[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR158.190]



[Page 97]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 158_DATA REQUIREMENTS FOR REGISTRATION--Table of Contents

 

              Subpart C_Product Chemistry Data Requirements

 

Sec.  158.190  Physical and chemical characteristics.



    (a) Table. Sections 158.50 and 158.100 through 158.102 describe how 

to use this table to determine the physical and chemical characteristics 

data requirements and the substance to be tested.



----------------------------------------------------------------------------------------------------------------

                                            All general use               Test substance

                                               patterns      ---------------------------------------- Guidelines

     Kind of data required         (b)     (requirements are                                           reference

                                  Notes   the same for every  Data to support MP  Data to support EP      No.

                                             use pattern)

----------------------------------------------------------------------------------------------------------------

Color..........................  .......  [R]...............  MP and TGAI.......  EP* and TGAI......     63-2

Physical state.................  .......  [R]...............  MP and TGAI.......  EP* and TGAI......     63-3

Odor...........................  .......  [R]...............  MP and TGAI.......  EP* and TGAI......     63-4

Melting point..................  (\1\)    [R]...............  TGAI..............  TGAI..............     63-5

Boiling point..................  (\2\)    [R]...............  TGAI..............  TGAI..............     63-6

Density, bulk density, or        .......  [R]...............  MP and TGAI.......  EP* and TGAI......     63-7

 specific gravity.

Solubility.....................  .......  [R]...............  TGAI or PAI.......  TGAI or PAI.......     63-8

Vapor pressure.................  .......  [R]...............  TGAI or PAI.......  TGAI or PAI.......     63-9

Dissociation constant..........  .......  [R]...............  TGAI or PAI.......  TGAI or PAI.......    63-10

Octanol/water partition          (\3\)    [CR]..............  PAI...............  PAI...............    63-11

 coefficient.

pH.............................  (\4\)    [CR]..............  MP and TGAI.......  EP* and TGAI......    63-12

Stability......................  .......  [R]...............  TGAI..............  TGAI..............    63-13

Oxidizing or reducing action...  (\5\)    [CR]..............  ..................  ..................  ..........

Flammability...................  (\6\)    [CR]..............  MP................  EP*...............    63-15

Explodability..................  (\7\)    [R]...............  MP................  EP*...............    63-16

Storage stability..............  .......  [R]...............  MP................  EP*...............    63-17

Viscosity......................  (\8\)    [CR]..............  MP................  EP*...............    63-18

Miscibility....................  (\9\)    [CR]..............  MP................  EP*...............    63-19

Corrosion characteristics......  .......  [R]...............  MP................  EP*...............    63-20

Dielectric breakdown voltage...  (\10\)   [CR]..............  ..................  EP*...............    63-21

Other requirements: Submittal    (\11\)   [CR]..............  MP, TGAI, PAI.....  EP*, TGAI, PAI....     64-1

 of samples.

----------------------------------------------------------------------------------------------------------------

Key: R = Required; CR = Conditionally Required; [ ] = Brackets (i.e., [R],[CR]) indicate data requirements that

  apply when an experimental use permit is being sought; MP = Manufacturing Use Product, EP* = End Use Product;

  asterisk indicates those registrants that end-use applicants (i.e., formulators) need not satisfy, if their

  active ingredient(s) is (are) purchased from a registered source; TGAI = Technical Grade of the Active

  Ingredient; PAI = Pure Active Ingredient.

(b) Notes. The following notes are referenced in column two of the table contained in paragraph (a) of this

  section.

(\1\) Required if technical chemical is a solid at room temperature.

(\2\) Required if technical chemical is a liquid at room temparature.

(\3\) Required if technical chemical is organic and non-polar.

(\4\) Required if test substance is dispersible with water.

(\5\) Required if product contains an oxidizing or reducing agent.

(\6\) Required if product contains combustible liquids.

(\7\) Required if product is potentially explosive.

(\8\) Required if product is a liquid.

(\9\) Required if product is a emulsifiable liquid and is to be diluted with petroleum solvents.

(\10\) Required if end-use product is a liquid and is to be used around electrical equipment.

(\11\) Basic manufacturers are required to provide the Agency with a sample of each TGAI used to formulate a

  product produced by an integrated system when the new TGAI is first used as a formulating ingredient in

  products registered under FIFRA. A sample of the active ingredient (PAI) suitable for use as an analytical

  standard is also required at this time. Samples of end use products produced by an integrated system must be

  submitted on a case-by-case basis.





[49 FR 42881, Oct. 24, 1984, as amended at 58 FR 34203, June 23, 1993]