Standard Specification for Volatile N-Nitrosamine Levels in Rubber Nipples on Pacifiers (Withdrawn 2020)

ABSTRACT
This specification applies to the nitrosamine content of rubber used in the manufacture of nipples for infant pacifiers. This specification is intended for use in reducing the normal exposure to nitrosamines. Methylene chloride extraction method shall be used to determine the nitrosamine levels.
SIGNIFICANCE AND USE
This specification is intended for use in reducing the normal exposure to nitrosamines.
This specification refers only by way of example to the eight volatile N-nitrosamines identified below:  
N-nitrosodimethylamine,
N-nitrosodiethylamine,
N-nitrosodibutylamine,
N-nitrosomorpholine,
N-nitrosopiperidine,
N-nitrosopyrrolidine,
N-ethylphenylnitrosamine.
SCOPE
1.1 This specification applies to the nitrosamine content of rubber used in the manufacture of nipples for infant pacifiers.
1.2 This specification does not apply to plastic nipples (on pacifiers).  
1.3 The purpose of this specification is to establish a maximum level of allowed nitrosamines in rubber nipples and to outline a uniform testing method to determine such level.
1.4 The values stated in SI units are to be regarded as standard. The values given in parentheses are for information only.
1.5 The following precautionary statement pertains only to the test method portions, Sections 5, and Appendix X4 of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Specific hazards are given in Appendix X2.
WITHDRAWN RATIONALE
This specification applies to the nitrosamine content of rubber used in the manufacture of nipples for infant pacifiers.
Formerly under the jurisdiction of Committee F15 on Consumer Products, this specification was withdrawn in January 2020 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

General Information

Status
Withdrawn
Publication Date
31-Jan-2011
Withdrawal Date
12-Jan-2020
Technical Committee
Drafting Committee
Current Stage
Ref Project

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ASTM F1313-90(2011) - Standard Specification for Volatile N-Nitrosamine Levels in Rubber Nipples on Pacifiers (Withdrawn 2020)
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F1313 −90 (Reapproved 2011)
Standard Specification for
VolatileN-Nitrosamine Levels in Rubber Nipples on
1
Pacifiers
This standard is issued under the fixed designation F1313; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3.2 This specification refers only by way of example to the
eight volatile N-nitrosamines identified below:
1.1 This specification applies to the nitrosamine content of
3.2.1 N-nitrosodimethylamine,
rubber used in the manufacture of nipples for infant pacifiers.
3.2.2 N-nitrosodiethylamine,
1.2 This specification does not apply to plastic nipples (on
3.2.3 N-nitrosodibutylamine,
pacifiers).
3.2.4 N-nitrosomorpholine,
1.3 The purpose of this specification is to establish a 3.2.5 N-nitrosopiperidine,
3.2.6 N-nitrosopyrrolidine,
maximum level of allowed nitrosamines in rubber nipples and
to outline a uniform testing method to determine such level. 3.2.7 N-ethylphenylnitrosamine.
1.4 The values stated in SI units are to be regarded as
4. Test Method
standard. The values given in parentheses are for information
4.1 Determine nitrosamine levels by using either the meth-
only.
ylenechlorideextractionmethoddescribedinthecollaborative
1.5 The following precautionary statement pertains only to
study conducted by the National Center for Toxicological
the test method portions, Sections 5, and Appendix X4 of this
2 2
Research or the Food and Drug Administration method.
specification. This standard does not purport to address all of
the safety concerns, if any, associated with its use. It is the
5. Acceptable Level
responsibility of the user of this standard to establish appro-
5.1 A test sample of nipples, drawn from a standard pro-
priate safety and health practices and determine the applica-
duction lot, shall not contain more than 10 ppb (in each of 3
bilityofregulatorylimitationspriortouse.Specifichazardsare
aliquots) of any one nitrosamine. In addition, the total nitro-
given in Appendix X2.
samines of the sample shall not exceed 20 ppb.
2. Terminology
5.2 Eachmanufacturerordistributoroftheproductshalltest
2.1 Definitions: the product in such a manner and at such intervals to ensure
2.1.1 lot—normal production run or, in the case of imports, compliance in accordance with the methodology prescribed by
a shipment of items produced in the same time frame. the test procedure utilized. Records of all testing shall be
retained for a period of up to three years.
2.1.2 nitrosamines—chemically active compounds princi-
pally formed by the reaction of amines with oxides of nitrogen
6. Report
present in the environment.
6.1 Report the following information:
3. Significance and Use
6.1.1 Lot number,
6.1.2 Date samples,
3.1 This specification is intended for use in reducing the
6.1.3 Date tested,
normal exposure to nitrosamines.
6.1.4 Individual nitrosamine content, and
6.1.5 Total nitrosamine content.
1
This specification is under the jurisdiction of ASTM Committee F15 on
Consumer Products and is the direct responsibility of Subcommittee F15.22 on Toy
Safety.
2
CurrenteditionapprovedFeb.1,2011.PublishedJune2011.Originallyapproved AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
in 1990. Last previous edition approved in 2005 as F1313–90 (2005). DOI: 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
10.1520/F1313-90R11. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F1313−90 (2011)
APPENDIXES
(Nonmandatory Information)
X1. BACKGROUND
X1.1 This specification provides the rationale for the draft- ites were sent to each laboratory for analysis and tally,
ing of a voluntary product standard establishing acceptable conclusively providing evidence of reproducibility among
levels and testing procedures for nitrosamines contained in laboratories.
children’s rubber pacifiers.
X1.5 The Consumer Product Safety Commission uses the
NCTR method in analyzing pacifiers for nitrosamine content
X1.2 Some nitrosamines are known to be potent animal
3
under its enforcement policy. The FDA utilizes the FDA
carcinogensandaresuspectedhumancarcinogens.In1981,the
4
method in its Compliance Policy Guide, 7117.15. The CPSC
West German Government enacted regulations limiting the
and NCTR staffs characterize the NCTR method as cheaper,
amount of preformed nitrosamine in rubber pacifiers. Nitro-
faster, and more reproducible, although both the NCTR and
samines are formed from amines used as accelerators during
FDAhave affirmed that their two metho
...

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