ASTM E981-19

Standard Test Method for Estimating Sensory Irritancy of Airborne Chemicals

SIGNIFICANCE AND USE
3.1 This test method was developed to meet the following criteria:  
3.1.1 It provides positive recognition of sensory irritants of widely varying potencies.  
3.1.2 It is sufficiently simple to permit the testing of large numbers of materials.  
3.1.3 This test method is capable of generating concentration-response curves for purposes of compound comparison.  
3.1.4 This test method has good reproducibility.  
3.2 This test method can be used for a variety of divergent purposes, including the assessment of comparative irritancy of compounds or formulations and setting interim exposure levels for the workplace  (1, 2).2  
3.3 It has been shown that for a wide variety of chemicals and mixtures, a perfect rank order correlation exists between the decreases in respiratory rate in mice and subjective reports of sensory irritation in man (1, 3, 4, 5).  
3.4 A quantitative estimate of the sensory irritancy of a wide variety of materials can be obtained from concentration-response curves developed using this method (1, 3, 4, 6, 7, 8, 9).  
3.5 Although this test method is intended to measure sensory irritation of the nasal mucosa, the cornea is innervated by the same nerve. This animal model will, therefore, allow an estimate of the irritant potential of cosmetic ingredients or other household products to the eye, assuming that they can be aerosolized (10).  
3.6 This test method is recommended for setting interim guidelines for exposure of humans to chemicals in the workplace, to assess acute sensory irritation resulting from inadvertent spills of household products, and to assess the comparative irritancy of formulations or materials intended for a variety of uses (see Appendix X2).
FIG. 1 Typical Tracing of Normal Mouse Respiration (Top), and of a“ Moderate” Sensory Irritant Response (Bottom)  
Note 1: Taken from Ref. (3).
FIG. 2 Typical Tracing of Normal Mouse Respiration (Top), a Moderate Pulmonary Irritant Response (Center), and an Extreme Pulmonary Irr...
SCOPE
1.1 This laboratory test method provides a rapid means of determining sensory irritant potential of airborne chemicals or mixtures. It may also be used to estimate threshold limit values (TLV) for man. However, it cannot be used to evaluate the relative obnoxiousness of odors.  
1.2 This test method is intended as a supplement to, not a replacement for, chronic inhalation studies used to establish allowable human tolerance levels.  
1.3 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Specific hazard information is given in Section 6.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 31-Jan-2019
• ICS: 13.040.01 - Air quality in general
• Technical Committee: E50 - Environmental Assessment, Risk Management and Corrective Action
• Drafting Committee: E50.47 - Biological Effects and Environmental Fate

Relations

• Referred By: ASTM E1302-23 - Standard Guide for Acute Animal Toxicity Testing of Water-Miscible Metalworking Fluids
• Effective Date: 01-Feb-2019

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E981 − 19
Standard Test Method for
1
Estimating Sensory Irritancy of Airborne Chemicals
This standard is issued under the fixed designation E981; 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 transducers, which sense changes created by inspiration and
expiration.Theamplifiedsignalsaretransmittedtoapolygraph
1.1 This laboratory test method provides a rapid means of
recorder.
determining sensory irritant potential of airborne chemicals or
mixtures.Itmayalsobeusedtoestimatethresholdlimitvalues 2.4 The concentration of airborne irritant that produces a
(TLV) for man. However, it cannot be used to evaluate the 50% decrease in respiratory rate (RD50) is determined from
relative obnoxiousness of odors. the concentration-response curve constructed from the various
data points obtained with a series of concentrations.
1.2 This test method is intended as a supplement to, not a
replacement for, chronic inhalation studies used to establish
3. Significance and Use
allowable human tolerance levels.
3.1 This test method was developed to meet the following
1.3 This standard does not purport to address all of the
criteria:
safety concerns, if any, associated with its use. It is the
3.1.1 It provides positive recognition of sensory irritants of
responsibility of the user of this standard to establish appro-
widely varying potencies.
priate safety, health, and environmental practices and deter-
3.1.2 It is sufficiently simple to permit the testing of large
mine the applicability of regulatory limitations prior to use.
numbers of materials.
Specific hazard information is given in Section 6.
3.1.3 This test method is capable of generating
1.4 This international standard was developed in accor-
concentration-responsecurvesforpurposesofcompoundcom-
dance with internationally recognized principles on standard-
parison.
ization established in the Decision on Principles for the
3.1.4 This test method has good reproducibility.
Development of International Standards, Guides and Recom-
3.2 This test method can be used for a variety of divergent
mendations issued by the World Trade Organization Technical
purposes, including the assessment of comparative irritancy of
Barriers to Trade (TBT) Committee.
compoundsorformulationsandsettinginterimexposurelevels
2
for the workplace (1, 2).
2. Summary of Test Method
2.1 This test method quantitatively measures irritancy as 3.3 It has been shown that for a wide variety of chemicals
and mixtures, a perfect rank order correlation exists between
indicatedbythereflexinhibitionofrespirationinmiceexposed
the decreases in respiratory rate in mice and subjective reports
to sensory irritants.
of sensory irritation in man (1, 3, 4, 5).
2.2 Four mice are simultaneously exposed to the airborne
3.4 Aquantitativeestimateofthesensoryirritancyofawide
chemical. Usually a sufficient number of groups of animals are
exposed to a geometric series of concentrations so that a variety of materials can be obtained from concentration-
response curves developed using this method (1, 3, 4, 6, 7, 8,
concentration-response curve can be constructed. For simple
preliminary comparisons, however, a single group of four 9).
animals at one concentration will suffice.
3.5 Although this test method is intended to measure sen-
2.3 The mice are placed in a body plethysmograph attached sory irritation of the nasal mucosa, the cornea is innervated by
the same nerve. This animal model will, therefore, allow an
to an exposure chamber so that only the head is exposed to the
test material. The plethysmographs are connected to pressure estimate of the irritant potential of cosmetic ingredients or
other household products to the eye, assuming that they can be
aerosolized (10).
1
This test method is under the jurisdiction of ASTM Committee E50 on
3.6 This test method is recommended for setting interim
Environmental Assessment, Risk Management and Corrective Action and is the
direct responsibility of Subcommittee E50.47 on Biological Effects and Environ- guidelines for exposure of humans to chemicals in the
mental Fate.
Current edition approved Feb. 1, 2019. Published March 2019. Originally
2
approved 1984. Last previous edition approved in 2012 as E981–04(2012). DOI: Theboldfacenumbersinparenthesesrefertothelistofreferencesattheendof
10.1520/E0981-19. this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E981 − 04 (Reapproved 2012) E981 − 19
Standard Test Method for
1
Estimating Sensory Irritancy of Airborne Chemicals
This standard is issued under the fixed designation E981; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This laboratory test method provides a rapid means of determining sensory irritant potential of airborne chemicals or
mixtures. It may also be used to estimate threshold limit values (TLV) for man. However, it cannot be used to evaluate the relative
obnoxiousness of odors.
1.2 This test method is intended as a supplement to, not a replacement for, chronic inhalation studies used to establish allowable
human tolerance levels.
1.3 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use. Specific hazard information is given in Section 6.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Summary of Test Method
2.1 This test method quantitatively measures irritancy as indicated by the reflex inhibition of respiration in mice exposed to
sensory irritants.
2.2 Four mice are simultaneously exposed to the airborne chemical. Usually a sufficient number of groups of animals are
exposed to a geometric series of concentrations so that a concentration-response curve can be constructed. For simple preliminary
comparisons, however, a single group of four animals at one concentration will suffice.
2.3 The mice are placed in a body plethysmograph attached to an exposure chamber so that only the head is exposed to the test
material. The plethysmographs are connected to pressure transducers, which sense changes created by inspiration and expiration.
The amplified signals are transmitted to a polygraph recorder.
2.4 The concentration of airborne irritant that produces a 50 % decrease in respiratory rate (RD50) is determined from the
concentration-response curve constructed from the various data points obtained with a series of concentrations.
3. Significance and Use
3.1 This test method was developed to meet the following criteria:
3.1.1 It provides positive recognition of sensory irritants of widely varying potencies.
3.1.2 It is sufficiently simple to permit the testing of large numbers of materials.
3.1.3 This test method is capable of generating concentration-response curves for purposes of compound comparison.
3.1.4 This test method has good reproducibility.
3.2 This test method can be used for a variety of divergent purposes, including the assessment of comparative irritancy of
2
compounds or formulations and setting interim exposure levels for the workplace (1, 2).
3.3 It has been shown that for a wide variety of chemicals and mixtures, a perfect rank order correlation exists between the
decreases in respiratory rate in mice and subjective reports of sensory irritation in man (1, 3, 4, 5).
1
This test method is under the jurisdiction of ASTM Committee E50 on Environmental Assessment, Risk Management and Corrective Action and is the direct
responsibility of Subcommittee E50.47 on Biological Effects and Environmental Fate.
Current edition approved Dec. 1, 2012Feb. 1, 2019. Published December 2012March 2019. Originally approved 1984. Last previous edition approved in 20042012 as
E981 – 04.E981 – 04(2012). DOI: 10.1520/E0981-04R12.10.1520/E0981-19.
2
The boldface numbers in parentheses refer to the list of references at the end of this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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E981 − 19
3.4 A quantitative estimate of the sensory irritancy of a wide variety of materials can be obtained from concentration-response
curves developed using this method (1, 3, 4, 6, 7, 8, 9).
3.5 Although this test method is intended to measure sensory irritation of
...