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DL-LACTONE CAS N°:79-50-5 - page 87 / 113

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OECD SIDS 5. TOXICITY

Result:

DL-LACTONE

ID: 79-50-5 DATE: 18.01.2006

Jejunum; Testes (fixed in Bouin’s); Kidneys Thyroid including parathyroid; Lachrymal gl Tongue; Liver; Trachea; Lung (infused with bladder; Lymph nodes (mandibular, mesenteri Nasopharynx; Vagina; Oesophagus; All gross From all adult animals: Cervix; Clitoral gl gland; Epididymides (fixed in Bouin’s); Ova gland; Prostate gland; Seminal vesicles; Te Bouin’s); Uterus; Vagina; All gross lesions Organ weights: Terminal body weight was rec parental animals. The following organ weigh From 5 surviving animals/sex/group: Adrenal Epididymides (total weight for both); Heart

; Thymus; Larynx; and, exorbital; formalin); Urinary c); Uterus; lesions. and; Coagulation ries; Preputial stes (fixed in . orded for all ts were recorded.

glands; Brain; ; Kidneys; Liver;

Spleen; Testes; Thymus. From all adult males: (total weight for both); Testes. Histotechnology: All organ and tissue samples

Epididymides

, as defined

under Histopathology (following), were processed, embedded and cut at a thickness of 2-4 µm and stained with haematoxylin and eosin. Of the selected 5 males/group of the control and high dose group, additional slides of the testes were prepared to examine staging of spermatogenesis. The testes was processed, sectioned at 3-4 µm, and stained with PAS/haematoxylin. Histopathology The following slides were examined by a pathologist: The preserved organs and tissues of the selected animals of groups 1 and 4. - The additional slides of the testes of the selected 5 males/group of groups 1 and 4 to examine staging of spermatogenesis. - The preserved organs and tissues of the animals of all dose groups which died spontaneously or were killed in extremis. - All gross lesions of all animals (all dose groups). - The preserved organs and tissues of all non-pregnant females and animals suspected of infertility. All abnormalities were described and included in the report. Analysis of dose preparations Accuracies were out of the 90-110% range on several days of analysis. It was considered not to be caused by inaccurate preparation of formulations but by analytical problems (i.e. sensitivity fluctuation in time of the LCMSMS system used). For formulations in Milli-U water (19 September 2002), accuracies at a target concentration of 8 mg/g ranged from 84 to 112%. Accuracies at a target concentration of 200 mg/g were between 88 and 91%. For formulations in Milli-U water adjusted to pH 4 (19 September 2002, 09 October 2002, 31 October 2002), accuracies at target concentrations of 8 mg/g ranged from 87 to 134%. Accuracies at a target concentration of 40 mg/g were between 88 and 98%. Accuracies at a target concentration of 200 mg/g were between 80 and 103%. The accuracies of group 4 formulations measured on 23 October 2002 were considered not reliable because concentrations were relatively low at t=0 (68-81% of target) but at target level after 8 days of storage. Homogeneity: The relative standard deviation for the measurements (19 September 2002, 09 October 2002, 31 October 2002) ranged from 1.3 –12% indicating that formulations were homogeneous. The higher relative standard deviation at lower concentration was considered due to the analytical method used. Stability: The measurements on 19 September 2002 showed that concentrations in formulations in Milli-U water

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