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DL-LACTONE CAS N°:79-50-5 - page 97 / 113





97 / 113



ID: 79-50-5 DATE: 18.01.2006

housed in labelled polycarbonate cages containing sawdust (SAWI bedding, Jelu Werk, Rosenberg, Germany) as bedding material. Certificates of analysis were examined and then retained in the NOTOX archives. Offspring was kept with the dam until termination. In order to reduce environmental influences as much as possible, cages were arranged in a latin square design over the cage rack during the study period. Each cage was identified with a colour-coded label according to dose group, showing the study number, animal identifications and other experimental details. From arrival until mating, males and females were housed in separate rooms. During the final stage of the pregnancy period (from approximately day 16 of gestation onwards) and during lactation, paper (Enviro-dri, BMI, Helmond, The Netherlands) was supplied to each dam for incorporation in the nest. The paper was analysed for contaminants. This was replaced when soiled.

Diet Free access was allowed to standard pelleted laboratory animal diet (from Altromin (code VRF 1), Lage, Germany). Each batch was analysed for nutrients and contaminants were analysed on a regular basis. Results were examined and then retained in the NOTOX archives. Fresh diet was provided on a weekly basis, or at periodic intervals during pregnancy.

Water Free access was allowed to tap water. Certificates of analysis (performed quarterly) were examined and then retained in the NOTOX archives. Analysis of bedding, diet, paper and water did not reveal any findings that were considered to have affected study integrity.

Test System Rat: male and female Wistar rats Crl: (WI) BR (outbred, SPF-Quality). Untreated animals and virgin females were used at initiation of the studied test system. Source: Charles River Deutschland, Sulzfeld, Germany. Age at start F0-treatment: Approximately 10 weeks. Number of F0-animals: 40 females and 40 males. Acclimatisation F0: 5 days prior to start of treatment. Health check F0: A health inspection was performed prior to commencement of treatment to ensure that the animals were in a good state of health. Randomisation F0: 5 days before study start, by computer-generated random algorithm according to body weight, with all animals within ± 20% of the sex mean. Identification F0: By tattoo on the tail. Mating procedures F0: Females were paired on a one-to-one-basis with males from the same treatment group. Each morning following pairing, the trays under the cages were checked for ejected copulation plugs. The day on which a copulation plug was found was designated day 0 of gestation (=day 0 post-coitum). Once mating had occurred, the males and females were separated. - Mating had not been detected for females 53, 56, 57 (group 2), and 78 (group 4) after one week of pairing. On 14 October 2002, these females were paired with proven males of the same treatment group. Parturition F0: The females were allowed to litter normally. Day 1 of lactation was defined as the day when a litter was



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