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EC number: 271-237-7 | CAS number: 68526-89-6 A complex combination of hydrocarbons produced by the distillation of products from the hydrogenation of isononanal from the hydroformylation of octene. It consists predominantly of C9-10 primary aliphatic alcohols, C10-20 dimer alcohols, C>18 acetals and esters and C>18 acid sodium salts and boils in the range of approximately 200°C to 400°C (392°F to 752°F).
oral: NOAEL = 1000 mg/kg bw/day (BASF SE/Evonik, 30S015/08095, 2014, OECD Guideline 408)
Sub-acute study (OECD 407)
In a subacute toxicity study (OECD 407, BASF AG, 30S015/08095, 2004) the test substance was administered to 5 Wistar rats/sex/dose by gavage at dose levels of 0, 100, 300, and 1000 mg/kg bw/day for 28 days. There were no compound related adverse effects in mortality, clinical signs, food consumption, hematology, clinical chemistry, urinanalysis, organ weights, or gross and histologic pathology. In the 1000 mg/kg bw/day group the body weight was lower (not significantly) in male animals from study day 14 onwards. Body weight change was significantly lower by -17.47% in males on study day 21.In conclusion, with regard to body weight parameters the oral administration of the test substance by gavage over a period of 4 weeks revealed signs of toxicity in male Wistar rats at dose levels of 1000 mg/kg bw/day but none in female Wistar rats. Salivation was considered to be related to either the bad taste of the test substance or local affection of the upper digestive tract. This finding was not considered to be an adverse and toxicologically relevant effect. Therefore, under the conditions of the present study, the no observed adverse effect level (NOAEL) was 300 mg/kg bw/day for male and 1000 mg/kg bw/day for female Wistar rats. This subacute study in the rat is acceptable and satisfies the guideline requirements for a subacute oral study OECD 407 in rats.
Subchronic Study (OECD 408):
Oxooel 9N was administered by gavage to groups of 10 male and 10 female Wistar rats at dose levels of 0 (test group 0), 100 (test group 1), 300 (test group 2) and 1000 mg/kg bw/d (test group 3) over a period of 3 months. With regard to clinical examinations, signs of general systemic toxicity were not observed even at a dose level of 1000 mg/kg bw/d. In addition, no test substance-related effects on estrous cycle length and the number of cycles were obtained. Concerning clinical pathology, no treatment-related, adverse effects were observed up to a dose level of 1000 mg/kg bw/d. Furthermore, no test substance-related effects on sperm parameters were obtained.
Regarding pathology, target organs were the kidneys of male animals and the liver and thyroid glands of male and female animals. In the kidneys of males, a dose-dependent increase of α2u-globuline was observed starting from test group 1 (100 mg/kg bw/d), which explains the significant absolute and relative weight increase in the kidneys of males of test groups 2 and 3 (300 and 1000 mg/kg bw/d). α2u-Globulin is a male and rat-specific poor soluble protein synthesized in the male rat liver, filtered by the glomerulus and reabsorbed in the S2 segment of the proximal tubules where it is slowly hydrolyzed by lysosomal digestion. Reversible binding of the test-substance or their metabolites to α2u-globulin decreases the effectiveness of its lysosomal digestion, resulting in strong accumulation of this protein that is visible in form of characteristic eosinophilic droplets. Although the increase of eosinophilic droplets is considered treatment-related, this finding does not represent a risk for humans since they do not synthesize this protein (Durham and Swenberg, 2013). Multifocal basophilic tubules representing areas of regeneration increased when compared with the control group, but without a clear dose-dependent relationship. Basophilic tubules and granular casts resulted from cell injury induced by intracellular overload of eosinophilic droplets and are characteristic of the rat-specific α2u-nephropathy.
In the liver, diffuse hepatocellular hypertrophy was observed in males and females correlating with statistically significant liver weight increase starting from test group 2 (300 mg/kg bw/d). Since no signs of liver hepatotoxicity (necrosis/single cell necrosis, inflammation, fibrosis, fatty change, etc.) were detected, the hepatocellular hypertrophy associated with liver weight increase was considered to be treatment-related and adaptive (Hall et al., 2012).
In the thyroid gland of males of test groups 2 and 3 (300 and 1000 mg/kg bw/d), minimal to slight hypertrophy/hyperplasia of the follicular epithelium and altered colloid occurred without a clear dose-response. In females of the same test groups, hypertrophy/hyperplasia increased dose-dependently with altered colloid in test group 3 only (1000 mg/kg bw/d). Since all of these changes were not accompanied by significantly increased relative organ weights, this strongly suggests an increased thyroxin catabolism occurring in the liver due to hepatic enzyme induction. This well-known phenomenon is characteristic for rodents (Curran et al., 1991) and there is no convincing evidence that humans exposed to chemicals that induce hepatic microsomal enzymes have increased risk for any thyroid gland disorder (Capen, 1997). Thus, the thyroid gland findings were regarded as treatment-related but not adverse.
All other findings occurred either individually or were equally distributed over control and treatment groups. They were considered to be incidental or spontaneous in origin and without any relation to treatment.
Based on these findings, the NOAEL of the 90 -day oral repeated dose toxicity study according to OECD 408 guideline is 1000 mg/kg/d. Considering that the weight effects observed in animals in the 28 -day repeated dose toxicity study were not confirmed in the study in which animals were exposed three times longer, it can be concluded that these gender-specific weight effects are incidental and do not need to be taken into account.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for repeated oral dose toxicity under Regulation (EC) No. 1272/2008.
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