![]() ![]() A pelleted diet (Rodent 2018C Teklad Global Certified Diet, EnvigoRMS(UK) Limited, Oxon, UK) was used. The animals were allowed free access to food and water. Animal Care and Husbandry The animals were housed individually in solid-floor polypropylene cages with stainless steel mesh lids furnished with softwood flakes (Datesand Ltd., Cheshire, UK). On arrival the females weighed 182 to 304 g. The day that positive evidence of mating was observed was designated Day 0 of gestation. Animals were delivered in two batches containing females prior to Day 3 of gestation. ![]() deficiencies: guideline study Qualifier: according to guideline Guideline: OECD Guideline 414 (Prenatal Developmental Toxicity Study) Deviations: no GLP compliance: yes Limit test: no Specific details on test material used for the study: Identification : 2,3-epoxypropyl neodecanoate Physical State/Appearance : Colorless clear liquid Purity : 100% Batch Number : PV7G0064 Label : CARDURA (TM) E-10P, Lot Number: PV7G0064, Date Received : 02 March 2018 Storage Conditions : Room temperature in the dark Expiry Date : 02 March 2019 Species: rat Strain: Sprague-Dawley Details on test animals or test system and environmental conditions: Animal Information A total of ninety-six time-mated female Sprague-Dawley Crl:CD (SD) IGS BR strain rats were obtained from Charles River (UK) Limited, Margate, Kent. Reference Endpoint: developmental toxicity Type of information: experimental study Adequacy of study: key study Reliability: 1 (reliable without restriction) Rationale for reliability incl. Pending approval of the Stubstance Test Plan by E.C.H.A.Įffects on developmental toxicity Description of key information Reporductive Toxicity Study in rats by the oral route is proposed 443 Testing Guideline Extended One-Generation Therefore, the Interim TWA Reproductive Worker Inhalation DNEL =Īn O.E.C.D. The total Assessment Factor applied to the 88.2 mg/m3 value isġ5x. = 2.5x Intraspecies (worker) = 3x Study Duration (subacute to chronic) 8 -3, page 27).įollowing ECHA Guidance the Assessment Factors applied are: Interspecies ![]() (ECHA RIP 3.2, Chapter R.8: Characterization of dose Inhalation value of approximately 88.2 mg/m3 following ECHA Guidance Oral study that did not demonstrate any histopthological evidence ofĪdverse reproductive effects. Toxicity Study in rats is proposed pending approval of the StubstanceĪ NOAEL of approximately 100 mg.kg/day was observed in the rat 90 -day 443 Testing Guideline Extended One Generation Reproduction Exposure related observations in humans: other dataĪn O.E.C.D.Direct observations: clinical cases, poisoning incidents and other.Exposure related observations in humans.Endocrine disrupter mammalian screening – in vivo (level 3).Toxicity to reproduction: other studies.Developmental toxicity / teratogenicity.Toxicokinetics, metabolism and distribution.Nanomaterial radical formation potential. ![]() Nanomaterial crystallite and grain size.Nanomaterial agglomeration / aggregation.Additional physico-chemical properties of nanomaterials.Additional physico-chemical information.Storage stability and reactivity towards container material.Stability in organic solvents and identity of relevant degradation products.Solubility in organic solvents / fat solubility.Particle size distribution (Granulometry). ![]()
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