SRC TR-10-121

HPV4 CHEMICAL DATA ADEQUACY REVIEW

Quaternary ammonium compounds, (oxydi-2,1-ethanediyl)bis[coco alkyldimethyl,dichlorides, 

CAS No. 68607-28-3

Prepared by:

Chris Janson, Justine Von Runnen, and Joan D. Garey

Chemical, Biological and Environmental Center

SRC, Inc.

7502 Round Pond Road

North Syracuse, NY 13212

Contract No. EP-W-09-027

Task FG007.0.009.002

Submitted to:

OPPT/RAD/HPVCB (7403M)

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue

Washington, D.C. 20460

Elizabeth Margosches, Alternate Project Officer

Meena Sonawane, Work Assignment Manager

David Brooks, Alternate Work Assignment Manager

July 13, 2010
HPV4 Chemical Data Adequacy Review

Quaternary ammonium compounds, (oxydi-2,1-ethanediyl)bis[coco alkyldimethyl,dichlorides, 

CAS No. 68607-28-3

July 2010

Submitted to:

High Production Volume Chemicals Branch 

Risk Assessment Division 

Office of Pollution Prevention and Toxics 

Environmental Protection Agency 

WAM: Meena Sonawane

Alternate WAM: David Brooks

1200 Pennsylvania Avenue, NW 

Washington, DC 20460-0001

Prepared By:

SRC, Inc. 

Environmental Science Center 

2451 Crystal Drive, Suite 804 

Arlington, VA 22202
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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A. PREPARATION OF THE DATA ADEQUACY ASSESSMENTS

A-1. Source material used for assessment

For this unsponsored chemical, a comprehensive literature search was performed to 

identify available toxicity data for the following SIDS endpoints:

Acute toxicity to fish

Acute toxicity to Daphnia

Toxicity to aquatic plants

Acute (oral, dermal, inhalation) toxicity

Repeated-dose toxicity

Reproductive toxicity

Developmental toxicity

Gene mutation

Chromosomal aberrations

Studies relevant to non-SIDS endpoints (e.g., eye and skin irritation; neurotoxicity) conducted 

via oral, inhalation, or dermal routes were also identified through literature searching.

The following sources were searched for toxicity data:

PubMed - Bibliographic database that contains references to journal articles in the life 

sciences with a concentration on biomedicine

TOXNET -National Library of Medicine databases on toxicology, hazardous chemicals, 

environmental health, and toxic releases; includes: 

• TOXLINE with BIOSIS and NTIS;

• Development and Reproductive Toxicology File (DART);

• Chemical Carcinogenesis Research Information System (CCRIS) -

Carcinogenicity and mutagenicity test results for over 8000 

• chemicals);

• Hazardous Substances Data Bank (HSDB) - Comprehensive, peerreviewed toxicology data for about 5000 chemicals;

• Genetic Toxicology Data Bank (GENE-TOX) - Peer-reviewed genetic 

toxicology test data for over 3000 chemicals.

TSCATS - Unpublished technical reports submitted by industry to the EPA under the 

Toxic Substances Control Act]

Registry of toxic effects of chemical substances (RTECs)

Environmental Fate Database (EFDB)

ECOTOX -EPA’s peer-reviewed ecotoxicology database
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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EPA’s Integrated Risk Information System (IRIS) website

Agency for Toxic Substances and Disease Registry (ATSDR) website

National Toxicology Program (NTP) website

International Program on Chemical Safety Concise International Chemical Assessment 

Documents (IPCS INCHEM or CICADs)

European Chemical Substances Information System (ESIS) - source of IUCLID Datasets

Any available IUCLID Datasets found through the ESIS website and robust summaries 

submitted to EPA by former sponsors on the assigned chemicals were retrieved. Original 

sources were obtained for any relevant toxicity data found for the assigned chemicals. 

While IUCLID Datasets sometimes contained studies of interest, certain study 

descriptions contained insufficient detail to assess adequacy. In these cases, the primary source 

of the study, if available and accessible, was obtained and reviewed.

A-2. Evaluating data adequacy

Using standard OECD testing guidelines and professional judgment as guides, available 

toxicity studies for the unsponsored chemical were reviewed for adequacy. Summaries were 

prepared for all relevant data found, even if little or no study detail was available. Each study 

was summarized according to a standard format and assigned a Klimisch reliability code; all 

study summaries for the chemical were combined into a single summary document. For studies 

already assigned Klimisch codes (e.g., studies summarized in IUCLID datasets), an explanation 

was provided if the reviewer’s assessment of data adequacy differed from the pre-assigned 

Klimisch code. A table summarizing data availability/adequacy for each SIDS endpoint is 

included at the end of the summary document. 

B. SPECIFIC INFORMATION ON THE AVAILABLE TOXICITY DATA

The available data for each of the SIDS toxicity endpoints are evaluated on the following 

pages. Studies for a common endpoint are grouped together in the document and an endpoint 

adequacy assessment is provided near the top of the first page of the summaries for that 

endpoint. If the data available for the endpoint is determined to be inadequate, a basis for that 

conclusion is supplied. 

The Group I Quat Cluster is a group of structurally similar quaternary ammonium 

compounds (“quats”) that are characterized by having a positively charged nitrogen covalently 

bonded to two alkyl group substituents (at least one C8 or longer) and two methyl substituents. 

In finished form, these quats are salts with a positively charged nitrogen (cation) balanced by a 

negatively charged molecule (anion). The anion for the quats in this cluster is chloride or 

bromide. 
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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Both quaternary ammonium compounds, (oxydi-2,1-ethanediyl)bis[coco alkyldimethyl, 

dichlorides (CAS No. 68607-28-3) and didecyldimethylammonium chloride (DDAC, CAS No. 

7173-51-5), were designated by EPA’s OPP as active ingredients in the Group I Quat Cluster. : 

The close structural relationship between quaternary ammonium compounds, (oxydi-2,1-

ethanediyl)bis[coco alkyldimethyl,dichlorides and DDAC justifies the use of DDAC as an analog 

in this data adequacy review. 
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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B-1. TOXICITY TO FISH 

Summary of endpoint: Adequate

Study 1: Acute toxicity study in bluegill sunfish

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

This study is not adequate due to lack of study details and use of a mixture for testing.

TEST SUBSTANCE 

Identity: X-Cide 370

Remarks: Test substance is 36% oxydiethylene bis (coco alkyl dimethyl ammonium chloride) 

and ~ 33% methanol.

METHOD

Method/guideline followed: Not stated

Test type: Flow-through, time independent bioassay

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Bluegill

Analytical monitoring: Not stated

Exposure duration: Not stated

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC50 = 0.46 mg/L (nominal)

Results remarks: None stated

CONCLUSIONS
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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None stated

STUDY RELIABILITY

[3] Not reliable – lack of study details and use of mixture

REFERENCE

TSCATS submission (OTS0533639, Doc ID 88-910000287, received 09/25/91): Petrolite Corp. 

1991. Follow-up information from Petrolite Corporation to USEPA submitting enclosed data 

concerning oxydiethylene bis(alkyl dimethyl ammonium chloride) with attachments. 
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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Title: Aquatic Toxicity

Study 2: Acute toxicity study in fathead minnow

This study is: Adequate Not Adequate

This study is not adequate due to lack of study details and use of a mixture for testing.

TEST SUBSTANCE 

Identity: X-Cide 370

Remarks: Test substance is 36% oxydiethylene bis (coco alkyl dimethyl ammonium chloride) 

and ~ 33% methanol.

METHOD

Method/guideline followed: Not stated

Test type: Static

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Fathead minnow

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC50 = 0.42 mg/L (nominal)

Results remarks: None stated

CONCLUSIONS

None stated
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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STUDY RELIABILITY

[3] Not reliable – lack of study details and use of mixture

REFERENCE

TSCATS submission (OTS0533639, Doc ID 88-910000287, received 09/25/91): Petrolite Corp. 

1991. Follow-up information from Petrolite Corporation to USEPA submitting enclosed data

concerning oxydiethylene bis(alkyl dimethyl ammonium chloride) with attachments
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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Study 3: Acute toxicity study in fathead minnow

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

This study is not adequate due to lack of study details and use of a mixture for testing.

TEST SUBSTANCE 

Identity: X-Cide 370

Remarks: Test substance is 36% oxydiethylene bis (coco alkyl dimethyl ammonium chloride) 

and ~ 33% methanol.

METHOD

Method/guideline followed: Not stated

Test type: Static

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Fathead minnow

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: Test was carried out in natural water containing suspended 

and dissolved solids

RESULTS

Endpoint value(s): LC50 = 4.0 mg/L (nominal)

Results remarks: None stated

CONCLUSIONS

None stated
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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STUDY RELIABILITY

[3] Not reliable – lack of study details and use of mixture

REFERENCE

TSCATS submission (OTS0533639, Doc ID 88-910000287, received 09/25/91): Petrolite Corp. 

1991. Follow-up information from Petrolite Corporation to USEPA submitting enclosed data 

concerning oxydiethylene bis(alkyl dimethyl ammonium chloride) with attachments
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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Study 4: Acute toxicity study in fathead minnow

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

This study is not adequate due to lack of study details and use of a mixture for testing.

TEST SUBSTANCE 

Identity: X-Cide 370

Remarks: Test substance is 36% oxydiethylene bis (coco alkyl dimethyl ammonium chloride) 

and ~ 33% methanol.

METHOD

Method/guideline followed: Not stated

Test type: Static

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Fathead minnow

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: Testing was carried out in a synthetic water containing 50 

mg/L clay

RESULTS

Endpoint value(s): LC50 = 13.4 mg/L (nominal)

Results remarks: None stated

CONCLUSIONS

None stated
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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STUDY RELIABILITY

[3] Not reliable – lack of study details and use of mixture

REFERENCE

TSCATS submission (OTS0533639, Doc ID 88-910000287, received 09/25/91): Petrolite Corp. 

1991. Follow-up information from Petrolite Corporation to USEPA submitting enclosed data 

concerning oxydiethylene bis(alkyl dimethyl ammonium chloride) with attachments
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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Study 5: Acute toxicity study in armed bullhead

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

This study is not adequate due to lack of study details and use of a mixture for testing. 

Additionally, the test species is not a preferred species.

TEST SUBSTANCE 

Identity: X-Cide 370

Remarks: Test substance is 36% oxydiethylene bis (coco alkyl dimethyl ammonium chloride) 

and ~ 33% methanol.

METHOD

Method/guideline followed: Not stated

Test type: Static

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Armed bullhead

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC50 = 0.40 mg/L (nominal)

Results remarks: None stated

CONCLUSIONS

None stated
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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STUDY RELIABILITY

[3] Not reliable – lack of study details, use of a mixture, tested on a species that is not preferred

REFERENCE

TSCATS submission (OTS0533639, Doc ID 88-910000287, received 09/25/91): Petrolite Corp. 

1991. Follow-up information from Petrolite Corporation to USEPA submitting enclosed data 

concerning oxydiethylene bis(alkyl dimethyl ammonium chloride) with attachments
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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Study 6: Acute toxicity in plaice

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

This study is not adequate due to lack of study details and use of a mixture for testing.

TEST SUBSTANCE 

Identity: X-Cide 370

Remarks: Test substance is 36% oxydiethylene bis (coco alkyl dimethyl ammonium chloride) 

and ~ 33% methanol.

METHOD

Method/guideline followed: Not stated

Test type: Static

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Plaice

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC50 = 1.2 mg/L (nominal)

Results remarks: None stated

CONCLUSIONS

None stated
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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STUDY RELIABILITY

[3] Not reliable – lack of study details and use of a mixture

REFERENCE

TSCATS submission (OTS0533639, Doc ID 88-910000287, received 09/25/91): Petrolite Corp. 

1991. Follow-up information from Petrolite Corporation to USEPA submitting enclosed data 

concerning oxydiethylene bis(alkyl dimethyl ammonium chloride) with attachments
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

16

Study 7: Acute toxicity study in sheepshead minnow

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

This study is not adequate due to lack of study details and use of a mixture for testing.

TEST SUBSTANCE 

Identity: X-Cide 370

Remarks: Test substance is 36% oxydiethylene bis (coco alkyl dimethyl ammonium chloride) 

and ~ 33% methanol.

METHOD

Method/guideline followed: Not stated

Test type: Static

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Sheepshead minnow

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC50 = 0.55 mg/L (nominal)

Results remarks: None stated

CONCLUSIONS

None stated
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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STUDY RELIABILITY

[3] Not reliable – lack of study details and use of a mixture

REFERENCE

TSCATS submission (OTS0533639, Doc ID 88-910000287, received 09/25/91): Petrolite Corp. 

1991. Follow-up information from Petrolite Corporation to USEPA submitting enclosed data 

concerning oxydiethylene bis(alkyl dimethyl ammonium chloride) with attachments
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

18

Study 8: Acute toxicity study in sheepshead minnow

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

This study is not adequate due to lack of study details and use of a mixture for testing.

TEST SUBSTANCE 

Identity: X-Cide 370

Remarks: Test substance is 36% oxydiethylene bis (coco alkyl dimethyl ammonium chloride) 

and ~ 33% methanol.

METHOD

Method/guideline followed: Not stated

Test type: Static

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Sheepshead minnow

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: Testing was conducted in synthetic seawater containing 25 

mg/L clay.

RESULTS

Endpoint value(s): LC50 = 6.8 mg/L (nominal)

Results remarks: None stated

CONCLUSIONS

None stated
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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STUDY RELIABILITY

[3] Not reliable – lack of study details and use of a mixture

REFERENCE

TSCATS submission (OTS0533639, Doc ID 88-910000287, received 09/25/91): Petrolite Corp. 

1991. Follow-up information from Petrolite Corporation to USEPA submitting enclosed data 

concerning oxydiethylene bis(alkyl dimethyl ammonium chloride) with attachments
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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Study 9: Aquatic toxicity study of DDAC in bluegill sunfish

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: Not stated

METHOD

Method/guideline followed: Not stated

Test type: Static

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Bluegill sunfish, Lepomis macrochirus

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC50 = 0.32 mg/L (measured)

Results remarks: None stated

CONCLUSIONS

None stated

STUDY RELIABILITY

[2] Reliable with restrictions
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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REFERENCE

LeLievre, M.k. 1990A

MRID# - 41578001
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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Study 10: Aquatic toxicity study of DDAC in coho salmon

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: Not stated

METHOD

Method/guideline followed: Not stated

Test type: Static

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Coho salmon, Oncorhynchus kisutch

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC50 = 1.0 mg/L (measured)

Results remarks: None stated

CONCLUSIONS

None stated

STUDY RELIABILITY

[2] Reliable with restrictions
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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REFERENCE

LeLievre, M.K. 1990b

MRID# - 41578003
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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Study 11: Aquatic toxicity study of DDAC in rainbow trout

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: Not stated

METHOD

Method/guideline followed: Not stated

Test type: Acute toxicity

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Rainbow trout, Oncorhynchus mykiss

Analytical monitoring: Not stated

Exposure duration: Not stated

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC50 = 478 mg/L

Results remarks: Practically non-toxic

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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REFERENCE

Rhodes, R.E. 2000a

MRID# - 41592002
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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Study 12: Aquatic toxicity study of DDAC in bluegill sunfish

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: Not stated

METHOD

Method/guideline followed: Not stated

Test type: Acute toxicity

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Bluegill sunfish, Lepomis macrochirus

Analytical monitoring: Not stated

Exposure duration: Not stated

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC50 = 188 mg/L 

Results remarks: Practically non-toxic

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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REFERENCE

Rhodes, R.E. 2000b

MRID# - 41592001
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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Study 13: Aquatic toxicity study of DDAC in sheepshead minnow

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: Not stated

METHOD

Method/guideline followed: Not stated

Test type: Static acute

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Sheepshead minnow, Cyprinodon variegatus

Analytical monitoring: Not stated

Exposure duration: Not stated

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC50 = 0.96 mg/L

Results remarks: Highly toxic

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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REFERENCE

Collins, M.K. 1994

MRID# - 43620001
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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Study 14: Aquatic toxicity study of DDAC in bluegill sunfish

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: Not stated

METHOD

Method/guideline followed: Not stated

Test type: Acute toxicity

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Bluegill sunfish, Lepomis macrochirus

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC50 = 0.5 mg/L 

Results remarks: Highly toxic

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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REFERENCE

Onyx Chemical Co. 1982a

PROJ# - 038901
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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Study 15: Aquatic toxicity study of DDAC in rainbow trout

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: Not stated

METHOD

Method/guideline followed: Not stated

Test type: Acute toxicity

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Rainbow trout, Oncorhynchus mykiss

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC50 = 2.8 mg/L

Results remarks: Moderately toxic

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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REFERENCE

Onyx Chemical Co. 1982b

PROJ# - 038901
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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Study 16: Aquatic toxicity study of DDAC in rainbow trout

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: Not stated

METHOD

Method/guideline followed: Not stated

Test type: Acute toxicity

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Rainbow trout, Oncorhynchus mykiss

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC50 = 1.6 mg/L 

Results remarks: Moderately toxic

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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REFERENCE

Supremant D.C. 1986 ACC# - 40129801
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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Study 17: Aquatic toxicity study of DDAC in bluegill sunfish

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: Not stated

METHOD

Method/guideline followed: Not stated

Test type: Acute static

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Bluegill sunfish, Lepomis macrochirus

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC50 = 0.27 mg/L

Results remarks: None stated

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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REFERENCE

Wells Labs 1971a

ACC# - 007958
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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Study 18: Aquatic toxicity study of DDAC in rainbow trout

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: Not stated

METHOD

Method/guideline followed: Not stated

Test type: Acute static

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Rainbow trout, Oncorhynchus mykiss

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC50 = 1.1 mg/L 

Results remarks: None stated

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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REFERENCE

Wells Labs 1971b

ACC# - 007958
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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B-2. TOXICITY TO AQUATIC INVERTEBRATES

Summary of endpoint: Adequate

Study 1: Acute toxicity study in brown shrimp

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

This study is not adequate due to lack of study details and use of a mixture for testing.

TEST SUBSTANCE 

Identity: X-Cide 370

Remarks: Test substance is 36% oxydiethylene bis (coco alkyl dimethyl ammonium chloride) 

and ~ 33% methanol.

METHOD

Method/guideline followed: Not stated

Test type: Static

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Brown shrimp

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: Not stated

RESULTS

Endpoint value(s): The 96-hour LC50 = 34.0 mg/L (nominal)

Results remarks: None stated

CONCLUSIONS
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

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None stated

STUDY RELIABILITY

[3] Not reliable – lack of study details and testing on a mixture

REFERENCE

TSCATS submission (OTS0533639, Doc ID 88-910000287, received 09/25/91): Petrolite Corp. 

1991. Follow-up information from Petrolite Corporation to USEPA submitting enclosed data 

concerning oxydiethylene bis(alkyl dimethyl ammonium chloride) with attachments
Draft HPV4 Chemical Data Adequacy Review CAS No. 68607-28-3

42

Study 2: Acute toxicity study in grass shrimp

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

This study is not adequate due to lack of study details and use of a mixture for testing.

TEST SUBSTANCE 

Identity: X-Cide 370

Remarks: Test substance is 36% oxydiethylene bis (coco alkyl dimethyl ammonium chloride) 

and ~ 33% methanol.

METHOD

Method/guideline followed: Not stated

Test type: Static

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Grass shrimp

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: Not stated

RESULTS

Endpoint value(s): The 96-hour LC50 = 4.0 mg/L (nominal)

Results remarks: None stated

CONCLUSIONS

None stated

STUDY RELIABILITY
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[3] Not reliable – lack of study details and testing on a mixture

REFERENCE

TSCATS submission (OTS0533639, Doc ID 88-910000287, received 09/25/91): Petrolite Corp. 

1991. Follow-up information from Petrolite Corporation to USEPA submitting enclosed data 

concerning oxydiethylene bis(alkyl dimethyl ammonium chloride) with attachments
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Study 3: Acute toxicity study of DDAC in Daphnia magna

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: Not sated

METHOD

Method/guideline followed: Not stated

Test type: Static

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Daphnia magna

Analytical monitoring: Not stated

Exposure duration: 48 hours

Concentrations tested: Not stated

Test method/conditions remarks: Not stated

RESULTS

Endpoint value(s): The 48-hour LC50 = 0.018 mg/L 

Results remarks: Very highly toxic

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid
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REFERENCE

Onyx Chemical Co. 1982c

PROJ# - 038901
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Study 4: Acute toxicity study of DDAC in Daphnia magna

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: Not sated

METHOD

Method/guideline followed: Not stated

Test type: Static

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Daphnia magna

Analytical monitoring: Not stated

Exposure duration: 48 hours

Concentrations tested: Not stated

Test method/conditions remarks: Not stated

RESULTS

Endpoint value(s): The 48-hour EC50 = 94 μg/L 

Results remarks: Very highly toxic

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid
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REFERENCE

LeLievre, M.K. 1990c

MRID# - 41578002
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Study 5: Acute toxicity study of DDAC in Daphnia pulex

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: None stated

METHOD

Method/guideline followed: None stated

Test type: Acute toxicity

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Daphnia pulex

Analytical monitoring: Not stated

Exposure duration: 48 hours

Concentrations tested: Not stated

Test method/conditions remarks: Not stated

RESULTS

Endpoint value(s): The 48-hour LC50 = 0.052 mg/L

Results remarks: Very highly toxic

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid
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REFERENCE

Surprenant, E.C. 1987

ACC# - 40129801, 02, 03
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Study 6: Acute toxicity study of DDAC in Daphnia magna

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: None stated

METHOD

Method/guideline followed: None stated

Test type: Static

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Daphnia magna

Analytical monitoring: Not stated

Exposure duration: 48 hours

Concentrations tested: Not stated

Test method/conditions remarks: Not stated

RESULTS

Endpoint value(s): The 48-hour LC50 = 0.095 mg/L

Results remarks: None stated

CONCLUSIONS

None stated

STUDY RELIABILITY

[2] Valid with restrictions
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REFERENCE

Roberts, S. 1977

No. – 7E-6686
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Study 7: Acute toxicity study of DDAC in Daphnia magna

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: None stated

METHOD

Method/guideline followed: None stated

Test type: Static

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Daphnia magna

Analytical monitoring: Not stated

Exposure duration: 48 hours

Concentrations tested: Not stated

Test method/conditions remarks: Not stated

RESULTS

Endpoint value(s): The 48-hour LC50 = 0.1 mg/L

Results remarks: None stated

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid
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REFERENCE

Canon Labs 1976

ACC# - 225596
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Study 8: Acute toxicity study of DDAC in mysid shrimp

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: None stated

METHOD

Method/guideline followed: None stated

Test type: Static

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Mysidopsis bahia

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: Not stated

RESULTS

Endpoint value(s): The 96-hour LC50 = 69 μg/L

Results remarks: Very highly toxic

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid
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REFERENCE

LeLievre, M. K. 1990d

MRID# - 41578004
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B-3. TOXICITY TO AQUATIC PLANTS

Summary of endpoint: Adequate

Study 1: Acute toxicity of DDAC in Selenastrum capricornutum

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: Not sated

METHOD

Method/guideline followed: Not stated

Test type: Not stated

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Selenastrum capricornutum

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: Using natural surface water

RESULTS

Endpoint value(s): The 96-hour EC50 = 0.0732 mg/L 

NOEC = 0.027 mg/L

Results remarks: None stated

CONCLUSIONS

None stated
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STUDY RELIABILITY

[1] -Valid

REFERENCE

Krueger, H.O. et al. 2003

MRID# - 45896401
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Study 2: Acute toxicity of DDAC in Selenastrum capricornutum

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: Not sated

METHOD

Method/guideline followed: Not stated

Test type: Not stated

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Selenastrum capricornutum

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: Using natural surface water

RESULTS

Endpoint value(s): The 96-hour EC50 = 0.01422 mg/L 

NOEC = 0.008 mg/L

Results remarks: None stated

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] - Valid
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REFERENCE

Krueger, H.O. et al. 2003

MRID# - 45896401
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B-4. ACUTE TOXICITY

Summary of endpoint: Adequate

Study 1: Acute inhalation toxicity study in rats

Title: ENV900101 Acute Inhalation Toxicity, LC50, 4-Hour Exposure - Rats

The study is: Adequate Not Adequate

This study is not adequate for the acute toxicity endpoint because a mixture was tested.

TEST SUBSTANCE 

Identity: X-Cide 370 Industrial Biocide. 

Remarks: Test substance is 36% oxydiethylene bis (coco alkyl dimethyl ammonium chloride) 

and ~ 33% methanol.

METHOD

Method/guideline followed: 40 CFR Part 158 Series 81-3, EPA Pesticide Assessment 

Guidelines – Subdivision F – Hazard Evaluation – Human & Domestic Animals, November 

1984

Test type: Acute inhalation toxicity

GLP compliant?: Yes

Year study performed: 1990

Species/Strain: Sprague-Dawley rat (200 to 279 grams). Obtained from Buckshire Corp., 

Perkasie, PA 18944

Number of animals/sex/dose: 5/sex

Route of administration: Inhalation

Vehicle: Air

Doses/concentrations tested: 1.02, 1.15, 2.52 mg/L

Statistical methods used: Litchfield & Wilcoxon Method

Test method/conditions remarks: The test article was generated as a 50%, 33% and a 25% w/w 

dilution in deionized water. 
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Three groups of ten (5 male & 5 female) rats were exposed to the test article inside a 230 liter 

exposure chamber for four hours. The test article was administered as an aerosol generated by 

an eight jet Collision nebulizer fed by a RAZEL Model A Syringe Pump. The air was passed 

through a dessicant prior to being passed through the test article. The rate of flow through the 

chamber in liters per minute, temperature and humidity were monitored continuously and were 

recorded at least every 30 minutes. 

Initially, an additional exposure level was conducted. Due to difficulties during the analytical 

determination, the resulting values were not used in determining the LC50. 

Dynamic air flow of 45.5 – 53.5 lpm ensures at least 10 air changes per hour. The chamber air 

temperature at which the test was performed was maintained at 20 C (+/- 2 C) (dry bulb).

The oxygen level was monitored with a Biomarine 300 RX Oxygen Monitor.

The nominal average concentration of the aerosol (which is only a rough estimate of the airborne 

concentration) over the 4-hour exposure period was calculated by differential weighting of the 

flask from which the aerosol was generated.

Three dose levels, spaced appropriately, were administered to permit an acceptable 

determination of the LC50.

Particle size analyses were carried out once each hour during the exposure at each dose level. 

Particle size of the aerosol was determined using an Anderson Cascade Impactor. During 

sampling, air from the breathing zone of the animals was drawn through the cascade impactor at 

the rate of 1 cubic foot per minute (28.3liters per minute). The amount of aerosol impacting on 

each plate of the Anderson Cascade Impactor was determined by differential weighing. From 

these values the mass median aerodynamic diameter of the aerosol was calculated. The 

respirable concentration (particles less than or equal to 9 micrometers aerodynamic diameter) 

was also calculated from the mass collected on the appropriate plates divided by the total air 

volume sampled. In addition, the nominal gravimetric concentration was determined from the 

total mass collected by the Andersen Cascade Impactor.

Gravimetric determination of the chamber atmospheric concentration was determined by 

sampling air from the breathing zone through a glass filter (99.5% efficient for 0.3 micron 

particles). The airborne concentration of nonvolatile materials was determined by the weight 

gain of the filter divided by the volume of air sampled.

Four sets of tandem midget impinge samples were taken at 60, 120, 180 and 235 minutes through 

each exposure. Initially, 20 ml of methanol were placed into each of the two impingers, and 

during sampling, 28-36 liters of air were drawn through the impingers arranged in a series at a 

flow rate of approximately 2.6 l/min. Following completion of sampling, the methanol 

collecting fluid in each impinge was measured and made up to 20 ml with methanol. The sets of 

samples were then returned to the Patrick Center at the Philadelphia Academy of Natural Science 

for analytical determination. These results were reported to Biosearch for use in calculations and 
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for additional studies.

Following the 4-hour inhalation exposures, the chamber was purged with clean air for 30 

minutes. The animals were returned to their cages, allowed food and water ad libitum, and 

observed for a 14-day period for signs of toxicity and mortality. Animals were observed 

frequently during the day of exposure, and twice per day (morning and afternoon) on weekdays. 

On the weekends and holidays, animals were observed twice per day. Individual weights were 

recorded on Day 0 (prior to exposure), Day 7 and Day 14 (prior to sacrifice).

The animals were euthanized at the conclusion of the observation period by intraperitoneal 

injection of a sodium pentobarbital overdose. Gross necropsies were performed on all animals. 

Additionally, the lungs, liver and kidneys and any other organs showing evidence of gross 

pathology were fixed in 10% buffered formalin for possible future histopathological 

examination.

RESULTS

Endpoint value(s): LC50 = 1.05

Results remarks: Mortalities were observed at all three exposure levels. At the 1.02 mg/L dose 

level, two males and two females were found dead on Day 1, two males were found dead on Day 

2 and one female was found dead on Day 11. At the 1.15 mg/L dose level, one male and two 

females were found dead on Day 2. At the 2.52 mg/L dose level, two males and two females 

were found dead on Day 2, two males and one female were found dead on Day 2, one male and 

one female were found dead on Day 3 and one female was found dead on Day 12. Partially 

closed eyes, head nodding, inactivity and/or hypoactivity, wet and/or wet stained noses were 

observed during the 4-hour exposure. Upon being returned to holding cages, red-brown muzzle 

staining, wet anogenital areas, moist rales, wheezing and/or gasping were observed. Red-brown 

stained muzzles, wet yellow anogenital areas, ruffled hair, moist rales and gasping were seen at 

some tine throughout the 14-day observation periods. At all three exposure levels. All surviving 

animals exhibited weight losses from Day 0-7. In the 1.02 mg/L group, male #31 exhibited a 

weight loss from Day 7-14. In the 1.15 mg/L group female #27 exhibited a weight loss from 

Day 7-14, three males and one female exhibited weight gains from Day7-14 but not recoveries to

their initial weights.

At gross necropsy examinations, red-brown muzzle staining (6/30 animals) brown muzzle 

staining (10/30 animals), yellow/anogenital staining (22/30 animals), gas-filled gastrointestinal 

tracts (5/30 animals), absence of adipose tissue (8/30 animals), no formed feces (3/30 animals) 

red patchy areas throughout lungs or dark red lungs (18/30 animals) were observed.

CONCLUSIONS

By calculation using the Litchfield & Wilcoxon Method, the LC50 for males and females 

combined is 1.05 mg/L; for male rats only, is 1.03 mg/L; and, for female rats only, is 1.06 mg/L 

(by analytical determination). The particles in the aerosol were within the respirable range.
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A low percentage of submicron droplets was collected from the chamber. The size cut just 

above that including 1.0 μm was quite large and constituted an overall average of 26.07% (range 

3.57 to 52.12) of the sampled particles with an effective cut-off diameter of 1.1μm or smaller.

When the gravimetric filter concentration is compared with the analytical concentration, 2.50 –

84.81% of the analytical concentration is missed by the gravimetric measurement. This 

sampling technique would not miss large particulates, only very small particulates or vapor 

material, which would pass through the filter. Therefore, on average 59.31% of the airborne 

sample in excess of that collected by the cascade impactor was in the submicron or vapor phase 

and could not be detected by the cascade impactor.

STUDY RELIABILITY

[3] – Not reliable – testing conducted on a mixture.

REFERENCE

TSCATS submission (OTS0533639, Doc ID 88-910000209, received 07/17/91): Biosearch Inc, 

Petrolite Corp. 1990. Initial submission: Summary of results from an acute inhalation toxicity 

study in rats with oxydiethylene bios (alkyl dimethyl ammonium chloride) with cover letter 

dated 071291.
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Study 2: Acute oral toxicity study of DDAC in rats

Title: Acute oral toxicity

The study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: Purity 65%

METHOD

Method/guideline followed: 870.1100

Test type: Acute oral toxicity

GLP compliant?: Not stated

Year study performed: Not stated

Species/Strain: Rats, strain not specified

Number of animals/sex/dose: 5/sex

Route of administration: Gavage

Vehicle: Not stated

Doses/concentrations tested: 0, 100, 200 or 400 mg/kg-bw for females; 0, 100, 200, 283, 336 or 

400 mg/kg-bw/day for males

Statistical methods used: Not stated

Test method/conditions remarks: Animals were administered the test substance via gavage and 

observed for 14 days following dosing.

RESULTS

Endpoint value(s): LD50 = 262 mg/kg-bw (male and female combined)

Results remarks: Clinical signs of toxicity included sluggishness, lacrimation, diarrhea and 

brown stains on the periurogenital fur and emaciation. Deaths occurred at 1 to 4 days. Survivors 

recovered at 2 to 5 days. Discolored, hemorrhaged stomachs, red to brown intestines, dark livers 

and fluid-filled thoracic cavities were mainly seen during necropsy of rats that died. No 
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remarkable gross lesions were seen during necropsy of survivors.

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid

REFERENCE

EPA-HQ-OPP-2006-0338

MRID 41394404
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Study 3: Acute oral toxicity study of DDAC in rats

Title: Acute oral toxicity

The study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: Purity 80%

METHOD

Method/guideline followed: 870.1100

Test type: Acute oral toxicity

GLP compliant?: Not stated

Year study performed: Not stated

Species/Strain: Rats, strain not specified

Number of animals/sex/dose: 5/sex

Route of administration: Gavage

Vehicle: Not stated

Doses/concentrations tested: 100, 200, 300 or 500 mg/kg-bw

Statistical methods used: Not stated

Test method/conditions remarks: Animals were administered the test substance via gavage and 

observed for 14 days following dosing.

RESULTS

Endpoint value(s): LD50 = 238 mg/kg-bw (male and female combined)

Results remarks: The major clinical signs during the observation period included urine and 

fecal stains, saliva discharge and stains, dried red stains on muzzle and around the eyes, eye 

squinting, piloerection, ataxia, body tremors, labored and shallow respiration, slight to severe 

depression, viscous red blood-like discharge from the mouth, bloated appearance to the abdomen 

and spasms in the abdominal area. With the exception of one animal, all animals that survived 
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the observation period exhibited no gross pathologic findings during necropsy.

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid

REFERENCE

EPA-HQ-OPP-2006-0338

MRID 42296101
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Study 4: Acute inhalation toxicity study of DDAC in rats

Title: Acute inhalation toxicity

The study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: 50% pure

METHOD

Method/guideline followed: 870.1300

Test type: Acute inhalation toxicity

GLP compliant?: Not stated

Year study performed: Not stated

Species/Strain: Rats, strain not specified

Number of animals/sex/dose: 5/sex

Route of administration: Inhalation

Vehicle: Not stated

Doses/concentrations tested: 0.05, 0.09, 0.13, 0.25 or 4.54 mg/L for 4 hours or 1.36 mg/L for 2 

hours

Statistical methods used: Not stated

Test method/conditions remarks: Animals were administered the test substance via inhalation

and observed for 14 days following dosing.

RESULTS

Endpoint value(s): LC50 = 0.07 mg/L (male and female combined)

Results remarks: At necropsy, no gross lesions were observed in 48 of the 60 test rats. 

Abnormalities of the liver, ear, skin, urinary bladder, kidneys, stomach, intestine, cecum, and 

lungs were noted.
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CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid

REFERENCE

EPA-HQ-OPP-2006-0338

MRID 00145074

TRID 455201010
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Study 5: Acute dermal toxicity study of DDAC in rabbits

Title: Acute inhalation toxicity

The study is: Adequate Not Adequate

TEST SUBSTANCE 

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: 65% pure

METHOD

Method/guideline followed: 870.1200

Test type: Acute dermal toxicity

GLP compliant?: Not stated

Year study performed: Not stated

Species/Strain: Rabbits, strain not specified

Number of animals/sex/dose: 5/sex

Route of administration: Dermal

Vehicle: Not stated

Doses/concentrations tested: 2000, 2830 or 4000 mg/kg-bw

Statistical methods used: Not stated

Test method/conditions remarks: Animals were administered the test substance via the dermal 

route and observed for 14 days following dosing.

RESULTS

Endpoint value(s): LD50 = 2930 mg/L (male and female combined)

Results remarks: Four rabbits died within 3 to 3.5 hours; most deaths occurred at 2 to 7 days. 

Skin reactions included erythema, edema, necrosis, ulceration, ecchymoses, fissuring, alopecia, 

desquamation, and scabs. Signs of systemic toxicity were sluggishness, prostration, diarrhea, and 

persistent weight loss (with emaciation in some animals). Necropsy revealed dark red lungs, 

hemorrhaged intestines, gas or liquid-filled intestines, dark purple thymus, and purple and 
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enlarged kidneys. Gross lesions at necropsy of survivors included dark red lungs, enlarged 

spleen, tan or purple kidneys, an excessive amount of blood in the kidneys, and a trace amount of 

blood in the urine).

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid

REFERENCE

EPA-HQ-OPP-2006-0338

MRID 42053801
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B-5. Dermal Irritation

Study 1: Dermal irritation study of DDAC in rabbits

Title: Mammalian Toxicity

TEST SUBSTANCE

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: 80% pure

METHOD

Method/guideline followed: 870.2500

GLP (Y/N): Not stated

Year: Not stated

Species/strain: Rabbits

Sex (male/female/both): Male

Number of animals/sex/dose: Single animal

Dose/concentration: Not stated

Test condition: One male rabbit was administered the test substance (80% purity) dermally for 4 

hours. 

RESULTS

Signs of severe irritation persisted 24 hours following application. Changes noted in the 

coloration and/or texture of the skin included coriaceousness, blanching, green-brown 

discoloration, brown/dark red discoloration, and necrosis. Due to the evidence of corrosion 

exhibited in this animal at the 24-hour reading, this study was terminated without testing 

additional animals.

CONCLUSIONS

Test substance is corrosive to rabbit skin. Toxicity Category I.
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RELIABILITY CODE

[1] - Valid

REFERENCE

EPA-HQ-OPP-2006-0338

MRID 42161601
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B-6. Eye Irritation

Study 1: Eye irritation study of DDAC in rabbits

Title: Mammalian Toxicity

TEST SUBSTANCE

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: 80% pure

METHOD

Method/guideline followed: 870.2400

GLP (Y/N): Not stated

Year: Not stated

Species/strain: Rabbits

Sex (male/female/both): Male

Number of animals/sex/dose: Single animal

Dose/concentration: Not stated

Test condition: One male rabbit was instilled the test substance (80%) into the eye for 1 hour. 

RESULTS

The total irritation score for the single animal was 94 out of 110 maximum at the one-hour 

interval. The test material produced extreme corneal opacity, iritis and conjunctival irritation 

after 1 hour. The eye of this animal also appeared misshapen. Due to the evidence of corrosion 

exhibited in this single animal, the study was terminated following the 1-hour reading without 

testing additional animals.

CONCLUSIONS

Test substance is corrosive to rabbit eyes. Toxicity Category I.

RELIABILITY CODE

[1] - Valid
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REFERENCE

EPA-HQ-OPP-2006-0338

MRID 42161602
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B-4. SKIN SENSITIZATION

Study 1: Skin sensitization study in guinea pigs

Title: Mammalian Toxicity

TEST SUBSTANCE

Identity: X-Cide 370 Industrial Biocide. 

Remarks: Test substance is 36% oxydiethylene bis (coco alkyl dimethyl ammonium chloride) 

and ~ 33% methanol.

METHOD

Method/guideline followed: Not stated

GLP (Y/N): Not stated

Year: Not stated

Species/strain: Guinea pigs

Sex (male/female/both): Not stated

Number of animals/sex/dose: Not stated

Dose/concentration: Not stated

Test condition: None stated

RESULTS

The test substance was found not to cause dermal sensitization in the guinea pig.

CONCLUSIONS

Not a dermal sensitizer.

RELIABILITY CODE

[4] – Not assignable
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REFERENCES

TSCATS submission (OTS0533639, Doc ID 88-910000287, received 09/25/91): Petrolite Corp. 

1991. Follow-up information from Petrolite Corporation to USEPA submitting enclosed data 

concerning oxydiethylene bis(alkyl dimethyl ammonium chloride) with attachments.
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Study 2: Dermal sensitization study of DDAC in guinea pigs

Title: Mammalian Toxicity

TEST SUBSTANCE

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: 80% pure

METHOD

Method/guideline followed: 870.2600

GLP (Y/N): Not stated

Year: Not stated

Species/strain: Guinea pigs

Sex (male/female/both): Not stated

Number of animals/sex/dose: 20 guinea pigs / dose

Dose/concentration: 0.25, 0.5 or 0.75% w/w (induction); 0.1% (challenge)

Test condition: Guinea pigs (20/dose) were administered the test substance (80% purity) at 0.25, 

0.5 or 0.75% w/w once a week for 3 weeks during induction phase. The challenge dose was 

0.1% over 27 days. A control group of 10 guinea pigs, not induced, received challenge dose of 

0.1% w/w. 

RESULTS

Erythema scores ranged from 0.05 to 0.10 in the test animals and from 0.05 to 0.20 in the 

controls. A positive response was not observed in any of the test or control animals.

CONCLUSIONS

Not a dermal sensitizer.

RELIABILITY CODE

[1] - Valid
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REFERENCES

EPA-HQ-OPP-2006-0338

MRID 46367601
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B-5. REPEATED DOSE TOXICITY STUDY

Summary of endpoint: Adequate

Study 1: Repeated-dose toxicity study of DDAC in rats

Title: Mammalian Toxicity

The study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: 80.8% pure

METHOD

Method/guideline followed: OPPTS 870.3100

GLP: Not stated

Year study was performed: Not stated

Test type: Subchronic toxicity test

Species/strain: Rats (strain not specified)

Sex: Both; 10/sex/group

Route of administration: Diet

Doses: 0, 6.2, 18.5, 36.8, 60.7 and 175.4 mg/kg-bw/day for males; 0, 7.5, 22.3, 44.4, 74.3 or 

225.5 mg/kg-bw/day for females

Exposure period: 13 weeks

Frequency of treatment: Daily

Control group and treatment: Control was included (0 mg/kg-bw/day)

Post-observation period: Not stated

Statistical methods: Not stated
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Method remarks: Rats (10/sex/dose) were administered the test substance (80.8% purity) via 

the diet at 0, 6.2, 18.5, 36.8, 60.7 and 175.4 mg/kg-bw/day for males and 0, 7.5, 22.3, 44.4, 74.3 

and 225.5 mg/kg-bw/day for females for 13 weeks.

RESULTS

NOAEL and LOAEL: 

LOAEL (males) = 175.4 mg/kg-bw/day (based on increased mortality and effects on body 

weights, liver and spleen) 

NOAEL (males) = 60.7 mg/kg-bw/day 

LOAEL (females) = 225.5 mg/kg-bw/day (based on increased mortality and effects on body 

weight, liver, spleen and lymph nodes) 

NOAEL (females) = 74.3 mg/kg-bw/day

Remarks: High-dose animals showed increased mortality, decreased mean body weights, body 

weight gain and food consumption and an increased incidence of gross pathological observations 

and non-neoplastic lesions, including higher incidence of glycogen depletion in the liver and 

contracted spleens. Additionally, high-dose females showed sinus erythrocytosis and lymphoid 

hyperplasia of mesenteric lymph nodes.

CONCLUSIONS

None stated

RELIABILITY CODE

[1] Valid

REFERENCES

EPA-HQ-OPP-2006-0338

MRID 40966302
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Study 2: Repeated-dose toxicity study of DDAC in rats

Title: Mammalian Toxicity

The study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: 80.8% pure

METHOD

Method/guideline followed: OPPTS 870.3250

GLP: Not stated

Year study was performed: Not stated

Test type: Subchronic dermal toxicity test

Species/strain: Sprague-Dawley rats

Sex: Both; 15/sex/group

Route of administration: Dermal

Doses: 0, 2, 6 or 12 mg/kg-bw/day 

Exposure period: 13 weeks

Frequency of treatment: 6 hours/day, 5 days/week

Control group and treatment: Control was included (0 mg/kg-bw/day)

Post-observation period: Not stated

Statistical methods: Not stated

Method remarks: Sprague-Dawley rats (15/sex/dose) were administered the test substance 

(80.8% purity) dermally at 0, 2, 6 and 12 mg/kg-bw/day for 6 hours/day, 5 days/week for 13 

weeks.
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RESULTS

NOAEL and LOAEL: 

NOAEL = 12 mg/kg-bw/day (based on no systemic toxicity at the highest dose tested) 

LOAEL = 6 mg/kg-bw/day (based on skin effects) 

NOAEL = 2 mg/kg-bw/day

Remarks: Treatment-related toxicity was limited to treated skin of 6 mg/kg-bw/day females and 

12 mg/kg-bw/day males and females. The clinical and gross findings (erythema, edema, 

exfoliation, excoriation and ulceration) were confirmed by histopathological examination, where 

increased incidence of hyperkeratosis, acanthosis, dermatitis and ulceration were noted 

beginning after 5 days of exposure. No treatment-related effects were noticed in mortality, 

weight gain, food consumption or systemic toxicity.

CONCLUSIONS

None stated

RELIABILITY CODE

[1] Valid

REFERENCES

EPA-HQ-OPP-2006-0338

MRID 41305901
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Study 3: Repeated-dose toxicity study of DDAC in mice

Title: Mammalian Toxicity

The study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: 80.8% pure

METHOD

Method/guideline followed: OPPTS 870.4300

GLP: Not stated

Year study was performed: Not stated

Test type: Combined Chronic/Carcinogenicity (oral) - mouse

Species/strain: CD-1 mice

Sex: Both; 60/sex/group

Route of administration: Diet

Doses: 0, 100, 500 or 1000 ppm (approximately 0, 15.0, 76.3 or 155.5 mg/kg-bw-day for males 

and 0, 18.6, 93.1 or 193.1 mg/kg-bw/day for females)

Exposure period: 78 weeks

Frequency of treatment: Daily

Control group and treatment: Control was included (0 mg/kg-bw/day)

Post-observation period: Not stated

Statistical methods: Not stated

Method remarks: CD-1 mice (60/sex/dose) were administered the test substance (80.8% 

purity) via the diet at 0, 100, 500 or 1000 ppm (approximately 0, 15.0, 76.3 or 155.5 mg/kg-bwday for males and 0, 18.6, 93.1 or 193.1 mg/kg-bw/day for females) for 78 weeks. 
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RESULTS

NOAEL and LOAEL: 

LOAEL = 155.5/193.1 mg/kg-bw/day (males/females, based on decreased in mean body 

weights and body weight gains) 

NOAEL = 76.3/93.1 mg/kg-bw/day (males/females)

Remarks: Treatment-related effects were decreased mean body weights and body weight gains. 

No treatment-related effects were noted in the incidence of clinical signs, deaths, gross and 

histopathological observations. Hematological values were comparable among all study groups.

CONCLUSIONS

None stated

RELIABILITY CODE

[1] Valid

REFERENCES

EPA-HQ-OPP-2006-0338

MRID 41802301
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Study 4: Repeated-dose toxicity study of DDAC in dogs

Title: Mammalian Toxicity

The study is: Adequate Not Adequate

This study is not adequate for the repeated-dose endpoint as dogs are not a preferred species for 

testing.

TEST SUBSTANCE

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: None stated

METHOD

Method/guideline followed: OPPTS 870.3150

GLP: Not stated

Year study was performed: Not stated

Test type: Subchronic (oral) toxicity - dog

Species/strain: Beagle dogs

Sex: Both; 4/sex/dose

Route of administration: Diet

Doses: 0, 5, 15 or 50 mg/kg-bw/day

Exposure period: 90 days

Frequency of treatment: Daily

Control group and treatment: Control was included (0 mg/kg-bw/day)

Post-observation period: Not stated

Statistical methods: Not stated

Method remarks: Beagle dogs (4/sex/dose) were administered the test substance in the diet at 

0, 5, 15 or 50 mg/kg-bw/day for 90 days. 
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RESULTS

NOAEL and LOAEL: 

LOAEL = 50 mg/kg-bw/day (based on decreased body weight gain, food consumption, and 

food efficiency) 

NOAEL = 15 mg/kg-bw/day

Remarks: High-dose males and females experienced marked decrease in body weight gain, food 

consumption, and food efficiency.

CONCLUSIONS

None stated

RELIABILITY CODE

[3] Not reliable – testing performed on a species that is not preferred.

REFERENCES

EPA-HQ-OPP-2006-0338

MRID 40262901
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Study 5: Repeated-dose toxicity study of DDAC in dogs

Summary of endpoint: Adequate

Title: Mammalian Toxicity

The study is: Adequate Not Adequate

This study is not adequate for the repeated-dose toxicity endpoint as dogs are not a preferred 

species for testing.

TEST SUBSTANCE

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: 80.8% pure

METHOD

Method/guideline followed: OPPTS 870.4100

GLP: Not stated

Year study was performed: Not stated

Test type: Chronic toxicity (oral feed) - dog

Species/strain: Beagle dogs

Sex: Both; 4/sex/dose

Route of administration: Diet

Doses: 0, 3, 10, or 20/30 mg/kg-bw/day

Exposure period: 1 year

Frequency of treatment: Daily

Control group and treatment: Control was included (0 mg/kg-bw/day)

Post-observation period: Not stated

Statistical methods: Not stated
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Method remarks: Beagle dogs (4/sex/dose) were administered the test substance (80.8% 

purity) orally at 0, 3, 10, or 20/30 mg/kg-bw/day for 1 year. A dose of 30 mg/kg-bw/day was not 

well tolerated and was discontinued on day 31, dosing was resumed on day 36 at 20 mg/kgbw/day.

RESULTS

NOAEL and LOAEL: 

LOAEL = 20 mg/kg-bw/day (based on decreased total cholesterol levels) 

NOEAL = 10 mg/kg-bw/day

Remarks: No treatment-related deaths occurred during the study. The treatment-related clinical 

signs (soft/mucoid feces, emesis) were observed frequently in high-dose animals. Hematology or 

urinalysis results were normal. Total cholesterol levels were significantly decreased in the highdose females. Gross and histopathological findings did not reveal any treatment-related effects. 

EPA’s OPP established a LOAEL of 20 mg/kg-bw/day based decreased total cholesterol levels 

in females and a NOAEL of 10 mg/kg-bw/day.

CONCLUSIONS

None stated

RELIABILITY CODE

[3] Not reliable – testing performed on a species that is not preferred.

REFERENCES

EPA-HQ-OPP-2006-0338

MRID 40262901
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B-6. GENETIC TOXICITY STUDIES

Summary of endpoint: Adequate

Study 1: Bacteria reverse mutation assay 

Title: Genetic Toxicity

The study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: 50% pure

METHOD

Method/guideline followed: 870.5100

Test Type: Bacteria reverse mutation assay

Test system: Bacteria, in vitro

GLP (Y/N): Not stated

Year study performed: Not stated

Species/Strain/cell-type/cell line: S. typhimurium strains TA98, TA100, TA1535, TA1537 and 

TA1538 were exposed to the test substance at concentrations ranging from of test substance, in 

the presence and absence of metabolic activation. 

Metabolic activation: With and without

Concentrations tested: 3.9 to 1000 μg/plate

Remarks: None

RESULTS

Overall results: Negative

Cytotoxic concentration: Cytotoxic concentrations were > 65.5 μg/plate without metabolic 

activation and at 125 or 250 μg/plate with metabolic activation.

Remarks: Not mutagenic. Positive control responded appropriately.
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CONCLUSIONS

ADBAC showed negative evidence of mutagenicity in Chinese Hamster ovary cells.

RELIABILITY CODE

[1] – Valid

REFERENCE

EPA-HQ-OPP-2006-0338

MRID 40282201
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Study 2: Mammalian cell forward gene mutation assay 

Title: Genetic Toxicity

The study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: 80% pure

METHOD

Method/guideline followed: 870.5300

Test Type: Mammalian cell forward mutation assay

Test system: Chinese hamster ovary (CHO) cells, in vitro

GLP (Y/N): Not stated

Year study performed: Not stated

Species/Strain/cell-type/cell line: Chinese hamster ovary cells

Metabolic activation: With and without

Concentrations tested: 10 doses, ranging from 1.0 to 13.0 μg/mLwithout activation; doses 

ranging from 1.0 to 4.0 μg/mL with activation.

Remarks: Vehicle control of deionized water

RESULTS

Overall results: Negative

Cytotoxic concentration: None stated

Remarks: Acceptable response from positive and negative controls

CONCLUSIONS

Not genotoxic.
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RELIABILITY CODE

[1] - Valid

REFERENCE

EPA-HQ-OPP-2006-0338

MRID 93014008
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B-7. CHROMOSOMAL ABERRATIONS STUDIES

Summary of endpoint: Adequate

Study 1: Mammalian chromosome aberration test

Title: Genetic Toxicity

The study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: DDAC

Remarks: 80% purity

METHOD

Method/guideline followed: 870.5375

Test Type: In vitro mammalian chromosome aberration test

Test system: In vitro

GLP (Y/N): Not stated

Year study performed: Not stated

Species/Strain/cell-type/cell line: Chinese hamster ovary (CHO) cells

Metabolic activation: With and without

Concentrations tested: 0, 2, 4, 8 or 16 μg/mL with metabolic activation for 6 hours; 0, 1, 2, 4 or 

8 μg/mL without metabolic activation for 24 hours

Remarks: 

None stated

RESULTS

Overall results: Negative

Cytotoxic concentration: Not stated

Remarks: Positive and negative controls responded appropriately
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CONCLUSIONS

Did not induce chromosomal aberrations

RELIABILITY CODE

[1] - Valid

REFERENCE

EPA-HQ-OPP-2006-0338

MRID 41252601
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Study 2: Unscheduled DNA synthesis assay

Title: Genetic Toxicity

The study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: DDAC

Remarks: 80% purity

METHOD

Method/guideline followed: 870.5550

Test Type: Unscheduled DNA synthesis assay

Test system: In vivo

GLP (Y/N): Not stated

Year study performed: Not stated

Species/Strain/cell-type/cell line: Rat hepatocytes

Metabolic activation: Not stated

Concentrations tested: Ranging from 0.050 to 10.0 μg/mL

Remarks: 

None stated

RESULTS

Overall results: Negative

Cytotoxic concentration: Not stated

Remarks: The test material was lethal at concentrations exceeding

4.00 μg/mL and excessively toxic at 4.00 μg/mL.

Moderately high toxicity was observed at 2.00 μg/mL

(74.6% survival), however normal cellular morphology

was observed and analysis could be performed.
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CONCLUSIONS

Did not induce UDS

RELIABILITY CODE

[1] - Valid

REFERENCE

EPA-HQ-OPP-2006-0338

MRID 93014007
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B-7. REPRODUCTIVE TOXICITY STUDY

Summary of endpoint: Adequate

Study 1: Reproductive toxicity study of DDAC in rats

Title: Mammalian Toxicity 

The study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: 80.8% pure

METHOD

Method/guideline followed: 870.3800

GLP: No

Year study was performed: Not stated

Species/strain: Sprague-Dawley rats

Sex: Both

Route of administration: Diet 

Doses: 0, 300, 750 and 1500 ppm (0, 20, 50 or 103 mg/kg-bw/day for males and 0, 24, 61 or 122 

mg/kg-bw/day for females, respectively)

Exposure period: Not stated

Frequency of treatment: Daily

Control group and treatment: 0 mg/kg/day 

Post-observation period: Not stated

Statistical methods: Not stated
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Method remarks: In a two-generation reproductive study, Sprague-Dawley rats (28/sex/dose) 

were administered the test substance (80.8% purity.) in the diet at 0, 300, 750 and 1500 ppm (0, 

20, 50 or 103 mg/kg-bw/day for males and 0, 24, 61 or 122 mg/kg-bw/day for females, 

respectively). 

RESULTS

NOAEL and LOAEL: 

LOAEL (parental toxicity) = ~ 113 mg/kg-bw/day (1500 ppm) (based on decreased body 

weight, weight gain and food consumption) 

NOAEL (parental toxicity) = ~ 56 mg/kg-bw/day (750 ppm) 

NOAEL (reproductive toxicity) = 113 mg/kg-bw/day (1500 ppm) (based on no effects at the 

highest dose tested) 

LOAEL (offspring toxicity) = ~ 113 mg/kg-bw/day (1500 ppm) (based on decreased body 

weights) 

NOAEL (offspring toxicity) = ~ 56 mg/kg-bw/day (750 ppm)

Remarks: No adverse reproductive effects were observed at any dose. Parental toxicity observed 

at 1500 ppm (113 mg/kg-bw/day) was limited to body weight reduction, weight gain depression 

and decreased food consumption. Postnatal toxicity seen at 1500 ppm (113 mg/kg-bw/day) was 

reduced pup body weights.

CONCLUSIONS

None stated

RELIABILITY CODE

[1] - Valid

REFERENCES

EPA-HQ-OPP-2006-0338

MRID 418045-01
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B-8. DEVELOPMENTAL TOXICITY STUDIES

Summary of endpoint: Adequate

Study 1: Developmental toxicity study of DDAC in rabbits

Title: Mammalian Toxicity

The study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: 80.8% pure

METHOD

Method/guideline followed: 870.3700

GLP: Not stated

Year study was performed: Not stated

Species/strain: New Zealand rabbits 

Sex: Female; 16/group

Route of administration: Gavage

Doses: 0, 1, 3 and 10 mg/kg/day

Exposure period: on gestation days 6 through 18

Frequency of treatment: Daily

Control group and treatment: a control was included (0 mg/kg-bw/day)

Post-observation period: Not stated

Statistical methods: Not stated

Method remarks: Pregnant New Zealand White rabbits (16/dose) were administered the test 

substance (80.8% purity.) via gavage at 0, 1, 3 and 10 mg/kg-bw/day on days 6–18 of gestation. 
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RESULTS

NOAEL and LOAEL: 

LOAEL (maternal toxicity) = 3 mg/kg-bw/day (based on reductions in body weight gain, 

hypoactivity, labored/audible respiration and mortality) 

NOAEL (maternal toxicity) = 1 mg/kg-bw/day 

LOAEL (developmental toxicity) = 10 mg/kg-bw/day (based on increased mortality, decreased 

fetal body weight and an increased number of dead fetuses) 

NOAEL (developmental toxicity) = 3 mg/kg-bw/day

Remarks: Maternal toxicity was evident at the mid and high doses and was seen as hypoactivity, 

labored and/or audible respiration and decreased body weight gain during the dosing period. At 

10.0 mg/kg-bw/day, there was an increased incidence of mortality. Developmental effects 

included increased incidence of fetal mortality and reduced fetal body weight per litter at 10.0 

mg/kg-bw/day.

CONCLUSIONS

None stated

RELIABILITY CODE

[1] - Valid

REFERENCES

EPA-HQ-OPP-2006-0338

MRID 410187-01
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Study 2: Developmental toxicity study of DDAC in rats

Title: Mammalian Toxicity

The study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173-51-5)

Remarks: 80.8% pure

METHOD

Method/guideline followed: 870.3700

GLP: Not stated

Year study was performed: Not stated

Species/strain: Sprague-Dawley rats 

Sex: Female; 25/group

Route of administration: In deionized water via gavage

Doses: 0, 1, 10 or 20 mg/kg/day

Exposure period: on gestation days 6 through 15

Frequency of treatment: Daily

Control group and treatment: a control was included (0 mg/kg-bw/day)

Post-observation period: Not stated

Statistical methods: Not stated

Method remarks: Pregnant Sprague-Dawley rats (25/dose) were administered the test substance 

(80.8% purity) via gavage at 0, 1, 10 and 20 mg/kg-bw/day on days 6–15 of gestation. 
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RESULTS

NOAEL and LOAEL: 

LOAEL (maternal toxicity) = 10 mg/kg-bw/day (based on decreased body weight gain, low 

food efficiency and audible respiration) 

NOAEL (maternal toxicity) = 1 mg/kg-bw/day 

LOAEL (developmental toxicity) = 20 mg/kg-bw/day (based on an increased incidence of 

skeletal variations) 

NOAEL (developmental toxicity) = 10 mg/kg-bw/day

Remarks: Treatment-related maternal effects observed at 10 and 20 mg/kg-bw/day were of 

audible respiration and low food efficiency. Treatment-related decreases in body weight gain and 

corrected body weight gain were also observed at the high dose during gestation and for several 

days after the dosing period. Treatment-related developmental effects at the high dose were 

increased incidences of skeletal variations (split anterior arch of the atlas, poorly ossified 

thoracic centrum, bilobed thoracic centrum, unilateral short rib, poorly ossified parietal, and 

poorly ossified sternebrae).

CONCLUSIONS

None stated

RELIABILITY CODE

[1] - Valid

REFERENCES

EPA-HQ-OPP-2006-0338

MRID 41886701
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B-9. CARCINOGENICITY STUDIES

Study 1: Carcinogenicity study of DDAC in rats

Title: Mammalian Toxicity

The study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: DDAC

Remarks: 80.8% purity

METHOD

Method/guideline followed: 870.4300

GLP: Not stated

Year study was performed: Not stated

Test type: Carcinogenicity

Species/strain: Sprague-Dawley CD rats

Sex: 60/sex/dose

Route of administration: Diet 

Doses: 0, 300, 750 or 1500 ppm (approximately 0, 13, 32 or 64 mg/kg-bw/day, respectively, for 

males and 0, 16, 41 or 83 mg/kg-bw/day, respectively, for females)

Exposure period: 2 years

Frequency of treatment: Daily

Control group and treatment: 0 mg/kg/day

Post-observation period: Not stated

Statistical methods: Not stated

Method remarks: In a combined chronic toxicity/carcinogenicity study, Sprague-Dawley CD 

rats (60/sex/dose) were administered the test substance (80.8% purity.) in the diet at 0, 300, 750 
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or 1500 ppm (approximately 0, 13, 32 or 64 mg/kg-bw/day, respectively, for males and 0, 16, 41 

or 83 mg/kg-bw/day, respectively, for females) for 2 years. 

RESULTS

NOAEL and LOAEL: 

The NOEL for both sexes is 750 ppm. The LOEL for both sexes is 1500 ppm, based on

increased incidence of nonneoplastic lesions in the mesenteric lymph nodes.

Actual dose received by dose level by sex: Not stated

Remarks: High-dose animals showed slight (<10%) but statistically significant decreases in 

mean body weight during the study. Treatment-related effects included increased incidence of 

sinusoidal blood, hemosiderosis and histiocytosis in the mesenteric lymph nodes in high dose 

animals. In addition, a treatment-related increase in the incidence of interstitial cell adenomas in 

testes was reported, but the incidences were within the historical incidence range. The maximum 

tolerated dose was achieved in this study for carcinogenicity testing based on slight but 

statistically significant decrease in mean body weight (<10%) and some histopathological 

changes. There was no other evidence of carcinogenicity in this study.

CONCLUSIONS

None stated

RELIABILITY CODE

[1] - Valid

REFERENCES

EPA-HQ-OPP-2006-0338

MRID 41965101
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Study 2: Carcinogenicity study of DDAC in mice

Title: Mammalian Toxicity

The study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: DDAC

Remarks: 80.8% purity

METHOD

Method/guideline followed: 870.4300

GLP: Not stated

Year study was performed: Not stated

Test type: Carcinogenicity

Species/strain: CD-1 mice

Sex: 60/sex/dose

Route of administration: Diet 

Doses: 0, 100, 500 or 1000 ppm (approximately 0, 15.0, 76.3 or 155.5 mg/kg-bw/day, 

respectively, for males and 0, 18.6, 93.1 or 193.1 mg/kg-bw/day, respectively, for females)

Exposure period: 78 weeks

Frequency of treatment: Daily

Control group and treatment: 0 mg/kg/day

Post-observation period: Not stated

Statistical methods: Not stated

Method remarks: In a carcinogenicity study, CD-1 mice (60/sex/dose) were administered the 

test substance in the diet (80.8% purity.) at 0, 100, 500 or 1000 ppm (approximately 0, 15.0, 76.3 

or 155.5 mg/kg-bw/day, respectively, for males and 0, 18.6, 93.1 or 193.1 mg/kg-bw/day, 

respectively, for females) for 78 weeks. 
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RESULTS

NOAEL and LOAEL: 

The NOAEL for both male and females is 500 ppm (76.3 mg/kg/day for males and 93.1

mg/kg/day for females), and the LOAEL is1500ppm (155.5 mg/kg/day for males; 193.1

mg/kg/day for females). The LOAEL is based on decreases in mean body weights and body

weight gains.

Actual dose received by dose level by sex: Not stated

Remarks: No treatment-related mortality or clinical signs, gross and histopathological 

observations were observed. Hematological values were comparable among all study groups. 

There was no evidence of carcinogenicity in this study.

CONCLUSIONS

DDAC was not carcinogenetic at this level

RELIABILITY CODE

[1] - Valid

REFERENCES

EPA-HQ-OPP-2006-0338MRID 41802301
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CAS No. 68607-28-3: Summary of Endpoints

Endpoint Study Information 

Provided

Acceptable Data Gap

Aquatic Effects

Acute Toxicity to Fish Yes Yes No

Acute Toxicity to Daphnia Yes Yes No

Toxicity to Aquatic Plants Yes Yes No

Health Effects

Acute Toxicity Yes Yes No

Repeated-Dose Toxicity Yes Yes No

Genetic Mutation Yes Yes No

Chromosomal Aberrations Yes Yes No

Toxicity to Reproduction Yes Yes No

Developmental Toxicity Yes Yes No