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EC number: 607-384-4 | CAS number: 244768-32-9
In a combined 28-day repaeated dose toxicity study with the reproduction/developmental toxicity screening test, the test substance was administered daily to rats at dose levels up to 1000 mg/kg bodyweight/day (OECD 422; van Otterdijk, 2017). The parental and reproduction NOAEL was established as at least 1000 mg/kg/day. The test item is not to be classified as a reproductive toxicant according to the CLP Regulation.
Toxicity to reproduction
A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test was performed in rats, according to OECD guideline 422 (Van Otterdijk, 2017). Ten male and 10 female rats/dose were exposed to T002488 in propylene glycol as vehicle at 0, 100, 300 and 1000 mg/kg bw/day by oral gavage. The The vehicle used was propylene glycol and the test solutions were prepared daily and administered within 6 hours of preparation.
Accuracy and homogeneity of formulations were demonstrated to be acceptable by chemical analyses.
No adverse effects on parental parameters were noted up to 1000 mg/kg. There was a slightly increased incidence and/or severity of follicular cell hypertrophy in males at 1000 mg/kg and in females at 300 and 1000 mg/kg. This was regarded to be an adaptive change and considered to be non-adverse at the incidences and severities recorded. A few changes in clinical pathology parameters were noted at 300 and 1000 mg/kg that were potentially related to treatment. These were not considered adverse in absence of any morphological correlates and since they essentially remained within the range considered normal for rats of this age and strain. These changes consisted of higher activated partial thromboplastin time in females at 300 and 1000 mg/kg and higher inorganic phosphate in males at 1000 mg/kg. No treatment-related effects on mortality, clinical appearance, functional observations, body weight, food consumption, organ weights and macroscopic appearance were observed.
No treatment-related changes were noted in any of the reproductive parameters investigated such as mating and fertility indices, precoital time, number of implantations, estrous cycle, spermatogenic profiling, and histopathological examination of reproductive organs up to 1000 mg/kg.
No treatment-related changes were noted in any of the developmental parameters investigated (i.e. gestation, viability and lactation indices, duration of gestation, parturition, sex ratio, maternal care and early postnatal pup development consisting of mortality, clinical signs, body weight, anogenital distance (PND 1), areola/nipple retention (PND 13 males), T4 thyroid hormone levels (PND 13-15) and macroscopy) up to 1000 mg/kg.
The Parental, Reproduction and Developmental NOAEL were established as at least 1000 mg/kg bw/day.
In the combined 28 -day repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD422, Van Otterdijk, 2017), a developmental NOAEL of 1000 mg/kg body weight/day was established. The test substance is not to be classified as reproductive toxicant.
Based on the results of the OECD 422 study, the following No Observed Adverse Effect Levels (NOAEL) were derived:
Parental NOAEL: at least 1000 mg/kg.
Reproduction NOAEL: at least 1000 mg/kg.
Developmental NOAEL: at least 1000 mg/kg.
Therefore, the substance is not to be classified as a reproductive toxicant according to the CLP Regulation.
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