Irritation / Intracutaneous Reactivity

In-vivo assays assessing the potential of test articles to cause irritation on exposed parts of the body.

Irritation Testing Services

Irritation tests are in-vivo assays to assess the potential of test articles (or test article extracts) to cause irritation on the exposed part of the body. Standard studies are single exposure evaluations. Based on clinical product use, studies may be customized for evaluation of repeat exposures.

Testing Capabilities

  • Intracutaneous
  • Dermal
  • Oral/mucosal
  • Ocular
  • Vaginal
  • Rectal
  • Bladder
  • Penile

Testing Categories and Specifications

Test NameSample NeededTurn-Around Time
Intracutaneous Injection1 Extract: 120 cm² < 0.5 mm thick, 60 cm² ≥ 0.5 mm thick, or 4 g
2 Extracts: 240 cm² < 0.5 mm thick, 120 cm² ≥ 0.5 mm thick, or 8 g
3 Extracts: 360 cm² < 0.5 mm thick, 180 cm² ≥ 0.5 mm thick, or 12 g
4 Extracts: 480 cm² < 0.5 mm thick, 240 cm² ≥ 0.5 mm thick, or 16 g
Direct Exposure: 10 mL
4-5 weeks
Primary Skin Irritation1 Exposure/1 Extract: 120 cm² < 0.5 mm thick, 60 cm² ≥ 0.5 mm thick, or 4 g
1 Exposure/2 Extracts: 240 cm² < 0.5 mm thick, 120 cm² ≥ 0.5 mm thick, or 8 g
Direct Exposure: 6 pieces at 2.5 cm x 2.5 cm, or 4 g
5-6 weeks
Primary Ocular Irritation1 Exposure/1 Extract: 120 cm² < 0.5 mm thick, 60 cm² ≥ 0.5 mm thick, or 4 g
1 Exposure/2 Extracts: 240 cm² < 0.5 mm thick, 120 cm² ≥ 0.5 mm thick, or 8 g
Direct Exposure: 5 mL
5-6 weeks
Primary Buccal (Oral Mucosal) Irritation1 Exposure/1 Extract: 120 cm² < 0.5 mm thick, 60 cm² ≥ 0.5 mm thick, or 4 g
1 Exposure/2 Extracts: 240 cm² < 0.5 mm thick, 120 cm² ≥ 0.5 mm thick, or 8 g
Direct Exposure: 4 g
7-8 weeks
Bladder Irritation with Histology1 Extract: 800 cm² < 0.5 mm thick, 400 cm² ≥ 0.5 mm thick, or 32 g, or 150 mL
2 Extracts: 40 g
Direct Exposure: 150 mL
4-5 weeks
Vaginal Irritation with Histology1 Extract: 240 cm² < 0.5 mm thick, 120 cm² ≥ 0.5 mm thick, or 8 g
2 Extracts: 480 cm² < 0.5 mm thick, 240 cm² ≥ 0.5 mm thick, or 16 g
Direct Exposure: 20 mL
4-6 weeks
Rectal Irritation with Histology1 Extract: 120 cm² < 0.5 mm thick, 60 cm² ≥ 0.5 mm thick, or 4 g
2 Extracts: 2470 cm² < 0.5 mm thick, 120 cm² ≥ 0.5 mm thick, or 8 g
Direct Exposure: 20 mL
4-6 weeks
Penile Irritation with Histology1 Extract: 120 cm² < 0.5 mm thick, 60 cm² ≥ 0.5 mm thick, or 4 g
2 Extracts: 240 cm² < 0.5 mm thick, 120 cm² ≥ 0.5 mm thick, or 8 g
Direct Exposure: 20 mL
4-6 weeks