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ASTM F1313-90(1999)

(Specification)

Standard Specification for Volatile N-Nitrosamine Levels in Rubber Nipples on Pacifiers

Standard Specification for Volatile N-Nitrosamine Levels in Rubber Nipples on Pacifiers

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 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 problems 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.

General Information

Status
Historical
Publication Date
09-Sep-1999
ICS
67.250 - Materials and articles in contact with foodstuffs
Technical Committee
F15 - Consumer Products
Drafting Committee
F15.22 - Toy Safety
Current Stage
Ref Project

Relations

Replaced By
ASTM F1313-90(2005) - Standard Specification for Volatile N-Nitrosamine Levels in Rubber Nipples on Pacifiers
Effective Date
01-Sep-2005
Referred By
ASTM F963-17 - Standard Consumer Safety Specification for Toy Safety
Effective Date
10-Sep-1999

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ASTM F1313-90(1999) - Standard Specification for Volatile N-Nitrosamine Levels in Rubber Nipples on PacifiersASTM F1313-90(1999) - Standard Specification for Volatile N-Nitrosamine Levels in Rubber Nipples on Pacifiers
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ASTM F1313-90(1999) - Standard Specification for Volatile N-Nitrosamine Levels in Rubber Nipples on Pacifiers
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F 1313 – 90 (Reapproved 1999)
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 (e) 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,
maximum level of allowed nitrosamines in rubber nipples and
3.2.6 N-nitrosopyrrolidine,
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
standard. The values given in parentheses are for information
4. Test Method
only.
4.1 Determine nitrosamine levels by using either the meth-
1.5 The following precautionary statement pertains only to
ylenechlorideextractionmethoddescribedinthecollaborative
the test method portions, Sections 5, andAppendix X4 of this
study conducted by the National Center for Toxicological
specification. This standard does not purport to address all of
2 2
Research or the Food and Drug Administration method.
the safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
5. Acceptable Level
priate safety and health practices and determine the applica-
5.1 A test sample of nipples, drawn from a standard pro-
bilityofregulatorylimitationspriortouse.Specifichazardsare
duction lot, shall not contain more than 10 ppb (in each of 3
given in Appendix X2.
aliquots) of any one nitrosamine. In addition, the total nitro-
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—a normal production run or, in the case of
compliance in accordance with the methodology prescribed by
imports, a shipment of items produced in the same time frame.
the test procedure utilized. Records of all testing shall be
2.1.2 nitrosamines—chemically active compounds princi-
retained for a period of up to three years.
pally formed by the reaction of amines with oxides of nitrogen
present in the environment.
6. Report
3. Significance and Use 6.1 Report the following information:
6.1.1 Lot number,
3.1 This specification is intended for use in reducing the
6.1.2 Date samples,
normal exposure to nitrosamines.
6.1.3 Date tested,
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 onToy
2
Safety. Available from the Superintendent of Documents, U.S. Government Printing
Current edition approved Aug. 31, 1990. Published October 1990. Office, North Capitol and H Streets, NW, Washington, DC 20401.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F 1313
APPENDIXES
(Nonmandatory Information)
X1. BACKGROUND
X1.1 This specification provides the rationale for the conclusively providing evidence of reproducibility among
drafting of a voluntary product standard establishing accept- laboratories.
ablelevelsandtestingproceduresfornitrosaminescontainedin
X1.5 The Consumer Product Safety Commission uses the
children’s rubber pacifiers.
NCTR method in analyzing pacifiers for nitrosamine content
3
X1.2 Some nitrosamines are known to be potent animal under its enforcement policy. The FDA utilizes the FDA
4
carcinogensandaresuspectedhumancarcinogens.In1981,the 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 methods give essentially the
vulcanization of the rubber or are unintentional trace sub- same results in their laboratories.
stances present in stabilizers used in the manufacturing pro-
X1.6 The te
...

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