Registration Dossier
Registration Dossier
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EC number: 239-816-9 | CAS number: 15721-78-5
Endpoint summary
Administrative data
Description of key information
Additional information
Biodegradation in water: Screening test
Key study:
In a study conducted according to OECD 301B (conducted to GLP), bis(4-(1,1,3,3-tetramethylbutyl) phenyl) amine attained 20% degradation after 28 days and therefore cannot be considered to be readily biodegradable under the strict conditions of the OECD Guideline (Harlan Laboratories, 2012). Bis(4-(1,1,3,3-tetramethylbutyl) phenyl) amine achieved 16% biodegradation by day 8, and reached 20% by day 14.
According to OECD TG 301, a substance can be considered Inherently Biodegradable where there is unequivocal evidence of biodegradation (primary or ultimate) in any test of biodegradability. According to the Introduction to the OECD Guidelines for Testing of Chemicals (Section 3) Part 1: Principles and Strategies Related to the Testing of Degradation of Organic Chemicals (July, 2003) Inherent Biodegradation rates above 20% may be regarded as evidence of inherent, primary biodegradability, whereas Inherent Biodegradation rates >70% may be regarded as evidence of inherent, ultimate biodegradability. The substances is considered a inherently biodegradable.
Supporting study:
Using The Estimation Programs Interface (EPI) SuiteTMwas developed by the US Environmental Protection Agency's Office of Pollution Prevention and Toxics and Syracuse Research Corporation (SRC), the ready biodegradation of bis(4-(1,1,3,3-tetramethylbutyl) phenyl) amine is determined as not readily biodegradable (EPIWIN, 2012).
Biodegradation in water and sediment
Based on the use pattern of bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine, intentional releases into the sediment compartment are not expected. In accordance with Column 2 of Annex IX of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation, if direct and indirect exposure of sediment is unlikely, a biodegradation in soil study does not need to be conducted, therefore the endpoint is being waived.
According to the screening study, bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is considered inherently biodegradable (Harlan Laboratories, 2012).
Biodegradation in soil
Based on the use pattern of bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine, intentional releases into the soil compartment are not expected. In accordance with Column 2 of Annex IX of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation, if direct and indirect exposure of soil is unlikely, a biodegradation in soil study does not need to be conducted, therefore the endpoint is being waived.
According to the screening study, bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is considered inherently biodegradable (Harlan Laboratories, 2012).
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