SECTION 11: Toxicological Information

Overview

This section provides a comprehensive overview of the health effects and toxicological properties of the substance/mixture, based on available scientific data and CLP Regulation requirements. The information should align with hazard classifications from Section 3 and exposure controls from Section 8.

Key Toxicological Data Requirements

Parameter Required Information CLP Reference
Acute toxicity LD₅₀/LC₅₀ values by route (oral, dermal, inhalation) Annex I, 3.1
Skin corrosion/irritation Test results and classification rationale Annex I, 3.2
Serious eye damage/irritation In vivo/vitro test outcomes Annex I, 3.3
Respiratory/skin sensitization Guinea pig maximization test (GPMT) or LLNA results Annex I, 3.4
Mutagenicity Ames test, in vitro cytogenetics data Annex I, 3.5
Carcinogenicity IARC classifications or equivalent studies Annex I, 3.6
Reproductive toxicity Teratogenicity, fertility impacts Annex I, 3.7
STOT Target organ effects (single/repeated exposure) Annex I, 3.8-3.9

Toxicokinetic Profile

  • Absorption: Bioavailability through relevant exposure routes
  • Distribution: Tissue distribution patterns
  • Metabolism: Major metabolic pathways (e.g., cytochrome P450)
  • Excretion: Primary elimination routes (renal/hepatic)

Example: Ethanol Toxicokinetics

  • Absorption: Complete GI absorption within 2-6 hours
  • Metabolism: 90% hepatic oxidation via ADH/CYP2E1
  • Excretion: 5-10% unchanged in urine/breath

Acute Effects Overview

Exposure Route Symptoms First Aid Measures
Inhalation Cough, dizziness, respiratory irritation Remove to fresh air
Skin Contact Erythema, chemical burns Wash with water 15+ minutes
Eye Contact Corneal damage, conjunctivitis Immediate irrigation 30 minutes
Ingestion GI irritation, CNS depression Do NOT induce vomiting

Example: Benzene Toxicity Profile

Acute Effects

  • LC₅₀ (inh): 10,000 ppm/7h (rat)
  • LD₅₀ (oral): 930 mg/kg (mouse)

Chronic Effects

  • IARC Group 1 carcinogen (leukemia)
  • STOT-RE: Hematopoietic system damage
  • Reproductive: Ovarian atrophy in chronic exposure

Biomonitoring

  • Urinary S-phenylmercapturic acid >50 μg/g creatinine indicates exposure

Testing Standards Reference

Test OECD Guideline CLP Relevance
Acute Oral Toxicity TG 423 Cat 1-4 Classification
Skin Sensitization TG 406 (GPMT) Cat 1 Determination
Prenatal Toxicity TG 414 Developmental Effects
In Vitro Genotoxicity TG 487 Mutagenicity Assessment

Health Monitoring Recommendations

  • Baseline biological monitoring for exposed workers
  • Regular pulmonary function tests for respiratory sensitizers
  • Annual hematological screening for benzene-exposed personnel