2

Hydrolysis (161

- 1, 835.2120)

In the 9/ 14 /11 memorandum from James Breithaupt (D357908, D378130), the conclusion for hydrolysis was that the five hydrolysis studies involved in the subject product’s application together satisfy the 835.2120/161

- 1 data requirement for Contram ST

- 1. None of the studies were completely acceptable, although there was one study (MRID 47555820) which did not address material balance or degradate identification but which was found to b e supplemental but not acceptable because of the lack of any material balance and degradate identification. The absence of either material balance or degradate identification can be a basis for outright rejection of the study and a classification of such a study as being unacceptable to satisfy the 835.2120/161

- 1 data requirement

. Environmental fate studies require a material balance of 90

- 110 % of applied radiolabeled substances and 70

- 120 % of applied non

- radiolabeled substances. Degradates at or above 10 % of applied substance require identification. However, in this case, due to the reasons identified and explained below and in the attached document, information on material balance and degradates has been determine d to be im practical to obtain for hydrolysis testing of this subject substance

. In light of information which has become available to the Agency since 9/ 14 /11 and subsequently reviewed, t he hydrolysis study (MRID 47555820) is now classified as acceptable and satisfies the hydrolysis data requirement (835.2120, 161

- 1 )

, when combined with the attached 9/20/11 “Expert Statement” signed by D F White, Supervisor of Physico

- Chemical Properties of Harlan Laboratories (formerly SafePharm Laboratories)

. The “Exp ert Opinion” is located in Appendix A. According to the attached “Expert Statement, ” material balance was not technically feasible in the subject substance’s hydrolysis testing because the extremely short half

- life of <1 day created the inability to detect any parent compound. The absence of degradate identification was based on matrix interference from the buffer compounds that prevent pH change in the solutions being tested . The buffer compounds would have absorbed the UV/Visible light from detect ors and the detected response from buffer compounds could be greater than from any degradates of Contram ST

- 1. Based on the apparent degradation pathway,
t he degradates would be morpholine and formaldehyde in the ratio of 2:1. The factors affecting

measu rement feasibility in this case, which stem from the nature of the subject substance, adequately justify not requiring the aforementioned material balance and degradate identification information in this instance.

Activated Sewage Sludge Isotherm (835.1110)

Data on activated sewage sludge isotherm are not required at this time for Contram ST

- 1, contrary to the 9/ 14 /11 memorandum. These data are not required under 40 CFR Part 161; the activated sewage sludge isotherm study is contained in proposed 40 CFR Part 158W but it is not a current data requirement under the existing data requirements regulation.

Table 1 below contains the current status of environmental fate data requirements.3

Table 1. Environmental Fate and Transport Properties of Contram

Property Value Comments/Reference Hydrolysis (835.21 2 0) Half

- life of 3.6 months in oil

based metalworking fluids (intended use) Rapid degradation in guideline and other non

- guideline studies with half

- lives of <6 seconds to 1 day. Guideline study is acceptable when combined with 9

- 20

- 11 “Expert Statement” discussed above and attached to this

memo. Non

- guideline studies provide additional informa tion

. Data requirement satisfied by MRID 47555820 . MRIDs
, 47555821, 48064802, 48064803, and 48064804 provide additional information. Leaching

- adsorption

desorption (835.1230) Koc value of 18 ml/g MRID 47555820 Satisfied Ready Biodegradability (OECD 3 01, 835.3110) Contram ST

- 1 was readily biodegradable Biodegradation reached 93 % after 28 days Satisfied MRID 47571313

Sewage Sludge Respiration Inhibition (OECD 309, 835.6800) NOAEC by 3 hours of 32 mg/l, EC50 values of 800 and 340 mg/l by 30 minutes and 3 hours EC20 of 133 mg/l for both times EC80 concentrations not reached MRID 47555828 Satisfied

Activated Sewage Sludge Isotherm (835.1110) No Not required as explained above.

If there are any question s, please contact Jim Breithaupt at 703

- 305

- 5925 or at breithaupt.james @e pa.gov

.4

Appendix A. September 20 th , 2011 Expert Opinion from Harlan Laboratories

Sign

- off Date : 09/22/11 DP Barc ode No.: D394355