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DL-LACTONE CAS N°:79-50-5 - page 75 / 113

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OECD SIDS 5. TOXICITY

DL-LACTONE

ID: 79-50-5 DATE: 18.01.2006

28-JUN-2005

(31)

5.2 Corrosiveness and Irritation

5.2.1 Skin Irritation

Species: Concentration: Exposure: Exposure Time: No. of Animals: Vehicle: PDII: Result: EC classificat.:

rabbit .5 g Semiocclusive 4 hour(s) 3 water 0 not irritating not irritating

Method:

"Acute Dermal Irritation/Corrosion"

OECD Guide-line 404 2005 yes as prescribed by 1.1 - 1.4

Year: GLP: Test substance:

Method:

Test substance preparation The powdery test substance was moistened with water (Milli-U), immediately before application, to ensure close contact with the animal's skin.

Test System New Zealand White Albino Rabbit (SPF-Quality) from Charles River Deutschland, Kisslegg, Germany. The 3 males used within the study were at least 6 weeks old and body weights were at least 1.0 kg. Identification was by earmark.

Animal husbandry Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21±3 °C (actual range: 19.4-21.1 °C), a relative humidity of 30-70% (actual range: 44-59%) and 12 hours artificial fluorescent light and 12 hours darkness per day. Accommodation was individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5 cm). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions. Diet: Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany) approximately 100 g per day. Certificates of analysis were examined and retained in the NOTOX archives. In addition, hay (BMI, Helmond, the Netherlands) was provided at least three times a week. Free access to tap-water was given. Certificates of quarterly analysis were examined and retained in the NOTOX archives. Results of analyses for ingredients and/or contaminants of diet and water were assessed and did not reveal any findings that were considered to have affected study integrity.

Treatment All available data relevant to the potential dermal irritation/corrosivity of the substance indicated that no severe effects were to be expected. An in-vitro test was

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