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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

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Additional Technical Point of Contact Information

Technical Point of Contact : 

Title : 

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Sponsor Information

Sponsor's Name : EPA

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Technical Point of Contact Information

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Title : 

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Fax Number : 

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 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.
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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
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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
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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:
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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:
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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
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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
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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:
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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:
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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
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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
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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
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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:
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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)