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EC number: 944-207-2 | CAS number: -
A NOAEL of 1000 mg/kg was established for this study. No mortality occurred during this study. Low incidences of very slight erythemia, desquamation and/or pinpoint scabbing were observed sporadically in the treated animals. All animals were free of edema during the study. Body weights and food consumption data were unremarkable during the treatment and recovery periods. There were no treatment-related differences from control observed in the hematology data of the treated animals following the dosing or recovery periods. Differences from control were noted for several hematology parameters including a statistically significant increase in the mean percentage of neutrophils of the 300 and 1000 mg/kg females and a decrease in mean percentage of lymphocytes in the 1000 mg/kg females compared to control on day 28. There was a statistically significant decrease in mean percentage of basophils in the satellite females from day 28 to 42. However these values were within the normal range. In the absence of differences from control in absolute white blood cell counts, these findings were considered unrelated to treatment. There was a statistically significant decrease in the mean corpuscular hemoglobin and mean corpuscular hemoglobin concentration of the male satellite animals from day 28 to 42. In the absence of other significant findings in mean hemoglobin or red blood cell parameters, these small differences were not considered clinically significant. Serum chemistry values were unremarkable in the treated animals at termination of the treatment and recovery periods. There was a slight increase in the mean aspartate aminotransferase and alanine aminotransferase of the high dose females at day 28. These increases were attributed to two females with high values. Similar changes were not observed in the satellite females or in the males at day 28. These increases were not considered related to treatment. There were several differences from control noted at the end of recovery. These values were within the range of normal and similar differences were not evident at the end of the treatment period indicating that these findings were not clinically significant or treatment related. Gross postmortem findings were limited to one 300 mg/kg male with small testes, one control female with discolored lungs and liver and black material in the stomach; and single occurrences of scabs in the 100 and 1000 mg/kg and recovery males. These findings were considered incidental and unrelated to treatment. Tape irritation was observed in a number of animals. There were no alterations in organ weights that were attributed to treatment with the test material. Slight alterations were noted in several organ weights at termination of dosing or recovery. There was a statistically significant decrease in mean absolute brain weight of the 300 mg/kg females compared to control. This finding lacked a dose response and was not considered biologically significant. There was a statistically significant decrease in mean relative adrenal and testes weights of the male satellite animals at termination of recovery compared to control at end of treatment. Compared to the high dose at study termination there was a statistically significant decrease in mean relative adrenal, brain and testes weight of the male satellite animals and mean relative adrenal and brain weight of the female satellite animals at recovery termination. These alterations in organ weights were attributed to the cessation of the stress associated with wrapping (adrenal) and the animals continued increase in body weight while organ weights remained constant in adult animals. In the absences of significant organ weight findings following treatment or correlating effects with histopathology these findings were not considered clinically significant. There were no test material related microscopic findings noted in any group. Livers from female rats of all groups (including control) sacrificed after 28 days of treatment exhibited focal necrosis. This finding did not exhibit a dose response. This finding has been seen in other dermal studies and has been attributed to trauma and/or ischemia to the liver resulting from the wrapping and manipulation of the animals. Liver necrosis was not evident in any of the satellite
recovery animals. This finding was not considered treatment related. The treated skin of most animals revealed variable amounts of thickening of the epidermis due to acanthosis and hyperkeratosis, sebaceous gland hyperplasia and focal dermal inflammation. These changes occurred in all groups including control. However the severity of these changes tended to be increased in the male treated group rats and in the females of the 300 and 1000 mg/kg groups, suggesting a mild irritating effect of the test material. Following recovery these findings were less severe.
The test substance exhibited no evidence of systemic toxicity via the dermal route under the conditions of this study when 5 Sprague Dawley CD rats/sex were exposed to the calcium sulfonate read across substance (CAS 68783 -96 -0) over a period of 28 days. A NOAEL of 1000 mg/kg was established for this study. Under the conditions of this study, dermal application of this test material resulted in no signs of overt systemic toxicity.
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