Formaldehyde, oligomeric reaction products with phenol

Endpoint summary

Description of key information

Hydrolysis:

In accordance with column 2 of Annex VIII of the REACH regulation, testing for this endpoint is scientifically not necessary and does not need to be conducted since the test chemical is readily biodegradable.

Biodegradation in water

Study was conducted to determine biodegradation rate of test chemical in water. The percent degradation of test chemical was determined by using industrial waste water samples of test chemical and parameter used was biological oxygen demand (BOD). Morethan 60 % degradation was observed in 10 days of indiluted samples and 80% degradation observed in 10 days of diluted samples.

Biodegradation in water and sediment:

The study does not need to be conducted because the substance is readily biodegradable.

Biodegradation in soil:

The study does not need to be conducted because the substance is readily biodegradable.

Bioaccumulation:

BCFBAF Program (v3.00) model of EPI suite used to estimate bioconcentration dactor of test chemical. BCF of test chemical was predicted to be 8.142 L/kg wet-wt at 25°C.

Adsorption / desorption:

Study was conducted to determine adsorption coefficient of test chemical. The Adsorption Coefficient of test chemical was determined as per the HPLC method (OECD Guideline-121). The Log Koc value was determined to be 2.804± 0.001 at 25°C.

Additional information

Hydrolysis:

In accordance with column 2 of Annex VIII of the REACH regulation, testing for this endpoint is scientifically not necessary and does not need to be conducted since the test chemical is readily biodegradable.

Biodegradation in water

Various experimental studies of the test chemical were reviewed for the biodegradation end point which are summarized as below:

 

In an experimental key study from peer reviewed journal, biodegradation experiment was conducted for determining the biodegradability of test chemical. The study was performed according to guideline ISO DIS 9408 (Ultimate Aerobic Biodegradability - Method by Determining the Oxygen Demand in a Closed Respirometer) under aerobic conditions. The standard stock solutions of test chemical were prepared in distilled water according to Standard Methods (APHAAWWA-WEF, 1992). Settled municipal waste water was used as a test inoculum of 1mL concentration for the study. The percent degradation of test chemical was determined by using industrial waste water samples of test chemical and parameter used was biological oxygen demand. Morethan 60 % degradation was observed in 18 days of undiluted samples and 80% degradation observed in 10 days of diluted samples. On the basis of this percent degradability value, it is concluded that test chemical is readily biodegradable in nature.

 

In another study, the test chemical was tested to determine biodegradation rate by using two different inoculums of mixed microbial system. The test chemical was synthesized by using 14C-ring-labelled phenol and formaldehyde and parameter used to check biodegradation was labeled CO2 evolution. Fresh mixed microbial systems were used in the study which was prepared by using soils, manures, decaying plastics, and garbage. Activated and anaerobic sludges were obtained from the Limestone-Meadowbrook and Ley Creek Wastewater treatment Plants, Onondaga County, N.Y., and from the pulp sludge from a paper mill, respectively. The initial concentration of test chemical was 0.0027µCi used in the study. LS 100C-liquid scintillation counter were used to detect radioactivity of test chemical in a solution containing 5.0 g of PPO (2,5-diphenyloxazole), 0.4g of POPOP [1-4-bis-(5-phenyloxazolyl)-benzene], 6.5 ml of monoethanolamine, 500 ml of toluene, and methanol to 1 liter. The test chemical was put in 125 mL flask at concentration 0.045µCi with two different inoculums in separate flasks for 11 weeks and 5 weeks respectively at pH 7. Sterile control was used for correction for quench. By both the inoculums percent biodegradability was in the range of 0-0.15 %.

 

Based on the result of study which was performed according to standard ISO test guideline, test chemical is considered to be readily biodegradable in nature.

Biodegradation in water and sediment:

The study does not need to be conducted because the substance is readily biodegradable.

Biodegradation in soil:

The study does not need to be conducted because the substance is readily biodegradable.

Bioaccumulation:

Following different studies includes estimated study for the target chemical and experimental study for read-across analogues which is extracted by using mechanistic approach and functionally and structurally similar to the target chemical to observe the bioconcentration factor of test chemical.

Using BCFBAF Program (v3.00) model of EPI suite, bioconcentration factor (BCF) for test chemical was estimated to be 8.142 L/kg wet-wt at 25°c which does not exceed the bioconcentration threshold of 2000. Therefore it is concluded that test chemical is non-bioaccumulative in food chain.

Using Bio-concentration Factor (v12.1.0.50374) module, bio-concentration Factor of the test chemical was estimated to be 10.5, 10.0, 7.09, 1.81 and approx. 1 at pH range 0-8, 9, 10, 11 and 12-14, respectively which does not exceed the bioconcentration threshold of 2000. Therefore it is concluded that test chemical is non-bioaccumulative in food chain.

Test was conducted to determine bioconcentration factor of test chemical. Study was carrried out for 28 days. Lepomis macrochirus of 0.37-0.94 g of weight and 25-32 mm of length was used as test organism. Test organisms were exposed to 0.01 mg/l concentration of test chemical to evaluate bioconcentration factor. Oxygen supply by high flow rate and therefore no additional ventilation required. Test vessel of 40x20x25 cm was used to perfom experiment. Test organisms were acclimitized for 30 days period of time and fed with dry food. The BCF of test chemical was determined to be 150 dimensionless, which does not exceed the bioconcentration threshold of 2000. Therefore it is concluded that test chemical is non-bioaccumulative in food chain.

Test was conducted to determine bioconcentration factor (BCF) of test chemical. The BCF of test chemical was determined to be 35 dimensionless, which does not exceed the bioconcentration threshold of 2000. Therefore it is concluded that test chemical is non-bioaccumulative in food chain.

Based on the above BCF values, it is concluded that test chemical is non-bioaccumulative in food chain.

Adsorption / desorption:

The adsorption coefficient i. e Koc in soil and in sewage sludge of test chemical was determined by the Reverse Phase High Performance Liquid Chromatographic method according to OECD Guideline No. 121 for testing of Chemicals. The solutions of the test substance and reference substances were prepared in appropriate solvents.A test item solution was prepared by accurately weighing 4 mg of test chemical and diluted with Acetonitrile up to 10 ml. Thus, the test solution concentration was 400 mg/l. The pH of test substance was 4.6.Each of the reference substance and test substance were analysed by HPLC at 210 nm. After equilibration of the HPLC system, Urea was injected first, the reference substances were injected in duplicate, followed by the test chemical solution in duplicate. Reference substances were injected again after test sample, no change in retention time of reference substances was observed. Retention time tR were measured, averaged and the decimal logarithms of the capacity factors k were calculated. The graph was plotted between log Koc versus log k(Annex - 2).The linear regression parameter of the relationship log Koc vs log k were also calculated from the data obtained with calibration samples and therewith, log Koc of the test substance was determined from its measured capacity factor. The reference substances were chosen according to estimated Koc range of the test substance and generalized calibration graph was prepared.The reference substances were Acetanilide, 4-chloroaniline, 4-methylaniline(p-Tolouidine), N-methylaniline, p-toluamide, Aniline, 2,5-Dichloroaniline, 4-nitrophenol, 2 - nitrophenol, 2-nitrobenzamide, 3-nitrobenzamide, Nitrobenzene, 4-Nitrobenzamide, 1-naphthylamine, 1-naphtol, Direct Red 81, Benzoic acid methylester, Carbendazim, Benzoic acid phenylester, Xylene, Ethylbenzene, Toluene, Naphthalene, 1,2,3-trichlorobenzene, Pentachlorophenol, Phenol, N,N-dimethylbenzamide, 3,5-dinitrobenzamide, Nmethylbenzamide, Benzamide, phenanthrene, DDT having Koc value ranging from 1.25 to 5.63.The Log Koc value of test chemical was determined to be 2.804 ± 0.001 at 25°C. This log Koc value indicates that the test chemical has a moderate sorption to soil and sediment and therefore have slow migration potential to ground water.