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SUBSTANCE NAME (CASRN XX-XX-XX)

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Note: A TOXICOLOGICAL REVIEW is available for this chemical in Adobe PDF Format (xx pp, xx Kb). Similar documents can be found in the List of Available IRIS Toxicological Reviews.

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XXXX

Substance Name; CASRN xx-xx-x; xx/xx/xxxx

This U.S. EPA IRIS summary is based on the U.S. Government-sponsored technical review of the "Health Implications of Perchlorate Ingestion" by the National Research Council of the National Academies (NRC, 2005). The NRC perchlorate committee took into consideration presentations at the committee's public meetings, submitted public comments, and the comments made by technical experts on the draft NRC perchlorate report. The conclusions, recommendations and final content of the NRC (2005) report rest entirely with the committee. The NRC review follows two external draft toxicological reviews of perchlorate prepared by EPA (1998, 2002) that were also subject to public comment and independent external peer review. The IRIS summary has undergone review by EPA health scientists from several program offices, regional offices, and the Office of Research and Development. Sections I (Chronic Health Hazard Assessments for Noncarcinogenic Effects) and II (Carcinogenicity Assessment for Lifetime Exposure) present the positions that were reached during the review process. Supporting information and explanations of the methods used to derive the values given in IRIS are provided in the guidance documents located on the IRIS website at http://www.epa.gov/ncea/iris/backgr-d.htm.

STATUS OF DATA FOR Substance Name

File First On-Line xx/xx/xxxx

Category (section)
Status
Last Revised
Oral RfD Assessment (I.A.) on-line xx/xx/xxxx
Inhalation RfC Assessment (I.B.) discussion xx/xx/xxxx
Carcinogenicity Assessment (II.) on-line xx/xx/xxxx

_I.  Chronic Health Hazard Assessments for Noncarcinogenic Effects

_I.A. Reference Dose for Chronic Oral Exposure (RfD)

Substance Name — Substance Name
CASRN — xx-xx-x
Last Revised — xx/xx/xxxx

In general, the oral RfD is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily oral exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime. The RfD is based on the assumption that thresholds exist for certain toxic effects such as cellular necrosis and is expressed in units of mg/kg-day. Please refer to the background document for an elaboration of these concepts. Since RfDs can be derived for the noncarcinogenic health effects of substances that are also carcinogens, it is essential to refer to other sources of information concerning the carcinogenicity of this chemical substance. If the U.S. EPA has evaluated this substance for potential human carcinogenicity, a summary of that evaluation will be contained in Section II of this file.

__I.A.1. Oral RfD Summary

Critical Effect
Experimental Doses*
UF
RfD
xxxx xxxx
xxxx
xxxx

* Conversion Factors and Assumptions - Content Here.

__I.A.2. Principal and Supporting Studies (Oral RfD)

Content Here

__I.A.3. Uncertainty and Modifying Factors (Oral RfD)

Content Here.

__I.A.4. Additional Studies/Comments (Oral RfD)

Content Here.

For more detail on Susceptible Populations, exit to the toxicological review, Section 4.X (PDF).

__I.A.5. Confidence in the Oral RfD

Content Here.

For more detail on Characterization of Hazard and Dose Response, exit to the toxicological review, Section 6 (PDF).

__I.A.6. EPA Documentation and Review of the Oral RfD

Source Document — Content Here.

This assessment was peer reviewed by a group of external scientists. Comments from the peer reviewers were evaluated carefully and considered by the Agency during the finalization of this assessment. A record of these comments is included in Appendix A of the Toxicological Review of __________ (U.S. EPA, 200X). To review this appendix, exit to the toxicological review, Appendix XXX, Summary of and Response to External Peer Review Comments (PDF)

Other EPA Documentation — Content Here.

Agency Completion Date -- __/__/__ [note: leave this BLANK until completion is reached]

__I.A.7. EPA Contacts (Oral RfD)

Please contact the IRIS Hotline for all questions concerning this assessment or IRIS, in general, at (202) 566-1676 (phone), (202) 566-1749 (fax), or hotline.iris@epa.gov (email address).

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_I.B. Reference Concentration for Chronic Inhalation Exposure (RfC)

Substance Name — Substance Name
CASRN — xx-xx-x
Last Revised — xx/xx/xxxx

The RfC is an estimate (with uncertainty spanning perhaps an order of magnitude) of a continuous inhalation exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime. The RfC considers toxic effects for both the respiratory system (portal-of-entry) and for effects peripheral to the respiratory system (extrarespiratory effects). The inhalation RfC (generally expressed in units of mg/m3) is analogous to the oral RfD and is likewise based on the assumption that thresholds exist for certain toxic effects such as cellular necrosis. Inhalation RfCs are derived according to Methods for Derivation of Inhalation Reference Concentrations and Application of Inhalation Dosimetry (U.S. EPA, 1994). Since RfCs can also be derived for the noncarcinogenic health effects of substances that are carcinogens, it is essential to refer to other sources of information concerning the carcinogenicity of this chemical substance. If the U.S. EPA has evaluated this substance for potential human carcinogenicity, a summary of that evaluation will be contained in Section II of this file.

__I.B.1. Inhalation RfC Summary

Critical Effect
Experimental Doses*
UF
RfC
xxxx xxxx
xxxx
xxxx

* Conversion Factors and Assumptions - Content Here.

__I.B.2. Principal and Supporting Studies (Inhalation RfC)

Content Here.

__I.B.3. Uncertainty and Modifying Factors (Inhalation RfC)

Content Here.

__I.B.4. Additional Studies/Comments (Inhalation RfC)

Content Here.

For more detail on Susceptible Populations, exit to the toxicological review, Section 4.X (PDF).

__I.B.5. Confidence in the Inhalation RfC

Content Here.

For more detail on Characterization of Hazard and Dose Response, exit to the toxicological review, Section 6 (PDF)

__I.B.6. EPA Documentation and Review of the Inhalation RfC

Source Document — Content Here.

This assessment was peer reviewed by a group of external scientists. Comments from the peer reviewers were evaluated carefully and considered by the Agency during the finalization of this assessment. A record of these comments is included in Appendix A of the Toxicological Review of __________ (U.S. EPA, 200X). To review this appendix, exit to the toxicological review, Appendix XXX, Summary of and Response to External Peer Review Comments (PDF)

Other EPA Documentation — Content Here.

Agency Completion Date -- __/__/__ [note: leave this BLANK until completion is reached]

__I.B.7. EPA Contacts (Inhalation RfC)

Please contact the IRIS Hotline for all questions concerning this assessment or IRIS, in general, at (202) 566-1676 (phone), (202) 566-1749 (fax), or hotline.iris@epa.gov (email address).

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_II.  Carcinogenicity Assessment for Lifetime Exposure

Substance Name — Substance Name
CASRN — xx-xx-x
Last Revised — xx/xx/xxxx

This section provides information on three aspects of the carcinogenic assessment for the substance in question: the weight-of-evidence judgment of the likelihood that the substance is a human carcinogen, and quantitative estimates of risk from oral and inhalation exposure. Users are referred to Section I of this file for information on long-term toxic effects other than carcinogenicity.

The rationale and methods used to develop the carcinogenicity information in IRIS are described in the Draft Revised Guidelines for Carcinogen Risk Assessment (U.S. EPA, 1999). The quantitative risk estimates are derived from the application of a low-dose extrapolation procedure, and are presented in two ways to better facilitate their use. First, route-specific risk values are presented. The "oral slope factor" is an upper bound on the estimate of risk per mg/kg-day of oral exposure. Similarly, a "unit risk" is an upper bound on the estimate of risk per unit of concentration, either per µg/L drinking water (see Section II.B.1.) or per µg/m3 air breathed (see Section II.C.1.). Second, the estimated concentration of the chemical substance in drinking water or air when associated with cancer risks of 1 in 10,000, 1 in 100,000, or 1 in 1,000,000 is also provided.

_II.A. Evidence for Human Carcinogenicity

__II.A.1. Weight-of-Evidence Characterization

Content Here.

For more detail on Characterization of Hazard and Dose Response, exit to the toxicological review, Section 6 (PDF).

For more detail on Susceptible Populations, exit to the toxicological review, Section 4.X (PDF).

__II.A.2. Human Carcinogenicity Data

Content Here.

__II.A.3. Animal Carcinogenicity Data

Content Here.

__II.A.4. Supporting Data for Carcinogenicity

Content Here.

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_II.B. Quantitative Estimate of Carcinogenic Risk from Oral Exposure

Not applicable.

__II.B.1. Summary of Risk Estimates

Content Here.

__II.B.2. Dose-Response Data (Carcinogenicity, Oral Exposure)

Content Here.

__II.B.3. Additional Comments (Carcinogenicity, Oral Exposure)

Content Here.

__II.B.4. Discussion of Confidence (Carcinogenicity, Oral Exposure)

Content Here.

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_II.C. Quantitative Estimate of Carcinogenic Risk from Inhalation Exposure

Content Here.

__II.C.1. Summary of Risk Estimates

Content Here.

__II.C.2. Dose-Response Data for Carcinogenicity, Inhalation Exposure

Content Here.

__II.C.3. Additional Comments (Carcinogenicity, Inhalation Exposure)

Content Here.

__II.C.4. Discussion of Confidence (Carcinogenicity, Inhalation Exposure

Content Here.

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_II.D. EPA Documentation, Review, and Contacts (Carcinogenicity Assessment)

__II.D.1. EPA Documentation

Source Document — Content Here.

This assessment was peer reviewed by a group of external scientists. Comments from the peer reviewers were evaluated carefully and considered by the Agency during the finalization of this assessment. A record of these comments is included in Appendix A of the Toxicological Review of __________ (U.S. EPA, 200X). To review this appendix, exit to the toxicological review, Appendix X, Summary of and Response to External Peer Review Comments (PDF).

Other EPA Documentation — Content Here.

__II.D.2. EPA Review (Carcinogenicity Assessment)

Agency Consensus Date - xx/xx/xxxx

__II.D.3. EPA Contacts (Carcinogenicity Assessment

Please contact the IRIS Hotline for all questions concerning this assessment or IRIS, in general, at (202) 566-1676 (phone), (202) 566-1749 (fax), or hotline.iris@epa.gov (email address).

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_III.  [reserved]
_IV.  [reserved]
_V.  [reserved]


_VI.  Bibliography

Substance Name — Susbstance Name
CASRN — xx-xx-x
Last Revised — xx/xx/xxxx

_VI.A. Oral RfD References

Content Here.

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_VI.B. Inhalation RfC References

Content Here.

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_VI.C. Carcinogenicity Assessment References

Content Here.

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_VII.  Revision History

Substance Name — Substance Name
CASRN — xx-xx-x

Date
Section
Description
xx/xx/xxxx xxxx xxxx

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_VIII.  Synonyms

Substance Name — Substance Name
CASRN — xx-xx-x
Last Revised — xx/xx/xxxx

xxxx

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