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EC number: 281-928-5 | CAS number: 84066-92-2
Under the conditions of the present study, single dermal application of the test item Formaldehyde, reaction product with ethylenediamine to rats at a dose of 2000 mg/kg body weight was associated with neither mortality nor signs of toxicity but signs of irritation. The dermal LD50 was determined to be > 2000 mg Formaldehyde, reaction product with ethylenediamine / kg body weight.
On the basis of this 28-Day Repeated Dose Oral Toxicity study with formaldehyde, reaction products with ethylenediamine in male and female Wistar rats with dose levels of 100, 300, and 800 mg/kg body weight day, the following conclusions can be made:
At 800 mg/kg BW increased clinical symptoms were found which indicate discomfort of the animals. Furthermore, decreased thymus weight as well as increased adrenal weight indicates stress of the animals, too. An additional tissue besides the stomach occurred probably due to the local irritant effect of the test item. Pathologically, test item-related lesions of toxicological significance were seen in the kidney and comprised mild or moderate tubular degeneration/regeneration at the inner cortex in all rats treated at 800 mg/kg/day. Hence, the dosage of 800 mg/kg BW is assumed to induce adverse effects within this study.
In MD group, clinical signs of discomfort were found. Furthermore, decreased thymus weights indicate stress, too. A non significant increase of TBA in serum is not confirmed by other liver markers or histopathology. Furthermore, histological analysis do not confirm the adverse kidney findings in this MD dose level. Hence, the MD dose is assumed to induce stress and discomfort of the animals. However, these findings were mostly related to the local irritant effects of the test item. Hence, an adverse effect, relevant in humans, cannot be stated. The No Observed Adverse Effect Level is assumed to be 300 mg/kg BW within this study (MD group).
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