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EC number: 701-252-0 | CAS number: -
In a combined repeated dose toxicit/reproscreening study, which was performed in accordance with OECD 422 and under GLP-conditions, standolized linseed oil was administered by daily oral gavage to male and female Wistar Han rats at dose levels of 150, 450 and 1000 mg/kg/day. Males were exposed for 2 weeks prior to mating, during mating, and up to termination (for 29 days). The females were exposed for 2 weeks prior to mating, during mating, during post-coitum, and at least 4 days of lactation (for 42-45 days). No chemical analyses were conducted, since no analytical method could be developed for formulations of the test substance in corn oil.
No parental toxicity attributable to treatment with Standolized linseed oil was observed at any dose level. One female at 1000 mg/kg (Group 4) had a total litter loss and was euthanized in extremis on Day 2 of the lactation period. At histopathology, severe atrophy of the lympho-hemopoeitic system was determined to be the cause of morbidity for this animal. This was considered to be spontaneous in nature. In the absence of similar findings in any other animal, it was not considered to be treatment related, and her total litter loss was considered to be secondary to the poor health of the dam. A number of clinical biochemistry changes were noted at 450 and/or 1000 mg/kg which included higher bilirubin, creatinine and sodium levels in blood. In addition, liver to body weight ratios were increased for both sexes at 1000 mg/kg. Means of these changes only just exceeded or remained within the range considered normal for rats of this age and strain. Moreover, there were no histopathological correlates that would support these changes. Therefore, these changes were considered not to be of toxicological relevance. Overall, no toxicologically relevant changes were noted in any of the parental parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination).
In conclusion, treatment with standolized linseed oil by oral gavage in male and female Wistar Han rats at dose levels of 150, 450 and 1000 mg/kg body weight/day revealed no parental toxicity up to 1000 mg/kg body weight/day. Based on these results, a No Observed Adverse Effect Levels (NOAEL) of at least 1000 mg/kg/day was derived.
Based on Read Across to Standolized linseed oil, Standolized soybean oil does not have to be classified for repeated dose toxicity in accordance with the criteria outlined in Annex I of CLP (1272/2008/EC) and Annex VI of DSD (67/548/EEC).
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