SRC TR

- 10

- 121

HPV4 CHEMICAL DATA A DEQUACY 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 a nd 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

El izabeth Margosches, Alternate Project Officer

Meena Sonawane, Work Assignment Manager

David Brooks, Alternate Work Assignment Manager

July 13 , 2010HPV4 Chemical Data Adequacy Review

Quaternary ammonium compounds, (oxydi

- 2,1

- ethanediyl)bis[coco alkyld imethyl,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

Prep ared By:

SRC, Inc.

Environmental Science Center

2451 Crystal Drive, Suite 804

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

- 28

- 3

1 A. PREPARATION OF THE DATA ADEQUACY ASSESSMENTS

A

- 1. Source material used f or 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, d ermal, 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

- B ibliographic database that contains references to journal articles in the life

sciences with a concentration on biomedicine

T OXNET

- N ational L ibrary of M edicine 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 I nformation System (CCRIS)

- Carcinogenicity and mutagenicity test results for over 8000

**•** chemicals) ;

**•** Hazardous Substances Data Bank (HSDB)

- Comprehensive, peer

reviewed toxicology data for about 5000 chemicals ;

**•** Genetic Toxicology Data Bank (GENE

- TOX)

- Peer

- reviewed genetic

toxicology test data for over 3000 chemicals.

TSCATS

- U npublished technical reports submitted by industry to the EPA under the

Toxic Substances Control Act]

Registry of toxic effects of chemical substances (RTECs)

Environmental Fa te Database (EFDB)

ECOTOX

- EPA’s peer

- reviewed ecotoxicology databaseDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

2 EPA’s Integrated Risk Information System (IRIS) website

Agency for Toxic Substances and Disease Registry (ATSDR) website

National Toxicology Program (NTP) website

International Prog ram on Chemical Safety Concise International Chemical Assessment

Documents (IPCS INC HE M 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 D ataset s sometimes contained studies of interest, cert ain study

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

of the study, if available and accessible, was obtain ed and review ed.

A

- 2. Evaluating data adequacy

Using standard OECD testing guidelines an d 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 accordin g 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

w as 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 T HE 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 o f 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

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

bonded to two alkyl group substituents (at least one C 8 or longer) and two methyl substituents.

In finished form, these quats are salts with a positively charged nitro gen (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

3 Both q uaternary ammonium compounds, (oxydi

- 2,1

- ethanediyl)bis[coco alkyldimethyl,

dichlorides (CAS No. 68607

- 28

- 3) and dide cyldimethylammonium chloride (DDAC, CAS No.

7173

- 51

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

T he close structural relationship between q uaternary 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

4 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 ammo nium 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 stat ed

Exposure duration: Not stated

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC 50 = 0.46 mg/L (nominal)

Results remarks: None stated

CONCLUSIONSDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

5 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 ox ydiethylene bis(alkyl dimethyl ammonium chloride) with attachments.Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

6 Title: Aquatic Toxicity

Study 2: Acute toxicity study in fathead minnow

This study is: Adequate Not Adequate

This study is not adequate due to la ck 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

T est 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): LC 50 = 0.42 mg/L (nominal)

Results remarks: None stated

CONCLUSIONS

None statedDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

7 STUDY RELIABILITY

[3] Not reliable

– lack of study details and use of mixture

REFERENCE

TSCATS submission (OTS0533639, Doc ID 88

- 91000028 7, 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 attachmentsDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

8 Study 3: Acute toxicity study i n fathead minn ow

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 subs tance 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

An alytical 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): LC 50 = 4.0 mg/L (n ominal)

Results remarks: None stated

CONCLUSIONS

None statedDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

9 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. Fol low

- up information from Petrolite Corporation to USEPA submitting enclosed data

concerning oxydiethylene bis(alkyl dimethyl ammonium chloride) with attachmentsDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

10 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 dimet hyl 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 durati on: 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): LC 50 = 13.4 mg/L (nominal)

Results remarks: None stated

CONCLUSIONS

None statedDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

11 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 su bmitting enclosed data

concerning oxydiethylene bis(alkyl dimethyl ammonium chloride) with attachmentsDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

12 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 d imethyl 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 du ration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC 50 = 0.40 mg/L (nominal)

Results remarks: None stated

CONCLUSIONS

None statedDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

13 STUDY RELIABILITY

[3] Not reliable

– lack o f 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 en closed data

concerning oxydiethylene bis(alkyl dimethyl ammonium chloride) with attachmentsDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

14 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 stat ed

RESULTS

Endpoint value(s): LC 50 = 1.2 mg/L (nominal)

Results remarks: None stated

CONCLUSIONS

None statedDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

15 STUDY RELIABILITY

[3] Not relia ble

– lack of study details and use of a mixture

REFERENCE

TSCATS submission (OTS0533639, Doc ID 88

- 91000 0287, 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 attachmentsDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

16 Study 7: Acute toxicity study in sheeps head 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: Sheepshea d minnow

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC 50 = 0.55 mg/L (nominal)

Results remarks: None stated

CONCLUSIONS

No ne statedDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

17 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 USE PA submitting enclosed data

concerning oxydiethylene bis(alkyl dimethyl ammonium chloride) with attachmentsDraft 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 Ade quate

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.

METHO D

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 state d

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

mg/L clay.

RESULTS

Endpoint value(s): LC 50 = 6.8 mg/L (nominal)

Results remarks: None stated

CONCLUSIONS

None statedDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

19 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 oxydiethyle ne bis(alkyl dimethyl ammonium chloride) with attachmentsDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

20 Study 9 : Aquatic t oxicity study of DDAC in bluegill sunfish

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: Did ecyldimethylammonium 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 macroc hirus

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC 50 = 0.32 mg/L (measured)

Results remarks: None stated

CONCLUSIONS

None stated

STUDY RELIABILITY

[2 ] Reliable with restrictionsDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

21 REFERENCE

LeLievre, M.k. 1990A

MRID#

- 41578001Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

22 Study 10 : Aquatic t oxicity study of DDAC in coho salmon

Title: Aquatic Toxicity

This study is: Adequate N ot 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): LC 50 = 1.0 mg/L (measured)

Result s remarks: None stated

CONCLUSIONS

None stated

STUDY RELIABILITY

[2 ] Reliable with restrictionsDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

23 REFERENCE

LeLievre, M.K. 1990b

MRID#

- 41578003Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

24 Study 11 : Aquatic t oxicity study of DDAC in rainbow trout

Title: Aquatic Toxicity

Th is 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 toxicit y

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): LC 50 = 478 mg/L

Results remarks: Practically non

- toxic

CONCLUSIONS

None stated

STUDY RELIABILITY

[ 1 ] ValidDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

25 REFERENCE

Rhodes, R.E. 2000a

MRID#

- 41592002Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

26 Study 12 : Aquatic t oxicity 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 stat ed

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC 50 = 188 mg/L

Results remarks: Practically non

- toxic

CONCLUSIONS

None stated

STUDY RELIABILITY

[1 ] ValidDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

27 REFERENCE

Rhodes, R.E. 2000b

MRID#

- 41592001Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

28 Study 13 : Aq uatic t oxicity 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 s tated

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: N ot stated

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC 50 = 0.96 mg/L

Results remarks: Highly toxic

CONCLUSIONS

None stated

STUDY RELIABILITY

[1 ] ValidDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

29 REFERENCE

Collins, M.K. 1994

MRID#

- 43620001Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

30 Study 14 : Aquatic t oxicity study of DDAC in bluegill sunfish

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: Didecyldimethylammonium chloride (DDAC; CA S 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: N ot stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: None stated

RESULTS

Endpoint value(s): LC 50 = 0.5 mg/L

Results remarks: Highly toxic

CONCLUSIONS

None stated

STUDY RELIABILITY

[1 ] ValidDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

31 R EFERENCE

Onyx Chemical Co. 1982a

PROJ#

- 038901Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

32 Study 15 : Aquatic t oxicity study of DDAC in rainbow trout

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: Didecyldimethy lammonium 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): LC 50 = 2.8 mg/L

Results remarks: Moderately toxic

CONCLUSIONS

None stated

STUD Y RELIABILITY

[1 ] ValidDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

33 REFERENCE

Onyx Chemical Co. 1982b

PROJ#

- 038901Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

34 Study 16 : Aquatic t oxicity 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): LC 50 = 1.6 mg/L

Results remarks: Moderately toxic

C ONCLUSIONS

None stated

STUDY RELIABILITY

[1 ] ValidDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

35 REFERENCE

Supremant D.C. 1986 ACC#

- 40129801Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

36 Study 17 : Aquatic t oxicity study of DDAC in bluegill sunfish

Title: Aquatic Toxicity

This study is: Adequate No t 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 st ated

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): LC 50 = 0.27 mg/L

Results remarks: None stated

CONCLUSIONS

None stated

STUDY RELIABILITY

[1 ] ValidDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

37 REFERENCE

Wells Labs 1971a

ACC#

- 007958Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

38 Study 18 : Aquatic t oxicity 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): LC 50 = 1.1 mg/L

Results remarks: None stated

CONCLUSIONS

None stated

STUDY RELIABILITY

[1 ] ValidDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

39 REFERENCE

Wells Labs 1971b

ACC#

- 007958Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

40 B

- 2. TOXICITY TO AQUATIC INVERTEBRATES

Summary of endpoint: Adequate

Study 1: Acute toxicity study in brown s hrimp

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

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

TEST SUBSTANCE

Identity: X

- Cide 370

Remarks: Test s ubstance 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 LC 50 = 34.0 mg/L (nominal)

Results remarks : None stated

CONCLUSIONSDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

41 Non e 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 US EPA submitting enclosed data

concerning oxydiethylene bis(alkyl dimethyl ammonium chloride) with attachmentsDraft 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 Adequa te

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 LC 50 = 4.0 mg/L (nominal)

Results remarks : None stated

CONCLUSIONS

None stated

STUDY RELIABILITYDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

43 [3] Not reliable

– lack of study details and testing on a mixture

REFERENC E

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 attachm entsDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

44 Study 3 : Acute toxicity study of DDAC in D aphnia magna

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173

- 51

- 5)

R emarks: 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

Concentrati ons 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] ValidDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

45 REFERENCE

Onyx Chemical Co. 1982c

PR OJ#

- 038901Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

46 Study 4 : Acute toxicity study of DDAC in D aphnia 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

Con centrations tested: Not stated

Test method/conditions remarks: Not stated

RESULTS

Endpoint value(s): The 48

- hour EC50 = 94 μ g/L

Results remarks : Very highly toxic

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] ValidDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

47 REFERENCE

LeLievre, M.K. 1990c

MRID#

- 41578002Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

48 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. 7 173

- 51

- 5)

Remarks: None s t ated

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] ValidDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

49 REFERENCE

Surp renant, E.C. 1987

ACC#

- 40129801, 02, 03Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

50 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 wit h restrictionsDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

51 REFERENCE

Roberts, S. 1977

No.

– 7E

- 6686Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

52 Study 7 : Acute toxicity study of DDAC in Daphnia magna

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: Didecyl dimethylammonium chloride (DDAC; CAS No. 7173

- 51

- 5)

Remarks: None s t ated

METHOD

Method/guideline followed: None stated

Test type: Static

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Daphnia magna

Analytical monitor ing: 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 ] ValidDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

53 REFERENCE

Canon Labs 1976

ACC#

- 225596Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

54 Study 8 : Acute toxicity study of DDAC in mysid shrimp

Title: Aquatic Toxicity

This study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: Didecyldimethyl ammonium chloride (DDAC; CAS No. 7173

- 51

- 5)

Remarks: None stat ed

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] ValidDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

55 REFERENCE

LeLievre, M. K. 1990d

MRID#

- 41578004Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

56 B

- 3 . TOXICITY TO AQUATIC PLANTS

Summary of endpoint: A d equate

Study 1: Acute toxicity of DDAC in Selenastrum capricornutum

Title: Aquatic Toxicity

This study is: Adequa te 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 E C 50 = 0.0732 mg/L

NOEC = 0.027 mg/L

Results remarks : None stated

CONCLUSIONS

None statedDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

57 STUDY RELIABILITY

[1]

- Valid

REFERENCE

Krueger, H.O. et al. 2003

MRID#

- 45896401Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

58 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 state d

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 r emarks: Using natural surface water

RESULTS

Endpoint value(s): The 96

- hour E C 50 = 0.01422 mg/L

NOEC = 0.008 mg/L

Results remarks : None stated

CONCLUSIONS

None stated

STUDY RELIABILITY

[1]

- ValidDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

59 REFERENCE

Krueger, H.O. et al. 2003

MRID#

- 45896401Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

60 B

- 4

. ACUTE TOXICITY

Summary of endpoint: A dequate

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 al kyl dimet h yl ammonium chloride)

and ~ 33% me thanol.

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 p erformed: 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 m g/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.Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

61 Three groups of ten (5 male & 5 female) rats were exposed to the test a rticle 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 thr ough 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 difficult ies 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 maintaine d 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 cal culated 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 duri ng 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 concent ration (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 fr om 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

collect ing 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 andDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

62 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 pe riod 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

reco rded 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 anim als.

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: Mor talities 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 tw o

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 1 2. 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 an d/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 wei ght 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 tiss ue (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.Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

63 A low percentage of submicron droplets was collected from the chamber. The size cut j ust

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 1.1μ m 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 f ilter. 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 conducte d on a mixture.

REFERENCE

TSCATS submission (OTS0 533639 , 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.Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

64 Study 2: Acute oral toxicity study of DDAC in rats

Title: Acute oral toxicity

The study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: Didecyl dimethylammonium 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

Nu mber 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 me thod/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 sl uggishness, 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 thor acic cavities were mainly seen during necropsy of rats that died. NoDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

65 remarkable gross lesions were seen during necropsy of survivors.

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid

REFERENCE

EPA

- HQ

- OPP

- 2006

- 0338

MRID 41394404Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

66 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 s tated

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, p iloerection, ataxia, body tremors, labored and shallow respiration, s light 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 anim als that survivedDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

67 the observation period exhibited no gross pathologic findings during necropsy.

CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid

REFERENCE

EPA

- HQ

- OPP

- 2006

- 0338

MRID 42296101Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

68 Study 4: Acute inhalation toxicity study of DDAC in ra ts

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: 8 70.1300

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/concen trations 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 administer ed 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.Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

69 CONCLUSIONS

None stated

STUDY RELIABILITY

[1] Valid

REFERENCE

EPA

- HQ

- OPP

- 2006

- 0338

MRID 00145074

TRID 455201010Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

70 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 complia nt?: 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 remark s: 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, prostrat ion, 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 andDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

71 enlarged kidneys. Gross lesions at necropsy of surviv ors 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 420538 01Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

72 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% purit y) 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.Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

73 RELIABILITY C ODE

[ 1 ]

- Valid

REFERENCE

EPA

- HQ

- OPP

- 2006

- 0338

MRID 42161601Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

74 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)

Remar ks: 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 r abbit 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 conjunctiva l 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 substa nce is corrosive to rabbit eyes. Toxicity Category I.

RELIABILITY CODE

[ 1 ]

- ValidDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

75 REFERENCE

EPA

- HQ

- OPP

- 2006

- 0338

MRID 42161602Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

76 B

- 4. SKIN SENSITIZATION

Study 1: Skin sensitization study in guinea pigs

Title: Mammalian Toxicity

TEST SUBSTANCE

Ide ntity: 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: G uinea 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

N ot a dermal sensitizer.

RELIABILITY CODE

[ 4 ]

– Not assignableDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

77 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 dat a

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

- 28

- 3

78 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 o r 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 an imals.

CONCLUSIONS

Not a dermal sensitizer.

RELIABILITY CODE

[ 1 ]

- ValidDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

79 REFERENCES

EPA

- HQ

- OPP

- 2006

- 0338

MRID 46367601Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

80 B

- 5 . REPEATED DOSE TOXICITY STUDY

Summary of endpoint: Adequate

Study 1: Repeated

- dose toxicity study of DDAC in rats

Tit le: 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 870.3 100

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 ma les; 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 st atedDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

81 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 observat ions

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 40966302Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

82 Study 2: Repeated

- dose toxicity study of DDAC in rats

Title: Mammalian Toxicity

The study is: Adequate Not Adequate

TEST SUBSTANCE

Ide ntity: Didecyldimethylammonium chloride (DDAC; CAS No. 7173

- 51

- 5)

Remarks: 80.8% pure

METHOD

Method/guideline followed: OPPTS 870.3 250

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/d ay)

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

w eeks.Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

83 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, acanth osis, 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

EP A

- HQ

- OPP

- 2006

- 0338

MRID 41305901Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

84 Study 3: Repeated

- dose toxicity study of DDAC in mice

Title: Mammalian Toxicity

The study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: Didecyldimethylammonium chloride (DDA C; 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 pp m (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) for 78 weeks.Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

85 RESULTS

NOAEL and LOAEL:

LOAEL = 155.5/193.1 mg/kg

- bw/day (males/females, based on decreased in mean body

weights and bo dy 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

histo pathological observations. Hematological values were comparable among all study groups.

CONCLUSIONS

None stated

RELIABILITY CODE

[1] Valid

REFERENCES

EPA

- HQ

- OPP

- 2006

- 0338

MRID 41802301Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

86 Study 4: Repeated

- dose toxicity study of DDAC in dogs

Title: Mammalian Toxicity

The study is: Adequate Not Adequate

This study i s not adequate for the repeated

- dose endpoint as dogs are not a preferred species for

testing.

TEST SUBSTANCE

Identity: Didecyldimethylammonium chlo ride (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.Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

87 RESULTS

NOAEL and LOAEL:

LOAEL = 50 mg/kg

- bw/day (based on decreased body weight gain, food consumption, an d

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 40262901Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

88 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 statedDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

89 Method remarks: Beagle dogs (4/sex/dose) were administe red 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/kg

bw/day.

RESULTS

NOAEL and LOAEL:

LOAE L = 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

- do se animals. Hematology or

urinalysis results were normal. Total cholesterol levels were significantly decreased in the high

dose 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 40 262901Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

90 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: Didecyldimethy lammonium chloride (DDAC; CAS No. 7173

- 51

- 5)

Remarks: 50% pure

METHOD

Method/guideline followed: 870.51 00

Test Type : Bacteria reverse mutation assay

Test system: Bacteria, in vitro

GLP (Y/N): Not stated

Year study performed: Not stated

Species/Str ain/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 a nd 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 activ ation.

Remarks: Not mutagenic. Positive control responded appropriately.Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

91 CONCLUSIONS

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

RELIABILITY CODE

[ 1 ]

– Valid

REFERENCE

EPA

- HQ

- OPP

- 2006

- 0338

MRID 40282201Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

92 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

MET HOD

Method/guideline followed: 870.53 00

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 hams ter ovary cells

Metabolic activation: With and without

Concentrations tested: 10 doses, ranging from 1.0 to 13.0 μg/mL without activation; doses

ranging from 1.0 to 4.0 μg/mL with activation.

Remarks: Vehicle control of deionized water

RESULTS

Overal l results: Negative

Cytotoxic concentration: None stated

Remarks: Acceptable response from positive and negative controls

CONCLUSIONS

Not genotoxic.Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

93 RELIABILITY CODE

[1]

- Valid

REFERENCE

EPA

- HQ

- OPP

- 2006

- 0338

MRID 93014008Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

94 B

- 7 . CHROMOSOMAL ABERR ATIONS 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: 870.537 5

Test Type: In v itro 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

Metaboli c 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 con centration: Not stated

Remarks: Positive and negative controls responded appropriatelyDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

95 CONCLUSIONS

Did not induce chromosomal aberrations

RELIABILITY CODE

[ 1 ]

- Valid

REFERENCE

EPA

- HQ

- OPP

- 2006

- 0338

MRID 41252601Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

96 Study 2: Unscheduled DNA synthesi s assay

Title: Genetic Toxicity

The study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: DDAC

Remarks: 80% purity

METHOD

Method/guideline followed: 870.5 5 50

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

Ove rall results: Negative

Cytotoxic concentration: Not stated

Remarks: The test material was lethal at concentrations exceeding

4.00 μ g/mL and excessively toxic at 4.00 μ g/mL.

Moderately high toxicity was observed at 2.00 μ g/mL

(74.6% survival), however n ormal cellular morphology

was observed and analysis could be performed.Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

97 CONCLUSIONS

Did not induce UDS

RELIABILITY CODE

[ 1 ]

- Valid

REFERENCE

EPA

- HQ

- OPP

- 2006

- 0338

MRID 93014007Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

98 B

- 7 . REPRODUCTIVE TOXICITY STUD Y

Summary of endpoint: Adequate

Stud y 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: D iet

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: D aily

Control group and treatment: 0 mg/kg/day

Post

- observation period: Not stated

Statistical methods: Not statedDraft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

99 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,

resp ectively).

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 repro ductive 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

red uced pup body weights.

CONCLUSIONS

None stated

RELIABILITY CODE

[ 1 ]

- Valid

REFERENCES

EPA

- HQ

- OPP

- 2006

- 0338

MRID 418045

- 01Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

100 B

- 8 . DEVELOPMENTAL TOXICITY STUDIES

Summary of endpoint: Adequate

Study 1: Developmental toxicity study of DDAC in rabbit s

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: 870.37 00

GLP: Not stated

Year study was performed: Not stated

Species/strain: New Zealand rabbits

Sex: Female ; 16/group

Route of administration: G avage

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

Exposure period: on gestation days 6 through 1 8

Frequency of treatme nt: 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.Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

101 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)

NOA EL (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: Materna l 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 ef fects

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

- 01Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

102 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/guideli ne 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 g avage

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

Exposure period: on gestat ion days 6 through 1 5

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 a dministered the test substance

(80.8% purity) via gavage at 0, 1, 10 and 20 mg/kg

- bw/day on days 6

– 15 of gestation.Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

103 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 mater nal 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 aft er 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 ossi fied parietal, and

poorly ossified sternebrae).

CONCLUSIONS

None stated

RELIABILITY CODE

[ 1 ]

- Valid

REFERENCES

EPA

- HQ

- OPP

- 2006

- 0338

MRID 41886701Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

104 B

- 9. CARCINOGENICITY STUDIES

Study 1: Carcinogenicity study of DDAC in rats

Title: Mammalian Toxici ty

The study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: DDAC

Remarks: 80.8 % purity

METHOD

Method/guideline followed: 870.43 00

GLP: Not stated

Year study was performed: Not stated

Test type: Carcinoge nicity

Species/strain: Sprague

- Dawley CD rats

Sex: 60/sex/dose

Route of administration: Di et

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 fema les)

Exposure period: 2 years

Frequency of treatment: D aily

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, 750Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

105 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

Re marks: 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 stud y 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 41965101Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

106 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: 870.43 00

GLP: Not stated

Year study was performed: Not stated

Test type: Carcinogenicity

Species/strain: CD

- 1 mice

Sex: 60/sex/dose

Route of administration: Di et

Doses: 0, 100, 500 or 1000 ppm (approx imately 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: D aily

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.Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

107 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 c linical 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

- 0338 MRID 41802301Draft HPV4 Chemical Data Adequacy Review CAS No. 68607

- 28

- 3

108 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