Acute eye irritation and dermal irritation testing MCQs With Answer

Acute eye irritation and dermal irritation testing are critical components of safety assessment in pharmaceutical development. This blog provides M.Pharm students with focused multiple-choice questions that cover regulatory guidelines, classical in vivo methods, validated in vitro alternatives, scoring systems, and interpretation of results. Emphasis is placed on OECD test guidelines, the Draize scoring variables, in vitro assays like BCOP, ICE, HET‑CAM and reconstructed human epidermis models, and the ethical 3Rs framework. The questions are designed to deepen conceptual understanding and prepare students for exams and practical decision-making in toxicological screening and regulatory submission strategies.

Q1. Which OECD test guideline specifically addresses acute eye irritation and corrosion in vivo?

• OECD TG 404
• OECD TG 405
• OECD TG 439
• OECD TG 431

Correct Answer: OECD TG 405

Q2. The term “Draize test” commonly refers to which experimental procedure?

• In vivo rabbit eye test
• Bovine Corneal Opacity and Permeability (BCOP) test
• HET‑CAM (hen’s egg test on the chorioallantoic membrane)
• EpiOcular in vitro assay

Correct Answer: In vivo rabbit eye test

Q3. In Draize eye scoring, the iris is evaluated using which score range?

• 0–2
• 0–3
• 0–4
• 0–5

Correct Answer: 0–2

Q4. The BCOP assay quantifies ocular effects primarily by measuring which two endpoints?

• Corneal opacity and permeability
• Corneal thickness and surface pH
• Endothelial cell count and opacity
• Corneal collagen breakdown and permeability

Correct Answer: Corneal opacity and permeability

Q5. OECD TG 439 is the guideline for which in vitro method?

• Reconstructed human epidermis test for skin irritation
• Bovine Corneal Opacity and Permeability (BCOP)
• HET‑CAM (hen’s egg chorioallantoic membrane)
• Isolated chicken eye (ICE) assay

Correct Answer: Reconstructed human epidermis test for skin irritation

Q6. According to OECD TG 439, tissue viability at or below which percentage typically indicates an irritant (GHS Category 2) response?

• ≤50%
• ≤20%
• >75%
• Between 60% and 80%

Correct Answer: ≤50%

Q7. Which test uses the chorioallantoic membrane of a fertilized hen’s egg as the biological substrate?

• HET‑CAM
• BCOP
• EpiOcular
• Isolated chicken eye (ICE)

Correct Answer: HET‑CAM

Q8. The “3Rs” principle in animal testing stands for which of the following?

• Replace, Reduce, Refine
• Randomize, Repeat, Report
• Remove, Reduce, Reuse
• Reduce, Recycle, Reuse

Correct Answer: Replace, Reduce, Refine

Q9. In the OECD TG 404 skin irritation test in rabbits, which two lesions are the primary endpoints for scoring?

• Erythema and edema
• Corneal opacity and iris damage
• Conjunctival redness and chemosis
• Hemorrhage and coagulation

Correct Answer: Erythema and edema

Q10. The Primary Irritation Index (PII) is calculated principally from which data?

• Erythema and edema scores averaged over the observation period
• Corneal opacity and permeability readings
• Iris and conjunctival chemosis scores
• Hemorrhage, coagulation, and lysis times

Correct Answer: Erythema and edema scores averaged over the observation period

Q11. Which of the following pH values is most likely to cause chemical corrosion/strong irritation on contact with skin or eye?

• pH 7.0
• pH 5.0
• pH 12.0
• pH 9.0

Correct Answer: pH 12.0

Q12. The acronym “ICE” in ocular testing stands for which assay?

• Isolated Chicken Eye
• In vitro Corneal Evaluation
• Isolated Cornea Experiment
• Internal Corneal Examination

Correct Answer: Isolated Chicken Eye

Q13. The EpiOcular assay models which human tissue for eye irritation testing?

• Reconstructed human corneal epithelium
• Reconstructed human epidermis (skin)
• Reconstructed human conjunctiva
• Reconstructed human stromal tissue

Correct Answer: Reconstructed human corneal epithelium

Q14. Which in vitro assay is commonly used as a complementary follow-up to BCOP for borderline eye irritation results?

• Isolated Chicken Eye (ICE)
• HET‑CAM
• In vivo Draize rabbit eye test
• EpiDerm skin irritation test

Correct Answer: Isolated Chicken Eye (ICE)

Q15. Under the Globally Harmonized System (GHS), which category denotes “serious eye damage”?

• Category 1
• Category 2
• Category 2A
• No category

Correct Answer: Category 1

Q16. In OECD TG 404 dermal irritation testing, observations for erythema and edema are typically recorded at which standard time points after dosing?

• 1, 24, 48 and 72 hours
• 3, 7 and 14 days
• 30 minutes, 2 hours and 6 hours
• Only at 24 hours

Correct Answer: 1, 24, 48 and 72 hours

Q17. Which ocular endpoint most directly indicates the risk of structural damage to the cornea?

• Corneal opacity
• Iris redness
• Conjunctival redness
• Chemosis

Correct Answer: Corneal opacity

Q18. The opacity measurement in BCOP primarily assesses what physical property of the cornea?

• Light transmission through the cornea
• Tissue viability by MTT reduction
• Hemorrhage on the chorioallantoic membrane
• Surface pH change of the cornea

Correct Answer: Light transmission through the cornea

Q19. Which international framework/guideline set explicitly promotes use of validated in vitro methods and tiered testing strategies before conducting animal tests?

• OECD testing guidelines
• USP monographs
• National Pharmacopoeia translations
• General clinical trial guidance

Correct Answer: OECD testing guidelines

Q20. Which of the following best describes a recommended non‑animal tiered strategy for initial eye irritation classification?

• In vitro battery combining BCOP, EpiOcular and ICE assays
• Immediate Draize rabbit eye test without prior screening
• Human volunteer instillation as first step
• No testing and assume non‑irritant

Correct Answer: In vitro battery combining BCOP, EpiOcular and ICE assays

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