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EC number: 203-618-0 | CAS number: 108-80-5
Repeat dose studies by the oral route have been conducted ( 59 day, 13 week (according to OECD guideline 408) and 104 weeks (according to EU Method B.33) on cyanuric acid or sodium cyanurate monohydrate.
All values were within the normal range. Occasional values were statistically significant, although the absolute differences were small. Albumin, globulin and serum protein values were slightly elevated in high dose males which may be suggestive of hemoconcentration, although water consumption and urine volume were normal.
All values were within the normal range. Occasional values were statistically significant, although the absolute differences were small. Glucose values for males and females at the 4000 ppm dosage level were significantly greater than the control values, although the difference between the high dose and control values was not. All values were within the normal range for this laboratory
Urine values were within the normal range, except for urea nitrogen which was significantly decreased in female rats at 1200 ppm and in both male and female rats at 4000 and 8000 ppm, by around 50%.
No statistically significant organ weight variations of livers and kidneys were noted
Gross and histopathology:
No gross or microscopic lesions of treatment-related significance were noted
No clinical signs considered compound related through 13 weeks of the study. Corenal opacity was noted frequently for control and treated rats. No changes considered compound related occurred in survival, body weights, food or water consumption throughout the study.
Although there were statsitically significant changes in some biochemical values, these were of a random nature and therefore were of equivocal biological significance and not considered related to the compound.
There were no macroscopic changes which could be attributed to the compound. There were no compound related variations in organ weights. Histologically, hyperplasia of the urinary bladder epithelium resulted from compound treatment in males but not the females. This lesion was present at the 6, 8 and 10 week interim sacrifice, and at terminal sacrifice. Based on the incidence pattern found in terminal sacrifice and interim sacrifice rats, it is concluded that hyperplasia of the urinary bladder epithelium was compound related in the male but not the female rats in this study.
Sodium cyanurate was administered in the drinking water in a two year toxicity and oncogenicity study in rats. Non-neoplastic lesions were observed in urinary tracts of males in the 5375 ppm group sacrificed at the 6 and 12 month interims. Heart and urinary tract lesions occurred in 5375 ppm males which died or were sacrificed in extremis during the first 12 months of the study. The only possible substance related changes in females were in the urinary tract of the 5375 ppm animals which died or were sacrificed in extremis during the 6 – 12 month period of study. In the 18 month interim sacrifice and the 24 month terminal sacrifice no lesions were detected which could be attributed to treatment with the test article.
No evidence of test article related carcinogenic effect was observed in any tissues or organs examined microscopically from male or female rats of any test group.
The NOAEL for sub-chronic effects (90-days) is 109 mg/kg bw/day for males based on hyperplasia in the urinary bladder observed in one male in the mid-dose group (Rajasekaran, D (1981) The hyperplasia in males observed in the sub-chronic study has been elucidated in the 2-year combined chronic toxicity and cytogenicity study (Blair, M 1985) where it was seen that male rats were more susceptible to dose related effects during the early stages of the study with reversal of effects over the full dosing period. A small group of male rats were found to be more sensitive to the test material at an early stage of the study, which was considered unusual with chronic toxicity testing. In high dose males the main effects observed were heart and urinary tract lesions. The No Observed Effect Level (NOEL) in males from the 2-year study was identified as 154 mg/kg bw/day and the Lowest Observed Adverse Effect Level in the male was 371 mg/kg bw/day. The low sub-chronic NOAEL (109 mg/kg bw/day, male) should be considered as redundant based on the findings of the 2-year chronic study. The NOEL for males of 154 mg/kg bw/day from the 2-year combined chronic toxicity/carcinogenicity study is applicable for risk characterisation as a precautionary approach.
CYA has shown no evidence of carcinogenicity via oral exposure in drinking water in doses up to 5375 ppm (equivalent to doses of 1523 mg/kg bw/day for males, and 1582 mg/kg bw/day for females), in carcinogenicity studies in both rat and mouse.
In vivo and in vitro studies dermal absorption have been performed which demonstrate that very little cyanuric acid is absorbed through the skin. An in vivo study of cyanuric acid exposure in swimming pool water demonstrated that during swimming uptake is largely by the oral route with dermal uptake being considerably lower (Duncan RC (1980). An in vitro study of rat, guinea pig and human skin exposed to swimming pool water containing 55 mg/l cyanuric acid showed that cyanuric acid is poorly absorbed through the skin (Moody RP et al 1993). Inokuchi, N et al (1978) demonstrated in an in vivo skin absorption study that very little radiolabelled isocyanuric acid (1-3%) was taken up by the skin.
No systemic toxicological findings could be detected after repeated administration of cyanuric acid by either the oral or dermal route. Therefore, a classification as STOT RE is not justified.
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