Voglio sapere a riguardo di…

Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Rules and Regulations ethanediylbisw-hydroxy-, monosodium salt follows.

khammond on DSKJM1Z7X2PROD with RULES

A. Toxicological Profile EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by Polyoxy-1,2-ethanediyl, a, a-43-sulfophenylazophenyliminodi2,1-ethanediylbisw-hydroxy-, monosodium salt as well as the noobserved-adverse-effect-level NOAEL
and the lowest-observed-adverse-effectlevel LOAEL from the toxicity studies are discussed in this unit.
In acute studies, exposure to Polyoxy-1,2-ethanediyl, a, a-4-3sulfophenylazophenyliminodi-2,1ethanediylbisw-hydroxy-, monosodium salt resulted in no observable or minimal toxicity. The acute oral median lethal dose LD50 in rats is >2,000 mg/kg. Minimal dermal irritation was observed in an acute dermal study with rabbits. No indications of sensitization have been observed in local lymph node assay.
Two reverse mutation assays OECD
471, a mouse lymphoma assay OECD
476 and an in vitro micronucleus test OECD 487 found Polyoxy-1,2ethanediyl, a, a-4-3sulfophenylazophenyliminodi-2,1ethanediylbisw-hydroxy-, monosodium salt to not be mutagenic.
In a combined repeat dose developmental/reproduction study OECD 422, there were no adverse effects from oral administration of Polyoxy-1,2-ethanediyl, a, a-4-3sulfophenylazophenyliminodi-2,1ethanediylbisw-hydroxy-, monosodium salt up to 1000 mg/kg/day on any parameter measured, including gonadal function, mating performance, conception, development of the conceptus or parturition. The NOAEL
for these parameters was 1000 mg/kg/
day for males and females. The NOAEL
for reproductive performance and fetal/
developmental toxicity was also considered to be 1,000 mg/kg/day.
B. Toxicological Points of Departure/
Levels of Concern Based on available studies provided for Polyoxy-1,2-ethanediyl, a, a-43-sulfophenylazophenyliminodi2,1-ethanediylbisw-hydroxy-, monosodium salt, no toxicological
VerDate Sep<11>2014

16:22 May 07, 2021

Jkt 253001

endpoint of concern was identified, and a quantitative risk assessment is not required for this compound.
C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to Polyoxy-1,2-ethanediyl, a, a-4-3sulfophenylazophenyliminodi-2,1ethanediylbisw-hydroxy-, monosodium salt, EPA considered exposure under the proposed exemption from the requirement of a tolerance.
EPA assessed dietary exposures from Polyoxy-1,2-ethanediyl, a, a-4-3sulfophenylazophenyliminodi-2,1ethanediylbisw-hydroxy-, monosodium salt in food as follows:
Dietary exposure food and drinking water to Polyoxy-1,2-ethanediyl, a, a4-3sulfophenylazophenyliminodi-2,1ethanediylbisw-hydroxy-, monosodium salt is not expected to occur due to its intended use as a colorant for seed treatment. Seed treatment formulas containing Polyoxy1,2-ethanediyl, a, a-4-3sulfophenylazophenyliminodi-2,1ethanediylbisw-hydroxy-, monosodium salt will be applied directly to seeds and if released into the environment, the colorant would not be taken up by the germinating seedling and translocated within the plant vascular system to result in crop residues and dietary exposures.
2. Dietary exposure from drinking water. Since a hazard endpoint of concern was not identified for the acute and chronic dietary assessment, a quantitative dietary exposure risk assessment for drinking water was not conducted.
3. From non-dietary exposure. The term residential exposure is used in this document to refer to nonoccupational, non-dietary exposure e.g., textiles clothing and diapers, carpets, swimming pools, and hard surface disinfection on walls, floors, tables.
Polyoxy-1,2-ethanediyl, a, a-43-sulfophenylazophenyliminodi2,1-ethanediylbisw-hydroxy-, monosodium salt may be used in pesticide products and non-pesticide products used in and around the home that would have residential exposures.
However, because no toxicological endpoint of concern was identified, a quantitative residential exposure assessment for Polyoxy-1,2-ethanediyl, a, a-4-3sulfophenylazophenyliminodi-2,1ethanediylbisw-hydroxy-, monosodium salt was not conducted.

PO 00000

Frm 00035

Fmt 4700

Sfmt 4700

24733

4. Cumulative effects from substances with a common mechanism of toxicity.
Section 408b2Dv of FFDCA
requires that, when considering whether to establish, modify, or revoke a tolerance or exemption, the Agency consider available information concerning the cumulative effects of a particular pesticides residues and other substances that have a common mechanism of toxicity. EPA has not found Polyoxy-1,2-ethanediyl, a, a4-3sulfophenylazophenyliminodi-2,1ethanediylbisw-hydroxy-, monosodium salt to share a common mechanism of toxicity with any other substances, and Polyoxy-1,2ethanediyl, a, a-4-3sulfophenylazophenyliminodi-2,1ethanediylbisw-hydroxy-, monosodium salt does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has assumed that polyoxy-1,2-ethanediyl, a, a-43-sulfophenylazophenyliminodi2,1-ethanediylbisw-hydroxy-, monosodium salt does not have a common mechanism of toxicity with other substances. For information regarding EPAs efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPAs website at http
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children Based on the lack of threshold effects, EPA has not identified any toxicological endpoints of concern and is conducting a qualitative assessment of polyoxy-1,2ethanediyl, a, a-4-3sulfophenylazophenyliminodi-2,1ethanediylbisw-hydroxy-, monosodium salt. That qualitative assessment does not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children. Based on an assessment of polyoxy-1,2-ethanediyl, a, a-4-3sulfophenylazophenyliminodi-2,1ethanediylbisw-hydroxy-, monosodium salt, EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children.
E. Aggregate Risks and Determination of Safety Taking into consideration all available information on polyoxy-1,2ethanediyl, a, a-4-3sulfophenylazophenyliminodi-2,1ethanediylbisw-hydroxy-, monosodium salt when used as an inert
E:FRFM10MYR1.SGM

10MYR1