ABSTRACT
The existing information supports the use of this material as described in this safety assessment. 2-Methyl-4-phenylbutyraldehyde was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog ß-methyl-benzenepentanal (CAS # 55066-49-4) show that 2-methyl-4-phenylbutyraldehyde is not expected to be genotoxic and provide a calculated Margin of Exposure (MOE) >100 for the repeated dose toxicity endpoint. Data on read-across analog phenylacetaldehyde (CAS # 122-78-1) provide a calculated MOE >100 for the reproductive toxicity endpoint. Data show that there are no safety concerns for 2-methyl-4-phenylbutyraldehyde for skin sensitization under the current declared levels of use. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 2-methyl-4-phenylbutyraldehyde is not expected to be photoirritating/photoallergenic. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to 2-methyl-4-phenylbutyraldehyde is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; 2-methyl-4-phenylbutyraldehyde was found not to be Persistent, Bioaccumulative, and Toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards, and its risk quotients, based on its current volume of use (VoU) in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.
ABSTRACT
Introduction: Primary spinal cord tumors are rare tumors that are usually heterogeneous having variable histopathological subtypes. Rapidly, growing space-occupying lesions in the spinal canal cause severe loss of function. This study aimed to analyze all adult patients diagnosed with primary spinal cord tumors and to describe their location, symptoms, histopathological types, surgical outcome, complications, recurrence in a single institution, and prognostic factors. Materials and Methods: The study was a retrospective study of 178 patients with spinal tumor who underwent surgical intervention at the department of neurosurgery at a tertiary care institute from 2014 to 2021. Patient demographic characteristics, symptoms, radiological features, spinal level of tumor, spinal compartment, preoperative and postoperative McCormick grade, and complications were recorded, and a comparison of outcomes after surgical intervention was done. Results: In our study, 97 patients were males and the rest of the 81 patients were females. The mean age at the time of surgery was 43.5 years. The thoracic region of the spinal canal was the most involved with 67 (37.64%) cases, whereas intradural extramedullary was the most common (65.73%). Schwannoma was the most common histopathological subtype (46.06%). Total excision was achieved in 154 cases. A total of 37 patients were in Grades 4 and 5 of modified McCormick's grade preoperatively. However, postoperatively, there were only 17 patients in this group. Two patients with cervical intramedullary tumor expired in the postoperative period. Conclusion: Early surgical intervention with sound microneurosurgical skills gives good outcomes independent of the type and location of tumor. Better outcomes are seen in extradural tumors, early surgical intervention, tumors better amenable to total resection, and in patients with better preoperative neurological status.