2-(hydroxymethylamino)ethanol

Endpoint summary

Description of key information

Short-term toxicity to fish

Rainbow trout were exposed to a five test concentrations of Troysan 174 and a negative (well water) control for 96 h. Two replicate test chambers were maintained in each treatment and control group, with 10 fish in each test chamber. Nominal test concentrations selected were 13.0, 21.6, 36.0, 60.0, and 100 mg of Troysan 174/L which is based upon the results of acute range finding toxicity tests. Observations of mortality and other clinical signs of toxicity were made at 2, 24, 48, 72, and 96 hours. The 96-hour LC50 value for rainbow trout exposed to Troysan 174 was >100 mg/L. The 96-hour no observed effect concentration was 100 mg/L, as determined by visual examination of the toxicity data. 

Short term toxicity to aquatic invertebrates

The test was performed in daphnia magna from High Production Volume Information System (HPVIS) EPA 1992 .Daphnia magna were exposed to Nominal concentrations (mg/L): 0, 13.0, 21.6, 36.0, 60.0 and 100 mg/L and measured concentrations (mg/L): 24 hours: 0.3, 10.0, 18.2, 34.3, 60.5, 107.5 mg/L.48 hours: 0, 6.7, 9.9, 37.1, 48.1, 72.5 mg/L of Troysan 174 and a negative (well water) control for 48h.

Daily observations of mortality and other signs of toxicity were recorded. There was no mortality, immobilization or signs of toxicity observed in the 13.0 mg/L treatment group. All daphnids in that group appeared healthy and normal throughout the test. While there were no mortalities or other signs of toxicity during the first 24 hours of exposure in the 21.6 and 36.0 mg/l treatment groups, by 48 hours mortality in those two groups was 5% and 95% respectively. At 60.0 mg/L there was 65% mortality within the first 24 hours, and 100% mortality by 48 hours. At 100 mg/L the highest concentration tested, 100% mortality occurred within 24 hours of test initiation. The 48 hour EC50 value for daphnids exposed to Troysan 174 was 27.9 mg/L. The 95% confidence limits for the EC50 value were 21.6 and 36.0 mg/L. The 48hour No Observed Effect Concentration was 13.0 mg/L, as determined by visual observation of the toxicity data. Based on the value, 2-[hydroxy(methyl)amino]ethanol (34375-28-5) was considered to be toxic to aquatic invertebrates but as it was readily biodegradable hence, 2-[hydroxy(methyl)amino]ethanol was considered to not classified as per the CLP regulations.

Toxicity to aquatic algae and cyanobacteria

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, the short term toxicity on aquatic algae and cyanobacteria was predicted for target substance 2-[hydroxy(methyl)amino]ethanol (CAS no. 34375 -28 -5). EC50 value was estimated to be 385.6 mg/l for Desmodesmus subspicatus for 72 h duration. Based on this value it can be concluded that the substance 2-[hydroxy(methyl)amino]ethanol is considered to be non-toxic to aquatic environment and can be considered to be not classified as per the CLP classification criteria.

Additional information

Short-term toxicity to fish

Four results including different experimental and predicted data from validated models for short term fish toxicity endpoint of target chemical 2-[hydroxy(methyl)amino]ethanol (Cas no. 34375-28-5) were summarized as follows:

 

First study from HPVIS database by US EPA; 2017 which indicate Rainbow trout were exposed to a five test concentrations of Troysan 174 and a negative (well water) control for 96 h. Two replicate test chambers were maintained in each treatment and control group, with 10 fish in each test chamber. Nominal test concentrations selected were 13.0, 21.6, 36.0, 60.0, and 100 mg of Troysan 174/L which is based upon the results of acute range finding toxicity tests. Observations of mortality and other clinical signs of toxicity were made at 2, 24, 48, 72, and 96 hours. The 96-hour LC50 value for rainbow trout exposed to Troysan 174 was >100 mg/L. The 96-hour no observed effect concentration was 100 mg/L, as determined by visual examination of the toxicity data. 

Above aquatic classification supported by ECOTOX database,2017 suggest In Acute fish toxicity study, the lethal concentration (LC50) was determined for test substance 2-[hydroxy(methyl)amino]ethanol with an exposure period of 96 hrs. on the basis of effects on mortality. Test organism used was Oncorhynchus mykiss in static freshwater system. The Lethal concentration to 50% of test organisms(LC50) on the basis of Mortality effect was observed to be 0.0603 mg/l and No-observable-effect-level (NOEL) was observed to be 0.0307 mg/l for exposure period of 96 hrs.

Thus based on the above value, it is concluded that the test substance 2-[hydroxy(methyl)amino]ethanol hazarous to aquatic environment,since the substance is readily biodegradable in nature it is consider that test substance 2-[hydroxy(methyl)amino]ethanol not classified as per the CLP criteria.

And Prediction is done using OECD QSAR Toolbox version 3.3 with logKow as the primary descriptor data indicate the prediction was based on the effects of the test compound on Danio rerio (previous name: Brachydanio rerio) in a static fresh water system during a 96 hour exposure. The lethal concentration (LC50) for the test compound 2-[hydroxy(methyl)amino]ethanol (CAS no. 34375-28-5) was estimated to be 312.69 mg/l on the basis of mortality effect. Thus, based on this value, test chemical compound 2-[hydroxy(methyl)amino]ethanol was considered to be non toxic to fish and thus can be not classified as per the CLP regulations.

Above all results assist by prediction using the EPI Suite ECOSAR version 1.10, the short term toxicity on fish was predicted for test substance 2-[hydroxy(methyl)amino]ethanol (CAS: 34375-28-5). On the basis of effects observed in a static freshwater system, the lethal concentration LC50 value for the substance is estimated to be 447000 mg/l for fish for 96 h duration. Based on this value, it can be concluded that the test chemical 2-[hydroxy(methyl)amino]ethanol can be considered as non toxic to fish at environmentally relevant concentrations and can be considered to be not classified as per the CLP classification criteria.

Thus all available studies for short term fish toxicity endpoint come to conclusion that the test substance 2-[hydroxy(methyl)amino]ethanol (Cas no. 34375-28-5) is expected to be non toxic to fish and thus not consider for aquatic classification.

Short term toxicity to aquatic invertebrates

Short term toxicity to aquatic invertebrates 2-[hydroxy(methyl)amino]ethanol (34375-28-5) was summaries with experimental data for target and experimental study of functional read across are summaries as follows:

The test was performed in daphnia magna from High Production Volume Information System (HPVIS) EPA 1992 .Daphnia magna were exposed to Nominal concentrations (mg/L): 0, 13.0, 21.6, 36.0, 60.0 and 100 mg/L and measured concentrations (mg/L): 24 hours: 0.3, 10.0, 18.2, 34.3, 60.5, 107.5 mg/L.48 hours: 0, 6.7, 9.9, 37.1, 48.1, 72.5 mg/L of Troysan 174 and a negative (well water) control for 48h.

Daily observations of mortality and other signs of toxicity were recorded. There was no mortality, immobilization or signs of toxicity observed in the 13.0 mg/L treatment group. All daphnids in that group appeared healthy and normal throughout the test. While there were no mortalities or other signs of toxicity during the first 24 hours of exposure in the 21.6 and 36.0 mg/l treatment groups, by 48 hours mortality in those two groups was 5% and 95% respectively. At 60.0 mg/L there was 65% mortality within the first 24 hours, and 100% mortality by 48 hours. At 100 mg/L the highest concentration tested, 100% mortality occurred within 24 hours of test initiation. The 48 hour EC50 value for daphnids exposed to Troysan 174 was 27.9 mg/L. The 95% confidence limits for the EC50 value were 21.6 and 36.0 mg/L. The 48hour No Observed Effect Concentration was 13.0 mg/L, as determined by visual observation of the toxicity data. Based on the value, 2-[hydroxy(methyl)amino]ethanol (34375-28-5) was considered to be toxic to aquatic invertebrates but as it was readily biodegradable hence, 2-[hydroxy(methyl)amino]ethanol was considered to not classified as per the CLP regulations.

Another study from Ecotox database 2017 was performed in Daphnia magna for 48 hrs with <24 hrs age. 5 daphnia magna used in fresh water media. After the experiment, the EC 50 value for 2-[hydroxy(methyl)amino]ethanol (34375-28-5) was determined to be 25.2 mg/l on the basis of intoxication. Based on the value, 2-[hydroxy(methyl)amino]ethanol (34375-28-5) was considered to be toxic to aquatic invertebrates but as it was readily biodegradable hence, 2-[hydroxy(methyl)amino]ethanol was considered to not classified as per the CLP regulations.

For functionally similar read across 1,3-Propanediol (504-63-2) study was performed accordance with the DIN 38412, Part II (Daphnia short-time test) (German Institute of Standardization, 1982) from Water. Res. Vol. 23, No.4, pp. 495--499, 1989. The test was performed in 6-24 h old daphnids were placed in each test and control vessel, i.e: 20 animals per concentration step. The test was performed in 50 ml beaker with ground-glass stoppers each with 20 ml useful capacity. After a test period of 24 h and 48 h, the number of animals in the control and test solutions that could still swim was counted. After the experiment, the EC 50 value for 1,3-Propanediol (504-63-2) was determined to be 7417 mg/l in concentration range from 6430-8555 mg/l. Based on the result, the 1,3-Propanediol (504-63-2)was considered to be non-toxic t aquatic invertebrates and can be considered to be not classified as per the CLP regulations.

Based on the experimental studies of target and study of functional read across, it was considered that 2-[hydroxy(methyl)amino]ethanol (34375-28-5) was non-toxic to aquatic invertebrates and can be considered to be not classified as per the CLP regulations.

Toxicity to aquatic algae and cyanobacteria

Various predicted data for the target chemical 2-[hydroxy(methyl)amino]ethanol(CAS No. 34375-28-5) and weight of evidence study for its read across substancewere reviewed to summarize the following information:

 

Short term toxicity on aquatic algae and cyanobacteria of target chemical2-[hydroxy(methyl)amino]ethanol(CAS No. 34375-28-5) is predicted using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances (2017). EC50 value was estimated to be 385.6 mg/l for Desmodesmus subspicatus for 72 h duration. Based on this value it can be concluded that the substance 2-[hydroxy(methyl)amino]ethanol is considered to be non-toxic to aquatic environment and can be considered to be not classified as per the CLP classification criteria.

 

In another prediction done using the EPI Suite ECOSAR version 1.10 (EPI Suite, 2017), the short term toxicity on green algae was predicted for test substance2-[hydroxy(methyl)amino]ethanol(CAS No. 34375-28-5).On the basis of effects observed in a static freshwater system, the effect concentration EC50 value for the substance is estimated to be 25761.029 mg/l for green algae for 96 h duration. Based on this value, it can be concluded that the test chemical 2-[hydroxy (methyl)amino]ethanol can be considered as non-toxic to green algae at environmentally relevant concentrations and can be considered not-classifiedas per the CLP classification criteria.

 

In a weight of evidencestudy from secondary source (OECD SIDS, 2006) of the read across chemical C.I. Pigment Black 7 (CAS no. 1333 -86 -4),short term toxicity to Selenastrum capricornutum (Green algae) study was carried out for 24 hrs. The study was performed according to ISO 8692 (Water Quality - Fresh Water Algal Growth Inhibition Test with Scenedesmus subspicatus and Selenastrum capricornutum) and NF EN 28692 Guideline. The study was based on the effects of the read across compound C.I. Pigment Black 7 on Selenastrum capricornutum (green algae) in a static fresh water system. Selenastrum capricornutum was used as a test organism. After 72 hours of exposure to C.I. Pigment Black 7, the 72 hr EC50 value was determined to be > 13,000 mg/l. Thus, based on the EC50 value, it can be concluded that the substance C.I. Pigment Black 7 can be considered as non-toxic to Selenastrum capricornutum at environmentally relevant concentrations and can be considered to be not-classified as per the CLP classification criteria.

 

For the same read across chemical C.I. Pigment Black 7 (CAS no. 1333 -86 -4), short term toxicity to Scenedesmus subspicatus (Green algae) study was carried out for 72 hrs. The study was performed according to OECD Guide-line 201 "Algae, Growth Inhibition Test". The study was based on the effects of the read across compound C.I. Pigment Black 7 (CAS no. 1333 -86 -4) on Scenedesmus subspicatus (green algae) in a static fresh water system at a temperature range of 21.4 – 24.4°C, pH 8.15 and light intensity of greater than 120 µE/m2s, respectively. Scenedesmus subspicatus (at an initial cell density of 8 × 104cells/ml) was used as a test organism. The algal stock culture was cultivated under strictly aseptic conditions within Institut Fresenius. Test chemical suspensions was prepared in ultrapure water at 6250, 630, and 63 mg per 500 ml batch. After 24 hours incubation at room temperature on a shaking machine, during which time equilibration was considered to be achieved, the suspensions were filtered through a filter paper, which had previously been thoroughly rinsed with ultrapure water. These filtered solutions were then passed through sterile membrane filters to ensure sterile conditions for the test. Test chemical concentration used for the study was 100.8, 1,008 and 10,000 mg/l, respectively (nominal concentrations). Mineral nutrient medium containing Fe complex and additional trace elements was prepared in ultrapure water. Solid sodium hydrogen carbonate was added, to give twice the concentration indicated in the OECD guideline. This solution, at pH 8.15 after equilibration with air, was sterilized by ultrafiltration through a 0.45µ membrane filter before the test. The incubation of the test and control solutions was carried out for 72 hrs. The solutions were stirred for 15 minutes in every hour with a magnetic stirrer, to ensure adequate CO2 input. The test solutions were covered with a Plexiglas lid, to maintain sterile conditions. Based on the effect on the growth rate of the test organism Scenedesmus subspicatus, the 72 hr NOEC, EC10 and EC50 value was determined to be > 10,000 mg/l. Thus, based on the EC50 value, it can be concluded that the substance C.I. Pigment Black 7can be considered as non-toxic to Scenedesmus subspicatus at environmentally relevant concentrations and can be considered to be not-classified as per the CLP classification criteria.

 

Thus, based on the overall reported results for target chemical 2 -[hydroxy(methyl)amino]ethanol (OECD QSAR toolbox version 3.3 and EPI suite, 2017) and for its read across substance (from secondary source OECD SIDS), it can be concluded that the test substance 2 -[hydroxy(methyl)amino]ethanol can be considered as non-toxic to aquatic environment and can be considered to be not classified as per the CLP classification criteria.