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PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

A study was performed to assess the ready biodegradability of the test item in an aerobic aqueous medium. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (1992) No. 301B, "Ready Biodegradability; CO2Evolution Test" referenced as Method C.4-C of Commission Regulation (EC) No. 440/2008 and US EPA Fate, Transport, and Transformation Test Guidelines OCSPP 835.3110 (Paragraph (m)).

The test item attained 1% biodegradation after 28 days and therefore cannot be considered to be readily biodegradable under the strict terms and conditions of OECD Guideline No. 301B.

 

Care should be taken in the interpretation of the results due to the inhibitory nature of the test item to the activated sewage sludge micro-organisms used in the study. It should also be noted that the test substance is a UVCB containing multiple carbon chain components and as a consequence current biodegradation tests may not be appropriate.

 

A Partition Coefficient (n-octanol/water) study was conducted in accordance with GLP standards and OECD 117 (HPLC Method) Test Guidelines. The OECD117 study concluded that the Partition Coefficient (n-octanol/water) was

less than 2.00 to greater than 3.16 x 106, log10 Pow range <0.30 to >6.50. This wide range of values was considered to be a result of the registered substance being a UVCB and also the fact that the OECD 117 test is qualitative rather than quantitative method.

Using the data contained within the Report (Table 19) Ten HPLC Peaks were determined ranging from 0.1 to 44.29% of the peak area. This data has been used to determine a weighted average Log10 Pow = 2.537 (10 components identified in Envigo study number VP81MK) Regulatory Endpoint.

 

The effect of the test item on the growth of Pseudokirchneriella subcapitata has been investigated over a 72-Hour period and gave the following results:

a)           72h-EL50 (Growth rate) (mg/l loading rate WAF): 1.1 (Acute Regulatory endpoint, used for PNEC derivation) As described in ECHA guidance TableR.10 -4 an assessment factor of 1000 has been applied. The No Observed Effect Loading rate was 0.125 mg/L loading rate WAF.

b)           NOEL (Growth rate) (mg/l loading rate WAF): 0.125 mg/l (Chronic Regulatory endpoint)

c)           LOEL (Growth rate) (mg/L loading rate WAF): 0.25

 

A Bacterial Reverse Mutation Assay and an in vitro mammalian chromosomal aberration assay were carried out on 1,3-Benzenedimethanamine, reaction

products with glycidyl tolyl ether in accordance with OECD guidelines 471 and 473 respectively.

 

The bacterial reverse mutation assay was concluded to be negative without conducting a confirmatory (independent repeat) assay because the results

were clearly negative; hence, no further testing was warranted. The in vitro mammalian chromosomal aberration assay carried out on 1,3-Benzenedimethanamine, reaction products with glycidyl tolyl ether and was concluded to be negative for the induction of structural chromosomal aberrations and positive for

the induction of numerical chromosomal aberrations in the non-activated and S9-activated test systems in the in vitro mammalian chromosomal aberration assay using CHO cells.

 

For purposes outside of the EU and as a result of the positive results (numerical aberrations) within the chromosome aberration test the registered

substance, 1,3 -Benzenedimethanamine, reaction products with glycidyl tolyl ether, was further tested for its clastogenic activity and/or disruption of the

mitotic apparatus by detecting micronuclei in polychromatic erythrocyte (PCE) cells in rat bone marrow.

 

Under the conditions of this micronucleous study, the administration of 1,3-Benzenedimethanamine, reaction products with glycidyl tolyl ether at doses up to and including a dose of 125, 250, and 500 mg/kg/day was concluded to be negative in the Micronucleus assay.

 

No evidence of specific organ toxicity.