### High Production Volume Information System (HPVIS) | High Production Volume (HPV) Challenge | OPPT | US EPA

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# High Production Volume Information System (HPVIS)

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# Submission Report

Submission Information
Submission ID : 25349518 Submission Name : Phosphonic acid, dibutyl ester AR Number :


## Chemical Information
CAS Number : 1809-19-4 Ninth Collective Index Name : Phosphonic acid, dibutyl ester



## Submitter Information
Submitter's Name : EPA Address : City : Washington State : DC ZIP/Postal Code : Country : Type of Submitter : Company 

## Technical Point of Contact Information
Technical Point of Contact : Title : Phone Number : Fax Number : E-Mail Address : 

## Additional Technical Point of Contact Information
Technical Point of Contact : Title : Phone Number : Fax Number : E-Mail Address : 

## Sponsor Information Sponsor's Name : EPA Address : City : State : ZIP/Postal Code : Country : Phone Number : Fax Number : Share

### High Production Volume Information System (HPVIS) | High Production Volume (HPV) Challenge | OPPT | US EPA

http://iaspub.epa.gov/hpvis/ServSubmissionPrint [6/15/2011 11:25:36 AM] E-Mail Address : Type of Sponsor : Company 

## Technical Point of Contact Information
Technical Point of Contact : Title : Phone Number : Fax Number : E-Mail Address :



## Acute Toxicity

CAS Number : 1809-19-4

Sponsored Chemical Name : Phosphonic acid, dibutyl ester


### Test Substance - Acute Toxicity
Test Substance: (1809-19-4) Phosphonic acid, dibutyl ester

Test Substance Purity/Composition and Other Test Substance Comments: Clear colorless liquid; purity not reported

Sponsored Chemical Result Type: 

### Method - Acute Toxicity
Route of Administration: Oral
Type of Exposure: Gavage
Species: Rat

Mammalian Strain: Sprague-Dawley

Gender: Male

Number of Animals per Dose: 5

Dose: 1000, 2150, 4640 and 10,000 mg/kg-bw
Year Study Performed: 1974

Method/Guideline Followed: Other

GLP: No Data

Method/Guideline and Test Condition Remarks: This test procedure is in accordance with the Code of Federal Regulations (Part 191.1, Chap I, Title 21) for evaluating highly toxic substances.
The animals were observed for 14 days after treatment for mortalities and signs of toxicity.
Animal weight range was 170-225 grams

The 10,000 mg/kg dose level was assumed.

### High Production Volume Information System (HPVIS) | High Production Volume (HPV) Challenge | OPPT | US EPA

http://iaspub.epa.gov/hpvis/ServSubmissionPrint [6/15/2011 11:25:36 AM] Test Results - Acute Toxicity Concentration (LC/LD) : LC/LD % Value Description Value/Lower Concentration Upper Concentration Units

LD 50 % = 3690 mg/kgbw

Number of Deaths ( Male ): 9
Number of Deaths ( Female ): N/A
Number of Deaths ( Total ): 9

Results Remarks: Death occurred in 4/5 rats at 4640 mg/kg and 5/5 rats at 10,000 mg/kg. Slight to moderate depression was noted at all dose levels.
Conclusion: None stated


### Reliability/Data Quality - Acute Toxicity Reliability: 2 - Valid With Restrictions

Reliability Remarks: Missing study details including test substance purity and GLP compliance. Key Study Sponsor Indicator: 

### Reference - Acute Toxicity
Reference: Study information taken from a TSCATS submission OTS0538481 (TSCA 8(e) submission 8EHQ-92-8985; DCN No. 88920007348, pg. 6)



## Acute Toxicity

CAS Number : 1809-19-4

Sponsored Chemical Name : Phosphonic acid, dibutyl ester


### Test Substance - Acute Toxicity
Test Substance: (1809-19-4) Phosphonic acid, dibutyl ester

Test Substance Purity/Composition and Other Test Substance Comments: Clear colorless liquid; purity not reported

Sponsored Chemical Result Type: 

### Method - Acute Toxicity
Route of Administration: Dermal

### High Production Volume Information System (HPVIS) | High Production Volume (HPV) Challenge | OPPT | US EPA

http://iaspub.epa.gov/hpvis/ServSubmissionPrint [6/15/2011 11:25:36 AM] Type of Exposure: Occlusive

Species: Rabbit

Mammalian Strain: New Zealand White

Gender: Both M/F

Number of Animals per Dose: 4

Dose: 4640 mg/kg

Year Study Performed: 1974

Method/Guideline Followed: Other

GLP: No Data

Method/Guideline and Test Condition Remarks: The test procedure employed is in accordance with the procedure described in the Code of Federal Regulations (Part 191.1, Chap I, Title 21) for evaluating highly toxic substances.
New Zealand White albino rabbits, in the 1.8 - 2.3 weight range were used in this study. Two male and two female rabbits had the test material applied to the closely clipped, intact abdominal skin beneath a protective binder. After a 24-hour period, the binder material was removed, the abdominal skin was inspected for irritation, and the test site was washed with soap and water and rewrapped in a gauze binder. The test animals were observed for a 14-day period following the initial treatment.



### Test Results - Acute Toxicity Concentration (LC/LD) : LC/LD % Value Description Value/Lower Concentration Upper Concentration Units

LD 50 % > 4640 mg/kg

Number of Deaths ( Male ): 0
Number of Deaths ( Female ): 0
Number of Deaths ( Total ): 0

Results Remarks: No mortalities or signs of toxicity were observed. Local effects included severe necrosis, edema and subdermal hemorrhaging.

Conclusion: None stated

### High Production Volume Information System (HPVIS) | High Production Volume (HPV) Challenge | OPPT | US EPA

http://iaspub.epa.gov/hpvis/ServSubmissionPrint [6/15/2011 11:25:36 AM] Reliability/Data Quality - Acute Toxicity Reliability: 3 - Not Valid

Reliability Remarks: Missing study details including test substance purity and GLP compliance. Key Study Sponsor Indicator: 

### Reference - Acute Toxicity
Reference: Study information taken from a TSCATS submission OTS0538481 (TSCA 8(e) submission 8EHQ-92-8985; DCN No. 88920007348, pg. 9)



## Repeated-Dose Toxicity

CAS Number : 1809-19-4

Sponsored Chemical Name : Phosphonic acid, dibutyl ester


### Test Substance - Repeated-Dose Toxicity
Test Substance: (1809-19-4) Phosphonic acid, dibutyl ester

Test Substance Purity/Composition and Other Test Substance Comments: Sponsored Chemical Result Type: 

### Method - Repeated-Dose Toxicity
Route of Administration: Type of Exposure:

Species:

Mammalian Strain:

Gender:

Number of Animals per Dose:
Dose:

Year Study Performed:

Method/Guideline Followed:
GLP:

Exposure Period:

Frequency of Treatment:

### High Production Volume Information System (HPVIS) | High Production Volume (HPV) Challenge | OPPT | US EPA

http://iaspub.epa.gov/hpvis/ServSubmissionPrint [6/15/2011 11:25:36 AM] Post-Exposure Period:

Method/Guideline and Test Condition Remarks: 

### Test Results - Repeated-Dose Toxicity Concentration (LOAEL/ LOAEC/ NOAEL/ NOAEC) : LOAEL/ LOAEC/ NOAEL/ NOAEC Population Value Description Value/Lower Concentration Upper Concentration Units

Results Remarks:

Conclusion:


### Reliability/Data Quality - Repeated-Dose Toxicity Reliability:

Reliability Remarks: As of February 2010, no data were available for this endpoint.

Key Study Sponsor Indicator: 

### Reference - Repeated-Dose Toxicity
Reference:



## Genetic Toxicity in vivo

CAS Number : 1809-19-4

Sponsored Chemical Name : Phosphonic acid, dibutyl ester


### Test Substance - Genetic Toxicity in vivo
Test Substance: (1809-19-4) Phosphonic acid, dibutyl ester

Test Substance Purity/Composition and Other Test Substance Comments: Sponsored Chemical Result Type: 

### Method - Genetic Toxicity in vivo Type of Study:

Type of Test:

### High Production Volume Information System (HPVIS) | High Production Volume (HPV) Challenge | OPPT | US EPA

http://iaspub.epa.gov/hpvis/ServSubmissionPrint [6/15/2011 11:25:36 AM] Route of Administration:

Type of Exposure:

Species:

Strain:

Gender:

Dose:

Year Study Performed:

Method/Guideline Followed:
GLP:

Duration of Treatment/ Exposure Period and Units: Frequency of Treatment:

Positive, Negative, and Solvent Control Substance(s): Number of Animals per Sex and Dose Group:
Method/Guideline and Test Condition Remarks: 

### Test Results - Genetic Toxicity in vivo Systemic Toxicity:

Genotoxic Effect:

Results Remarks:

Conclusion:


### Reliability/Data Quality - Genetic Toxicity in vivo Reliability:

Reliability Remarks: As of February 2010, no data were available for this endpoint. Key Study Sponsor Indicator: 

### Reference - Genetic Toxicity in vivo
Reference:



## Genetic Toxicity in vitro

CAS Number : 1809-19-4

### High Production Volume Information System (HPVIS) | High Production Volume (HPV) Challenge | OPPT | US EPA

http://iaspub.epa.gov/hpvis/ServSubmissionPrint [6/15/2011 11:25:36 AM] Sponsored Chemical Name : Phosphonic acid, dibutyl ester


### Test Substance - Genetic Toxicity in vitro
Test Substance: (1809-19-4) Phosphonic acid, dibutyl ester

Test Substance Purity/Composition and Other Test Substance Comments: Sponsored Chemical Result Type: 

### Method - Genetic Toxicity in vitro Type of Study:

Concentrations:

Year Study Performed:

Method/Guideline Followed:
GLP:

Postive, Negative, and Solvent Control Substance(s):
Method/Guideline and Test Condition Remarks: 

### Test Results - Genetic Toxicity in vitro Details on Cytogenetic Assay:
Statistics:

Effect : Species Other Species Strain Other Strain Metabolic Activation Genotoxic Effect Conclusion

Results Remarks:

Conclusion:


### Reliability/Data Quality - Genetic Toxicity in vitro Reliability:

Reliability Remarks: As of February 2010, no data were available for this endpoint. Key Study Sponsor

### High Production Volume Information System (HPVIS) | High Production Volume (HPV) Challenge | OPPT | US EPA

http://iaspub.epa.gov/hpvis/ServSubmissionPrint [6/15/2011 11:25:36 AM] Indicator: 

### Reference - Genetic Toxicity in vitro
Reference:



## Reproductive Toxicity

CAS Number : 1809-19-4

Sponsored Chemical Name : Phosphonic acid, dibutyl ester


### Test Substance - Reproductive Toxicity
Test Substance: (1809-19-4) Phosphonic acid, dibutyl ester

Test Substance Purity/Composition and Other Test Substance Comments: Sponsored Chemical Result Type: 

### Method - Reproductive Toxicity
Route of Administration: Type of Exposure:

Species:

Mammalian Strain:

Gender:

Number of Animals per Dose:
Dose:

Year Study Performed:

Method/Guideline Followed:
GLP:

Exposure Period:

Frequency of Treatment: Post-Exposure Period:

Method/Guideline and Test Condition Remarks: Pre-Mating Exposure / Males: Pre-Mating Exposure / Females:

### High Production Volume Information System (HPVIS) | High Production Volume (HPV) Challenge | OPPT | US EPA

http://iaspub.epa.gov/hpvis/ServSubmissionPrint [6/15/2011 11:25:36 AM] Test Results - Reproductive Toxicity Concentration (LOAEL/ LOAEC/ NOAEL/ NOAEC) : LOAEL/ LOAEC/ NOAEL/ NOAEC Population Value Description Value/Lower Concentration Upper Concentration Units

Results:

Results Remarks:

Conclusion:


### Reliability/Data Quality - Reproductive Toxicity Reliability:

Reliability Remarks: As of February 2010, no data were available for this endpoint.

Key Study Sponsor Indicator: 

### Reference - Reproductive Toxicity
Reference:



## Developmental Toxicity/Teratogenicity

CAS Number : 1809-19-4

Sponsored Chemical Name : Phosphonic acid, dibutyl ester


### Test Substance - Developmental Toxicity/Teratogenicity
Test Substance: (1809-19-4) Phosphonic acid, dibutyl ester

Test Substance Purity/Composition and Other Test Substance Comments: Sponsored Chemical Result Type: 

### Method - Developmental Toxicity/Teratogenicity
Route of Administration: Type of Exposure:

Species:

### High Production Volume Information System (HPVIS) | High Production Volume (HPV) Challenge | OPPT | US EPA

http://iaspub.epa.gov/hpvis/ServSubmissionPrint [6/15/2011 11:25:36 AM] Mammalian Strain:

Gender:

Number of Animals per Dose:
Dose:

Year Study Performed:

Method/Guideline Followed:
GLP:

Exposure Period:

Frequency of Treatment: Post-Exposure Period:

Method/Guideline and Test Condition Remarks: 

### Test Results - Developmental Toxicity/Teratogenicity Concentration (LOAEL/ LOAEC/ NOAEL/ NOAEC) : LOAEL/ LOAEC/ NOAEL/ NOAEC Population Value Description Value/Lower Concentration Upper Concentration Units

Results Remarks:

Conclusion:


### Reliability/Data Quality - Developmental Toxicity/Teratogenicity Reliability:

Reliability Remarks: As of February 2010, no data were available for this endpoint.

Key Study Sponsor Indicator: 

### Reference - Developmental Toxicity/Teratogenicity
Reference:



## Skin Irritation

### High Production Volume Information System (HPVIS) | High Production Volume (HPV) Challenge | OPPT | US EPA

http://iaspub.epa.gov/hpvis/ServSubmissionPrint [6/15/2011 11:25:36 AM] CAS Number : 1809-19-4

Sponsored Chemical Name : Phosphonic acid, dibutyl ester



### Test Substance - Skin Irritation
Test Substance: (1809-19-4) Phosphonic acid, dibutyl ester

Test Substance Purity/Composition and Other Test Substance Comments: Clear, colorless liquid; purity not reported

Sponsored Chemical Result Type: 

### Method - Skin Irritation Species: Rabbit

Mammalian Strain: No Data
Type of Coverage: Open
Preparation of Test Site: No Data

Gender: No Data
Number of Animals per Dose: 6

Amount/Concentration Applied: Year Study Performed: 1974

Method/Guideline Followed: Other

GLP: No Data
Exposure Period: 4 Hours
Total Volume applied and Units: No Data
Control Group Type: No Data

Vehicle Used: No Data

Vehicle Name:

Vehicle Amount and Units:

Post-Exposure Period: 48 Hours
Grading Scale:

Method/Guideline and Test Condition Remarks: Primary skin irritation was determined according to the proposed FDA revision of the test for primary skin irritants published in the Code of Federal Regulations (Part 191, Chapter 1, Title 21) for evaluating hazardous substances.

Substance was administered to intact skin of 6 rabbits (2

### High Production Volume Information System (HPVIS) | High Production Volume (HPV) Challenge | OPPT | US EPA

http://iaspub.epa.gov/hpvis/ServSubmissionPrint [6/15/2011 11:25:36 AM]sites per rabbit) for 4 hours and observed for erythemaeschar and edema for 48 hours.
The proposed test differs from the procedure described in the Hazardous Substance Labeling Act, in that irritation is determined after a 4-hour exposure period. In the proposed test, readings are made 4-, 24- and 48- hours after treatment. Animals are retained for observation for 96 hours after initial application. Any delayed necrosis is reported, but the data will not be used in determination of irritation indices. A corrosive substance is defined as a material that causes tissue destruction within 48 hours after application on any of the twelve intact sites.



### Test Results - Skin Irritation
Grade:

Primary Irritation Index: 5.8

Lesions:

Erythema:

Edema:

Results Remarks: Two rabbits developed subdermal hemorrhage. All animals except one showed eschar formation. Scores among the six rabbits ranged from 2.0 to 7.3. Interpretation of Results: Corrosive

Conclusion: The test substance is classified as corrosive.


### Reliability/Data Quality - Skin Irritation Reliability: 2 - Valid With Restrictions

Reliability Remarks: Non-recommended exposure period (4 hours) and missing study details including test substance purity, GLP compliance, animal sex and strain and preparation of test site. Key Study Sponsor Indicator: 

### Reference - Skin Irritation
Reference: The study summary is taken from a TSCATS submission OTS0538481 (TSCA 8(e) submission 8EHQ-92-8985; DCN No. 88920007348, pg. 7, 10)



## Eye Irritation

CAS Number : 1809-19-4

Sponsored Chemical Name : Phosphonic acid, dibutyl ester


### Test Substance - Eye Irritation
Test Substance: (1809-19-4) Phosphonic acid, dibutyl ester

Test Substance Purity/Composition and Other Test Substance Clear, colorless liquid; purity not reported

### High Production Volume Information System (HPVIS) | High Production Volume (HPV) Challenge | OPPT | US EPA

http://iaspub.epa.gov/hpvis/ServSubmissionPrint [6/15/2011 11:25:36 AM] Comments: Sponsored Chemical Result Type: 

### Method - Eye Irritation Species: Rabbit

Mammalian Strain: New Zealand White

Gender: No Data
Number of Animals per Dose: 6

Amount/Concentration Applied: Year Study Performed: 1974

Method/Guideline Followed: Other

GLP: No Data
Exposure Period:

Total Volume applied and Units: 0.1 ml
Control Group Type: Negative

Vehicle Used: No

Vehicle Name:

Vehicle Amount and Units:

Post-Exposure Period: 14 Days
Grading Scale:

Tool: No Data

Method/Guideline and Test Condition Remarks: Procedure is in accordance with the test for eye irritants outlined in the code of Federal Regulations (Part 191.12, Chap. 1, Title 21) for evaluating hazardous substances.
Six New Zealand White rabbits in the 1.6 - 2.1 kg weight range were used as the test animals. The test material was placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test material is dropped. The lids were gently held together for three seconds and the animal released. The other eye, remaining untreated, served as the control. The eyes were observed at 24-, 48-, and 72-hours following treatment and scored for irritation properties



### Test Results - Eye Irritation Overall Grading Score:

Overall Irritation Score:

### High Production Volume Information System (HPVIS) | High Production Volume (HPV) Challenge | OPPT | US EPA

http://iaspub.epa.gov/hpvis/ServSubmissionPrint [6/15/2011 11:25:36 AM] EPA Home Privacy and Security Notice Contact Us http://iaspub.epa.gov/hpvis/ServSubmissionPrint Print As-Is Last updated on Wednesday, June 15, 2011 Primary Irritation Index:

Lesions:

Cornea:

Iris:
Conjunctivae (Chemosis):
Conjunctivae (Redness):

Results Remarks: Corneal damage: Mild to moderate ocular opacity occurred at every test site.

Iritis: Some mild inflammation was noted at two test sites.
Conjunctivae: a) erythema - little or no erythema was noted b) chemosis - little or no edema was noted c) discharge - little or not discharge was noted
Signs of remission: Five animals showed complete remission of all symptoms within 14 days, however, one animal showed only partial remission of the corneal opacity and complete remission of the other symptoms Interpretation of Results: Other

Conclusion: The test substance is classified as a severe irritant.


### Reliability/Data Quality - Eye Irritation Reliability: 2 - Valid With Restrictions

Reliability Remarks: Missing study details including test substance purity, GLP compliance and animal sex Key Study Sponsor Indicator: 

### Reference - Eye Irritation
Reference: The study summary is taken from a TSCATS submission OTS0538481 (TSCA 8(e) submission 8EHQ-92-8985; DCN No. 88920007348, pg. 8)