Dicyclohexylamine was studied for oral toxicity in rats in an OECD preliminary reproduction toxicity screening test at doses of 0, 20, 40 and 80 mg/kg/day.
With regard to repeat dose toxicity, 1 dam of the 80 mg/kg group died on day 21 and another on day 22 of gestation. In the same group, suppression of body weight gain in both sexes and low food consumption were observed. However, no effects of administration of dicyclohexylamine were noted in the groups treated with 40 mg/kg or less. The NOEL for repeat dose toxicity is considered to be 40 mg/kg/day.
With regard to reproductive/developmental toxicity, abnormal nursing behavior was observed in the 80 mg/kg group. The viability index and body weight of F1 pups on days 0 and 4 of lactation were also low in this group. However, no effects of administration of dicyclohexylamine were noted in the groups treated with 40 mg/kg or less. The NOELs for reproductive and developmental toxicity are considered to be 80 mg/kg/day for males and 40 mg/kg/day for females and their offspring.
| Purity | : | 99.89 % |
| Test species/strain | : | Rat/Crj:CD(SD) |
| Test method | : | OECD Preliminary Reproduction Toxicity Screening Test |
| Route | : | Oral (gavage) |
| Doses | : | 0 (vehicle), 20, 40 and 80 mg/kg/day |
| Number of animals/group | : | Males, 12; females, 12 |
| Vehicle | : | Corn oil |
| Administration period | : | Males, 49 days Females, from 14 days before mating to day 3 of lactation |
| Terminal kill | : | Males, day 50 Females, day 4 of lactation |
| GLP | : | Yes |
Test results:
No effects of administration were noted in terms of clinical signs, body weight, food consumption, gross pathological findings or weights of testis and epidydimis in the groups treated with 40 mg/kg or less. In the 80 mg/kg group, 1 dam of the 80 mg/kg group died on day 21 and another on day 22 of gestation and suppression of body weight gain in both sexes and low food consumption were observed. The NOEL for repeat dose toxicity is considered to be 40 mg/kg/day.
<Reproductive and developmental toxicity>
No effects of administration were noted on the estrous cycle, mating and conception, gestation period or delivery, viability or growth of F1 pups in the groups treated with 40 mg/kg or less. In the 80 mg/kg group, abnormal nursing behavior was observed and the viability index and body weight of F1 pups on days 0 and 4 of lactation were low in this group. The NOELs for reproductive and developmental toxicity are considered to be 80 mg/kg/day for males and 40 mg/kg/day for females and their offspring.
| 1) | The test was performed by Bozo Research Center Inc., 1284 Kamado, Gotemba-shi, Shizuoka, 412-0039, Japan. Tel +81-550-82-9912 Fax +81-550-82-2379 |