Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Description of key information

There is no evidence that cyclohexylamine is carcinogenic in rats, mice or dogs. 

Key value for chemical safety assessment

Justification for classification or non-classification

According to the EU classification criteria 67/548/EWG Annex 1 and EU regulation no. 790/2009 (GHS) Annex 1 the compound is not classified. No further classificatio is proposed.

Additional information

There are no studies available that meet present-day guidelines. Comprehensive reviews on all chronic studies are available (Bopp et al., 1986, NL Health Council 2010, MAK 2006). The chronic studies available are discussed in the chapter repeated dose toxicity. There is no evidence that cyclohexylamine is carcinogenic in rats, mice or dogs.

In one carcinogenicity study in rats with a small group size and insufficient documentation groups of rats (25/sex/group) were given doses of cyclohexylamine sulphate of 0, 0.15, 1.5 or 15 mg/kg bw/day for 2 years. No significant difference was reported for food intake, mortality, blood chemistry and heamotological parameters. A single bladder tumor was found in one out of eight male survivors in the high-dose group. There were no treatment-related changes in any of the other organs examined (Price et al. 1970).

This observation was not confirmed by other investigators in more comprehensive studies with higher group size in rats or mice and, consequently, not regarded as an indication of a carcinogenic effect.

Groups of 48 male and female Wistar rats received 600, 2000, 6000 ppm cyclohexylamine hydrochloride in the diet for 2 years. The average intake of cyclohexylamine hydrochloride during the experiment by males was 24, 82, 300 mg/kg bw/day and by females was 35, 120, 440 mg/kg bw/day. These doses correspond to 18, 60, 219 mg/kg bw/day cyclohexylamine for males and 26, 88, 321 mg/kg bw/days cyclohexylamine for females. Mortality was lower in the treated groups than in the control groups. No treatment related increase in any tumor was reported in any dose group. In all dose groups, body weight gain, food and water intake were reduced (Gaunt et al., 1976).

In a multigeneration study, weanling rats (FDRL, 30/sex/group) were given diets containing cyclohexylamine hydrochloride resulting in cyclohexylamine doses of 0, 15, 50 or 150 mg/kg bw/day, for 2 years. This treatment has no influence on the mortality rate. No difference in tumor incidence was found in any organ (including the bladder) between treated and control groups (Oser et al 1976).

In a chronic study with mice (ASH-CSI; 48 males and 50 females/group) animals were dosed with 300, 1000 or 3000 mg cyclohexylamine hydrochloride per kg diet for 80 weeks (Hardy et al., 1976). This concentration is equivalent to approx. 29, 102 or 292 mg cyclohexylamine/kg bw/day (assuming 20 mg bw and 3 g feed per day; MAK 2006). Mortality was not affected. No statistically significant increase in any tumor incidence was reported.

Bopp et al. 1986 reviewed a study in which Beagles dogs (n=3/sex/group) were given daily oral capsules of cyclohexylamine sulphate (0, 0.15,1.5 or 15 mg/kg bw/day. No effects were observed in growth, behavior, heamatology, serum chemistry, urine-analysis or hepathic or renal function tests. One male and one female from each group were sacrificed after one year. Organ weight and histopathology were unaffected in these animals. After about 4 years, the doses were increased to 50, 100 or 150 mg/kg bw/day. Animals lost weight after dose increase (dose groups not reported), but subsequently slowly regained weight. Clinical pathology tests were not affected and no histopathological changes were attributed to the treatment. The study was terminated at the end of the 9.5 year period.