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Toxicological information

Carcinogenicity

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Description of key information

Two repeated dose (104 weeks) OECD 451 and GLP compliant studies in rats and mice, respectively, are available. The available data indicate that 2-phenoxyethanol is not carcinogenic.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Two carcinogenicity (104 weeks) OECD 451 and GLP compliant studies are available. A drinking water study was conducted with F344/DuCrlCrlj rats. 50 rats per sex were exposed to nominal concentration of 0, 2500, 5000, and 10000 mg/L. Analytical concentrations in drinking water were determined with HPLC. Based on chemical intake data the mean intake of test substance across the duration of the study was estimated to be 124, 249, and 510 mg/kg/day in males and 191, 380, and 795 mg/kg/day in females. Mortality and clinical signs were investigated. Food intake, water intake and body weight were determined weekly during the first 13 weeks followed by measurements once every 4 weeks until study termination. After 104 weeks urinalysis, haematology, blood chemistry, gross pathology, organ weights and histopathology (both non-neoplastic and neoplastic lesions) were examined. No neoplastic lesions were found in either sex. Additionally, a drinking water study with B6D2F1/Crlj mice was conducted. The study design and examination/observations were similar to the study in rats. However, the dose levels differed and were 0, 5000, 10000 and 20000 mg/L. Based on chemical intake data the mean intake of test substance across the duration of the study was estimated to be 468, 898, and 1701 mg/kg/day for males and 586, 1072, and 2058 mg/kg/day for females. After 104 weeks repeated dosing, no treatment related neoplastic lesions were found in either sex. Based on both rat and mice studies, there is no evidence of carcinogenic activity of the test substance in male or female rat and mice.

Justification for classification or non-classification

Based on the assessment of all available data classification in accordance with EU Directive 67/548/EEC (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 is not warranted