Registration Dossier
Registration Dossier
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EC number: 251-974-0 | CAS number: 34375-28-5
Endpoint summary
Administrative data
Description of key information
Hydrolysis
Aqueous hydrolysis of test chemical 2-(hydroxymethylamino)ethanol (CAS no. 34375 -28 -5) was carried out for 30 days at pH 5, 7 and 9, respectively (HPV Chemical Challenge Program, 2016). Since radioactively labeled material was not available for the study, the 95% grade compound was used and chemical analysis was used to identify the breakdown products. The initial amount of test material dissolved in the buffers was 250 µg/ml. The buffers were autoclaved after preparation and before the test substance was added. Efforts were made to maintain sterility. For the duration of the study, the solutions were maintained in darkness in a water bath adjusted to 25°C. The temperature of the bath was recorded once daily, with an average of 25°C, ranging from 24.9 to 25.1°C. The solutions were sampled for immediate chromatographic analysis at intervals of 0, 1, 3, 7, 14, 21 and 30 days. Samples from each time point were also placed in the freezer for further analysis. Liquid chromatographic analysis of the fresh samples using post-column detection allowed quantitation of primary amines. There was immediate, or nearly immediate hydrolysis of Troysan at pH 5.0, 7.0 and 9.0 at 25°C. The hydrolysis of Troysan 174 to formaldehyde and ethanolamine was too rapid to be quantified. The recovery of 2 degradation substances together after 30 days (calculated as a percentage of the initial, using Troysan 174 dissolved in water as the standard) averaged 91.5% at pH 5, 97.5% at pH 7 and 97.1% at pH 9, respectively. Formaldehyde and ethanolamine was the breakdown product of the test chemical 2 -(hydroxymethylamino)ethanol.
Additional information
Hydrolysis
Aqueous hydrolysis of test chemical 2-(hydroxymethylamino)ethanol (CAS no. 34375 -28 -5) was carried out for 30 days at pH 5, 7 and 9, respectively (HPV Chemical Challenge Program, 2016). Since radioactively labeled material was not available for the study, the 95% grade compound was used and chemical analysis was used to identify the breakdown products. The initial amount of test material dissolved in the buffers was 250 µg/ml. The buffers were autoclaved after preparation and before the test substance was added. Efforts were made to maintain sterility. For the duration of the study, the solutions were maintained in darkness in a water bath adjusted to 25°C. The temperature of the bath was recorded once daily, with an average of 25°C, ranging from 24.9 to 25.1°C. The solutions were sampled for immediate chromatographic analysis at intervals of 0, 1, 3, 7, 14, 21 and 30 days. Samples from each time point were also placed in the freezer for further analysis. Liquid chromatographic analysis of the fresh samples using post-column detection allowed quantitation of primary amines. There was immediate, or nearly immediate hydrolysis of Troysan at pH 5.0, 7.0 and 9.0 at 25°C. The hydrolysis of Troysan 174 to formaldehyde and ethanolamine was too rapid to be quantified. The recovery of 2 degradation substances together after 30 days (calculated as a percentage of the initial, using Troysan 174 dissolved in water as the standard) averaged 91.5% at pH 5, 97.5% at pH 7 and 97.1% at pH 9, respectively. Formaldehyde and ethanolamine was the breakdown product of the test chemical 2 -(hydroxymethylamino)ethanol.
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