Registration Dossier
Registration Dossier
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EC number: 639-864-4 | CAS number: 43133-95-5
Carcinogenicity
Administrative data
Description of key information
A two part carcinogenicity study was read across based on data for commercial hexane (Daughtrey, 1999; Klimisch score =2). The studies were conducted on both rats and mice to determine the oncogenic effects of inhalation exposure to commercial hexane (51.5% n-hexane).
Key value for chemical safety assessment
Carcinogenicity: via inhalation route
Endpoint conclusion
- Dose descriptor:
- NOAEC
- 31 680 mg/m³
Justification for classification or non-classification
The negative results suggest that this substance is not carcinogenic.
Additional information
In a two part study, the oncogenic effects of inhalation exposure to commercial hexane (52% n-hexane) were evaluated male and female mice and male and female rats (Daughtrey, 1999; Klimisch score =2). In Part I of the study groups of 50 male and 50 female rats were exposed to 0, 900, 3000, or 9016 ppm of test substance for 6 hrs/day, 5 days/week, for 2 yrs. Mortalities of exposure groups were consistant with control groups. Body weight gain was significantly reduced in exposure groups. Histopathology revealed dose-related irritation-related effects in the nasoturbinal tissue in all exposure groups. Therefore, there was no NOAEC level for local irritation effects. The LOAEC level for both sexes was 900 ppm for irritation. No oncogenic effects were seen in the exposure groups. The NOAEC for systemic effects was 9016 ppm in rats of both sexes.
In Part II of the study groups of 50 male and 50 female mice were exposed to 0, 900, 3000, or 9018 ppm (0, 3168, 10560, 31680 mg/m3) of commercial hexane (52% n-hexane) for 6 hrs/day, 5 days/week, for 2 yrs. Mortalities of exposure groups were consistant with control groups. Histopathology revealed increased liver masses and nodules in female mice at the 9018 ppm exposure group. As referenced by the National Toxicology Program, liver tumors in B6C3F1 mice are known to be sensitive to body weight changes, especially in female B6C3F1 mice. Therefore, the increased incidence of liver masses and nodules in female mice are deemed of questionable relevance for human health risk assessment. Therefore, the NOAEC level for oncogenic effects in mice is 9018 ppm (31680 mg/m3).
This study directly informs the DNEL.
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