45890101.DER.pdf

• filename: 45890101.DER.pdf
• MRIDs: 45890101
• CHEMICAL_SUBSTANCE_NAME: Fentin hydroxide
• CHEMICAL_CASRN: 76-87-9
• CHEMICAL_PC_CODE: 083601
• STUDY_CITATION: Taylor, L. (2003) Triphenyltin Hydroxide (TPTH): Milk Secretion Following Single and Repeated Oral Doses to the Rat: Lab Project Number: LDA/036: LDA 036/022277: AZ 08354. Unpublished study prepared by Huntingdon Life Sciences Limited. 198 p. {OPPTS 870.6300}
• STUDY_YEAR: 2003.0
• EXECUTIVE_SUMMARY: TPTH (Fentin hydroxide; Triphenyltin hydroxide): In a non-guideline study (2003, MRID 45890101), groups of lactating Sprague-Dawley [Crl:CD(SD)IGS BR] rats were exposed to Fentin hydroxide (TPTH; 99.4% a.i.; Lot/Batch # AZH 01-00) in corn oil by gavage. In one group, fifteen rats were given a single 4 mg/kg dose and milk samples were collected from 3 rats/time point at 0.5, 1, 3, 6, or 24 hours post-dosing. In a second group, twelve rats were given daily 4 mg/kg doses for 10 days and milk samples were collected on Days 5 or 10 from 6 rats/time point at 6 or 24 hours post-dosing, or on Day 15 (5 days after the final dose) from all 12 rats. It was stated that milk samples were also taken from control groups of 4 lactating rats on 3 separate occasions. Systemic effects: No effects of treatment were observed on clinical signs of toxicity, mortality, or body weight. Transfer to milk: No detectible residue was found in samples from lactating rats dosed with a single 4 mg/kg oral dose of TPTH. On Study Day 5 at 6 hours post-dosing, the mean concentration of parent TPTH was 0.05 µg/mL, while total TPTH (TPTH plus metabolites) was 0.06 µg/mL. By 24 hours post-dosing, parent TPTH concentration was below the limit of detection (LOD; <0.02 µg/mL), while total TPTH concentration was ¿0.03 µg/mL. On Study Day 10 at 6 hours post-dosing, the mean concentration of parent TPTH was 0.09 µg/mL, while total TPTH concentration was 0.10 µg/mL. By 24 hours post-dosing, parent TPTH concentration was below the LOD, while total TPTH concentration was 0.03 µg/mL. On day 15, there was no TPTH or its metabolites in the milk. The data indicate that TPTH will be transferred to the milk of lactating dams at the low level of a maximum of 0.09 µg/mL achieved following multiple oral doses of 4 mg/kg/day for 10 days. This study is classified as Acceptable/Non-guideline.
• STUDY_TYPE: Acute
• GUIDELINE_COMMENT: NA [870.6300, Developmental neurotoxicity study]
• ADMIN_ROUTE: Oral
• DOSE_PERIOD: Treatment Duration: 1 Dose; gavage; also daily dose for 10 days
• txr: 51781.0
• memoDate: 2005-09-28
• UpdateDate: 2016-01-04
• Comments:

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