Registration Dossier
Registration Dossier
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EC number: 218-817-8 | CAS number: 2243-62-1
Carcinogenicity
Administrative data
Description of key information
Carcinogenicity:
A long term experiment with Fischer-344 -rats was performed. The rats received the test substance in food for 103 weeks [0.05 or 0.1 % in diet (ca. 33 or 67 mg/kg/d)].
There was no significant positive association between the administered dose of 1.5-naphthylenediamine and mortality in either sex of the rats; in all groups adequate numbers of animals survived sufficiently long to be at risk from late-developing tumors (males: high dose: 37/50 = 74 %, low dose group: 40/50 = 80 %, control: 17/25 = 68 %; females: high dose: 38/50 = 76 %, low dose: 38/50 = 76 %, control: 26/25 = 64 %); the weight development of the dosed rats was comparable to controls; among dosed female rats, a statistically significant (p=0.003) increase in endometrial stromal polyps was diagnosed; several of these benign tumors underwent malignant transformation to stromal sarcomas; the incidence of female rats showing either adenoma or carcinoma of the clitoral gland was statistically significant (Cochran-Armitage test indicated a positive association between dose and tumors: p=0.003; Fischer exact test compared high dose to controls: p=0.021); for females the Fisher exact test comparing control to low dose for combined incidence of C-cell carcimoma of the thyroid had a probability level of p=0.46, a marginal result, not regarded as significant by the investigators; no neoplasms were observed at statistically significant increased incidences in treated male rats; the authors stated that based on lack of clinical signs or weight loss, the male rats may have been able to withstand a higher dose; under the conditions of this bioassay, the test substance was carcinogenic in female rats, causing clitoral and uterine neoplasms (NCI 1978).
Gold et al. calculated a median tumor-inducing dose (TD50) for the uterine neoplasms with 69.6 mg/kg (Gold 1986).
Hasemann published that benign stromal polyps were observed relative frequently as spontaneous tumors in Fisher 344 rats (Hasemann ...
Key value for chemical safety assessment
Justification for classification or non-classification
Additional information
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