Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

The dermal sensitization potential of the test article was determined in guinea pigs. The study was conducted in accordance with OECD GLP (1999). The test method was based on EU Method B.6 (1996), OECD Guideline 406 (1992), and U.S. EPA: OPPTS: 870.2600 (1998). On Study Day 1, female guinea pigs (10, test group) were induced with 0.1 mL of 5% test article in Tylose by intradermal injection in the dorsal region (2x4 cm). A control group (5 female) was exposed in the same manner without the addition of the test article. Two intradermal injections per animal of 50% Freund's Adjuvant, 5% test substance in Tylose, and test article mixture in 50% Freund's Adjuvant were administered. The injection sites were left uncovered. On Study Day 8, the second induction exposure of 0.5 mL of 25% test article in Tylose was administered to a 2 x 4 cm cellulose patch. The patch was placed over the area where the intradermal injections were administered. The exposure area was kept under an occlusive bandage for 48 hours. No treatment was conducted from Study Days 11-21. On Study Day 22, the challenge exposure of 0.5 mL of 25% test article in Tylose was administered on a 2 x 4 cm cellulose patch. The administration area was kept under an occlusive bandage for 24 hours. Approximately 24 and 48 hours after the removal of the patches the exposure area was examined for erythema and edema according the the Magnusson/Kligmann scale. Body weights (Day -1 and Day 25) and clinical signs (Daily) were recorded. The body weight gains of the animals were not impaired. The treated animals showed no clinical signs of toxicity throughout the study. No skin reactions were observed in the control and treatment group 24 and 48 hours after removal of the challenge patch. Based on the results of the study, the test article showed no evidence for dermal sensitization potential.


Migrated from Short description of key information:
A guinea pig maximization test was conducted on MV31. The result of the study was:

Non-sensitizing in a guinea pig maximization test according to OECD 406.

Justification for classification or non-classification

Criteria for classifying as a dermal sensitizer are not met.