of 1000 mg/kg 1 -dodecene, dimer with 1 -decene. Statistically significant changes occurred in food consumption, haematology, serum chemistry, and organ weights; however, none of the changes were considered to be of toxicological significance. No LOAEL could be determined due to lack of any affects. The NOAEL was reported as 1000 mg/kg/day. Lastly, a short-term oral exposure study conducted with 1 -dodecene, trimer, a structural analogue for poly alpha olefins, found no compound-related effects in mortality, clinical signs, body weight, food consumption, haematology, clinical chemistry, organ weights, or gross and histologic pathology when 1 -dodecene, trimer was administered to 5 Sprague-Dawley CD rats/sex/dose at dose levels 0 or 1000 mg/kg bw/day for 28 consecutive days (Coles, 1995). The NOAEL was reported as 1000 mg/kg/day.

 

In a 90-day study followed by a 4 week recovery with 1 -dodecene, homopolymer, hydrogenated (Cooper, 1995), rats were dosed with 0, 1000, 7000, or 50,000 ppm (equivalent to 77.5, 553.7, or 4159.4 mg/kg, respectively, in males and 85.5, 611.5, and 4619.9 mg/kg, respectively, in females). No mortalities were observed in any treated group. Clinical signs observed in the 50,000 ppm group included oily and ungroomed coats as well as a slight increase in food consumption, including during the four week recovery period. Increased erythrocyte counts and hemoglobin concentrations (dose-response relationship) were reported for treated males. Marginally high packed cell volumes were reported for males treated at 7000 and 50,000 ppm. Platelet counts were slightly higher 50,000 ppm animals and slightly reduced liver weights were reported in males at end of treatment. All effects were not present at the end of the 4 week recovery period and therefore considered reversible. In a 90-day one-generation reproduction study with subchronic toxicity with 1 -dodecene, trimer, a structural analogue for poly alpha olefins (Knox et al., 2007, OECD 415/OECD 408), there were no signs of clinical toxicity, changes in body weight, haematological or clinical chemistry changes. The NOAEL was reported as 1000 mg/kg bw. In a 91-day oral repeated dose study (Daniel, 1994), rats exposed to Ethylflo 166 in utero were treated with Ethylflo 166 at doses of 0, 250, 500, or 1000 mg/kg/day. Transient changes in body weight, body weight gain, food consumption, haematology, and organ weights were observed but were not considered treatment-related. The NOAEL was reported as 1000 mg/kg bw/day.  

 

No significant or enduring toxicological effects were reported from these studies; therefore classification and labelling was not required for this endpoint.

 

Justification for Read Across

 

Several criteria justify the use of the read across approach to fill data gaps for poly alpha olefins using 1 -dodecene, trimer as an analogue. 1 -dodecene, trimer, like other compounds in this category, is a poly alpha olefin, i. e., highly branched isoparaffinic chemicals produced by oligomerization of oct-1-ene, dec-1-ene, and/or dodec-1-ene. Therefore its physiochemical and toxicological properties are expected to be similar to those of other poly alpha olefins.

Justification for classification or non-classification

Using read-across information from studies performed with poly alpha olefins within category or from a structural analogue, it can be assumed that dec-1-ene, dimers, hydrogenated would not produce significant systemic toxicity following repeated exposure. Therefore, dec-1-ene, dimers, hydrogenated is not classified under EU Dangerous Substances Directive 67/548/EEC or CLP EU Regulation 1272/2008 for repeated dose toxicity.