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DL-LACTONE CAS N°:79-50-5 - page 78 / 113

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OECD SIDS 5. TOXICITY

DL-LACTONE

ID: 79-50-5 DATE: 18.01.2006

5.3 Sensitization

Method:

OECD Guide-line 406 2005 yes as prescribed by 1.1 - 1.4

"Skin Sensitization"

Year: GLP: Test substance:

Method:

Test substance preparation Vehicle: Water (Milli-U) Rationale: The vehicle was selected based on trial formulations performed at NOTOX. Preparation: The test substance formulations (w/w) were prepared within 4 hours prior to each treatment. Homogeneity was obtained to visually acceptable levels.

Type: Species: Concentration 1st:

2nd: 3rd: No. of Animals: Vehicle:

Result: Classification:

Guinea pig maximization test

other: water and FCA for the intracutaneous induction, water for epicutaneous induction and challenge not sensitizing not sensitizing

guinea pig Induction Induction Challenge 15

5 % intracutaneous 50 % occlusive epicutaneous 50 % semiocclusive

Test System Species: Dunkin Hartley strain, albino guinea pig (SPF-quality); recognised by international guidelines as the recommended test system (eg, OECD, EC). Source: Charles River Deutschland, Kisslegg, Germany. Number of animals: Experimental group: 10 females; Control group: 5 females (all females were nulliparous and non-pregnant). Age: Young adult animals (approximately 4 weeks old) were selected. Identification: Ear tattoo. Reliability check: The results of a reliability test performed not more than 6 months previously are given in the Appendix to the test report. Similar procedures were used in the reliability test and in this study.

Animal husbandry Conditions: 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: 19.3-21.8 °C), a relative humidity of 30-70% (actual range: 45-91%) and 12 hours artificial fluorescent light/12 hours darkness per day. Accommodation: Group housing of maximally 5 animals per labelled cage (74 cm x 54 cm x 25 cm height) containing sterilised sawdust as bedding material (Woody-Clean type 3/4;

Tecnilab-BMI BV, Someren, The Netherlands). analysis were examined and retained in the

Certificates of

NOTOX archives. The acclimatisation period was at least 5 days before the start of treatment under laboratory conditions. Diet: Free access to standard guinea pig diet including

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