SRC TR-09-224

HPV4 CHEMICAL DATA ADEQUACY REVIEW AND ROBUST SUMMARY ADEQUACY 

REQUIREMENTS 

2H-3,1-BENZOXAZINE-2,4(1H)-DIONE

Prepared by:

Christopher Janson and Joan D. Garey

Environmental Science Center

Syracuse Research Corporation

7502 Round Pond Road

North Syracuse, NY 13212

Contract No. EP-W-04-019

Task FA411.4.409.009

Submitted to:

OPPT/RAD/HPVCB (7403M)

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue

Washington, D.C. 20460

Kathleen C. Kennedy, Project Officer

David Brooks, Work Assignment Manager

July 17, 2009
TOXICITY TO AQUATIC VERTEBRATES

Summary of endpoint: Iadequate

Title: Acute/Prolonged Toxicity to Fish

The study is: Adequate Not Adequate

This study is not adequate due to a lack of study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: Bestimmung der Wirkung von Wasserinhaltsstoffen suf Fische, DIN 38412, 

Teil 15 

GLP: No

Year study performed: 1982

Test type: Static

Species/strain/supplier: Leuciscus idus

Analytical monitoring: Yes

Exposure period: 96 hours

Number of animals/sex/dose: Not stated 

Statistical methods used: Not stated

Method remarks: Not stated

RESULTS

Nominal concentrations: Not stated

Measured concentrations: Not stated

Element value: LC50 = 46 – 100 mg/L; NOEC = 22 mg/L

Remarks: None
CONCLUSIONS 

None

RELIABILITY CODE

3 

REFERENCES

IUCLID DATASET for chemical
TOXICITY TO AQUATIC INVERTEBRATES

Summary of endpoint: Adequate

Title: Acute Toxicity to Aquatic Invertebrates

The study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: Directive 84/449/EEC, C.2 “Acute Toxicity for Daphnia”

GLP: No

Year study performed: 1988

Test type: Not stated

Species/strain/supplier: Water flea (Daphnia magna)

Analytical monitoring: No

Exposure period: 24 hours

Number of animals/sex/dose: Not stated

Statistical methods used: Not stated

Method remarks: Directive 84/449/EEC, C.2 “Acute Toxicity for Daphnia”

RESULTS

Nominal concentrations: Not stated

Measured concentrations: Not stated

Element value: EC50 = 110 mg/L; EC0 = 62.5 mg/L; EC100 = 250 mg/L

Remarks: None 
CONCLUSIONS 

None

RELIABILITY CODE

2 

REFERENCES

IUCLID Dataset for the chemical
Title: Acute Toxicity to Aquatic Invertebrates

The study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: Directive 84/449/EEC, C.2 “Acute Toxicity for Daphnia”

GLP: No

Year study performed: 1988

Test type: Not stated

Species/strain/supplier: Water flea (Daphnia magna)

Analytical monitoring: No

Exposure period: 48 hours

Number of animals/sex/dose: Not stated

Statistical methods used: Not stated

Method remarks: Directive 84/449/EEC, C.2 “Acute Toxicity for Daphnia”

RESULTS

Nominal concentrations: Not stated

Measured concentrations: Not stated

Element value: EC50 = 86 mg/L; EC0 = 62.5 mg/L; EC100 = 125 mg/L

Remarks: None 

CONCLUSIONS 

None
RELIABILITY CODE

2

REFERENCES

IUCLID Dataset for the chemical
TOXICITY TO AQUATIC PLANTS

Summary of endpoint: Inadequate

Title: Toxicity to Aquatic Plants e.g. Algae

The study is: Adequate Not Adequate

This study is not adequate due to a lack of study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks:

METHOD

Method/guideline followed: Scenedesmus-Zellvermehrungs-Hemmtest, DIN 38412 Teil 9, Bestimmung 

der Hemmwirkung von Wasserinhaltsstoffen auf Gruenalgen

Test type: Not stated

GLP: No

Year: 1988

Species/strain/supplier: Scenedesmus subspicatus (Algae)

Element Basis: Not stated

Exposure Period: 72 hours

Analytical Monitoring: No

Statistical Methods: Not stated

Method remarks: Not stated

RESULTS

Nominal concentrations: Not stated

Measured concentrations: Not stated

Element value: EC50 = 14.5 mg/L; EC10 = 5; EC90 = 34.9 mg/L

Remarks: None
CONCLUSIONS

None

RELIABILITY CODE

3

REFERENCE

IUCLID Dataset for the chemical
Title: Toxicity to Aquatic Plants e.g. Algae

The study is: Adequate Not Adequate

This study is not adequate due to a lack of study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks:

METHOD

Method/guideline followed: Scenedesmus-Zellvermehrungs-Hemmtest, DIN 38412 Teil 9, Bestimmung 

der Hemmwirkung von Wasserinhaltsstoffen auf Gruenalgen

Test type: Not stated

GLP: No

Year: 1988

Species/strain/supplier: Scenedesmus subspicatus (Algae)

Element Basis: Not stated

Exposure Period: 96 hours

Analytical Monitoring: No

Statistical Methods: Not stated

Method remarks: Not stated

RESULTS

Nominal concentrations: Not stated

Measured concentrations: Not stated

Element value: EC50 = 16 mg/L; EC10 = 4.5; EC90 = 36.9 mg/L

Remarks: None

CONCLUSIONS

None
RELIABILITY CODE

3

REFERENCE

IUCLID Dataset for the chemical
ACUTE TOXICITY STUDIES

Summary of endpoint: Adequate based on weight of evidence

Title: Acute Oral Toxicity

The study is: Adequate Not Adequate

This study is not adequate for the acute toxicity endpoint as it lacks many study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: Not stated

Type: Acute oral LD50

GLP: Not stated

Year: Not stated

Species/Strain: Rat

Sex: Not stated

No. of animals per sex per dose: Not stated

Vehicle: Not stated

Route of administration: Oral

Method remarks: None

RESULTS

LD50 value: 

> 5000 mg/kg-bw

Number of deaths at each dose level: Not stated

Remarks: Not stated

CONCLUSIONS

None
RELIABILITY CODE

3

REFERENCES 

IUCLID Dataset for chemical
Title: Acute Oral Toxicity

The study is: Adequate Not Adequate

This study is not adequate for the acute toxicity endpoint as it lacks many study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: BASF-TEST

Type: Acute oral LD50

GLP: No

Year: Not stated

Species/Strain: Rat

Sex: Not stated

No. of animals per sex per dose: Not stated

Vehicle: Not stated

Route of administration: Oral

Method remarks: Remarks are in German.

RESULTS

LD50 value: 

> 6400 mg/kg-bw

Number of deaths at each dose level: Not stated

Remarks: Not stated

CONCLUSIONS

None

RELIABILITY CODE

3
REFERENCES 

IUCLID Dataset for chemical
Title: Acute Oral Toxicity

The study is: Adequate Not Adequate

This study is not adequate for the acute toxicity endpoint as it lacks many study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: Not stated

Type: Acute oral LD50

GLP: No

Year: Not stated

Species/Strain: Rat

Sex: Not stated

No. of animals per sex per dose: Not stated

Vehicle: Not stated

Route of administration: Oral

Method remarks: Remarks are in German

RESULTS

LD50 value: 

> 2500 mg/kg-bw

Number of deaths at each dose level: Not stated

Remarks: Not stated

CONCLUSIONS

None

RELIABILITY CODE

3
REFERENCES 

IUCLID Dataset for chemical
Title: Acute Oral Toxicity

The study is: Adequate Not Adequate

This study is not adequate for the acute toxicity endpoint as it lacks many study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: Not stated

Type: Acute oral LD50

GLP: No

Year: Not stated

Species/Strain: Mouse

Sex: Not stated

No. of animals per sex per dose: Not stated

Vehicle: Not stated

Route of administration: Oral

Method remarks: Remarks are in German

RESULTS

LD50 value: 

> 1000 mg/kg-bw

Number of deaths at each dose level: Not stated

Remarks: Not stated

CONCLUSIONS

None

RELIABILITY CODE

3
REFERENCES 

IUCLID Dataset for chemical
Title: Acute Oral Toxicity

The study is: Adequate Not Adequate

This study is not adequate for the acute toxicity endpoint as it lacks many study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: Not stated

Type: Acute oral LD50

GLP: No

Year: Not stated

Species/Strain: Mouse

Sex: Not stated

No. of animals per sex per dose: Not stated

Vehicle: Not stated

Route of administration: Oral

Method remarks: None

RESULTS

LD50 value: 

= 250 mg/kg-bw

Number of deaths at each dose level: Not stated

Remarks: Not stated

CONCLUSIONS

None

RELIABILITY CODE

3
REFERENCES 

IUCLID Dataset for chemical
Title: Acute Oral Toxicity

The study is: Adequate Not Adequate

This study is not adequate for the acute toxicity endpoint as it lacks many study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: Not stated

Type: Acute oral LD50

GLP: No

Year: Not stated

Species/Strain: Cat

Sex: Not stated

No. of animals per sex per dose: Not stated

Vehicle: Not stated

Route of administration: Oral

Method remarks: Remarks are in German.

RESULTS

LD50 value: 

> 500 mg/kg-bw

Number of deaths at each dose level: Not stated

Remarks: Not stated

CONCLUSIONS

None

RELIABILITY CODE

3
REFERENCES 

IUCLID Dataset for chemical
Title: Acute Oral Toxicity

The study is: Adequate Not Adequate

This study is not adequate for the acute toxicity endpoint as it lacks many study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: Not stated

Type: Acute oral LD50

GLP: No

Year: Not stated

Species/Strain: Guinea pig

Sex: Not stated

No. of animals per sex per dose: Not stated

Vehicle: Not stated

Route of administration: Oral

Method remarks: Remarks are in German.

RESULTS

LD50 value: 

ca. 500 mg/kg-bw

Number of deaths at each dose level: Not stated

Remarks: Not stated

CONCLUSIONS

None

RELIABILITY CODE

3
REFERENCES 

IUCLID Dataset for chemical
Title: Acute Oral Toxicity

The study is: Adequate Not Adequate

This study is not adequate for the acute toxicity endpoint as it lacks many study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: Not stated

Type: Acute oral LD50

GLP: No

Year: Not stated

Species/Strain: Hen

Sex: Not stated

No. of animals per sex per dose: Not stated

Vehicle: Not stated

Route of administration: Oral

Method remarks: Remarks are in German.

RESULTS

LD50 value: 

> 2500 mg/kg-bw

Number of deaths at each dose level: Not stated

Remarks: Not stated

CONCLUSIONS

None

RELIABILITY CODE

3
REFERENCES 

IUCLID Dataset for chemical
Title: Acute Inhalation Toxicity

The study is: Adequate Not Adequate

This study is not adequate for the acute toxicity endpoint as it lacks many study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: Not stated

Type: Acute Inhalation LC50

GLP: Not stated

Year: Not stated

Species/Strain: Rat

Sex: Not stated

No. of animals per sex per dose: Not stated

Vehicle: Not stated

Route of administration: Inhalation

Exposure duration: 1 hour

Method remarks: None

RESULTS

LD50 value: 

= 192 mg/L

Number of deaths at each dose level: Not stated

Remarks: Not stated

CONCLUSIONS

None

RELIABILITY CODE
3

REFERENCES 

IUCLID Dataset for chemical
Title: Acute Inhalation Toxicity

The study is: Adequate Not Adequate

This study is not adequate for the acute toxicity endpoint as it lacks many study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: OECD Guide-line 403 “Acute Inhalation Toxicity”

Type: Acute Inhalation LC50

GLP: No

Year: 1981

Species/Strain: Rat

Sex: Not stated

No. of animals per sex per dose: Not stated

Vehicle: Not stated

Route of administration: Inhalation

Exposure duration: 4 hours

Method remarks: Remarks are in German.

RESULTS

LD50 value: 

> 5.3 mg/L

Number of deaths at each dose level: Not stated

Remarks: Not stated

CONCLUSIONS

None

RELIABILITY CODE
3

REFERENCES 

IUCLID Dataset for chemical
Title: Acute Inhalation Toxicity

The study is: Adequate Not Adequate

This study is not adequate for the acute toxicity endpoint as it lacks many study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: dynamische Inhalation nach Niessen et al.: Arch. Toxicol. 20, 44

Type: Acute Inhalation LC50

GLP: Not stated

Year: 1963

Species/Strain: Rat

Sex: Not stated

No. of animals per sex per dose: Not stated

Vehicle: Not stated

Route of administration: Inhalation via aerosol

Exposure duration: 4 hours

Method remarks: Remarks are in German.

RESULTS

LD50 value: 

> .348 mg/L

Number of deaths at each dose level: Not stated

Remarks: Not stated

CONCLUSIONS

None

RELIABILITY CODE
3

REFERENCES 

IUCLID Dataset for chemical
Title: Acute Inhalation Toxicity

The study is: Adequate Not Adequate

This study is not adequate for the acute toxicity endpoint as it lacks many study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: dynamische Inhalation nach Niessen et al.: Arch. Toxikol. 20, 44

Type: Acute Inhalation LC50

GLP: Not stated

Year: 1963

Species/Strain: Rat

Sex: Not stated

No. of animals per sex per dose: Not stated

Vehicle: Not stated

Route of administration: Inhalation via aerosol

Exposure duration: 4 hours

Method remarks: Remarks are in German

RESULTS

LD50 value: 

> .255 mg/L

Number of deaths at each dose level: Not stated

Remarks: Not stated

CONCLUSIONS

None

RELIABILITY CODE
3

REFERENCES 

IUCLID Dataset for chemical
Title: Acute Inhalation Toxicity

The study is: Adequate Not Adequate

This study is not adequate for the acute toxicity endpoint as it lacks many study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: BASF-Test

Type: Acute Inhalation IRT

GLP: No

Year: Not stated

Species/Strain: Rat

Sex: Not stated

No. of animals per sex per dose: Not stated

Vehicle: Not stated

Route of administration: Inhalation

Exposure duration: 8 hours

Method remarks: Remarks are in German.

RESULTS

LD50 value: 

Not stated

Number of deaths at each dose level: Not stated

Remarks: Not stated

CONCLUSIONS

None

RELIABILITY CODE
3

REFERENCES 

IUCLID Dataset for chemical
Title: Acute Inhalation Toxicity

The study is: Adequate Not Adequate

This study is not adequate for the acute toxicity endpoint as it lacks many study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: dynamische Inhalation nach Niessen et al.: Arch. Toxicol. 20, 44

Type: Acute Inhalation LC50

GLP: No

Year: 1963

Species/Strain: Mouse

Sex: Not stated

No. of animals per sex per dose: Not stated

Vehicle: Not stated

Route of administration: Inhalation via aerosol

Exposure duration: 4 hours

Method remarks: Remarks are in German.

RESULTS

LD50 value: 

> .378 mg/L

Number of deaths at each dose level: Not stated

Remarks: Not stated

CONCLUSIONS

None

RELIABILITY CODE
3

REFERENCES 

IUCLID Dataset for chemical
Title: Acute Inhalation Toxicity

The study is: Adequate Not Adequate

This study is not adequate for the acute toxicity endpoint as it lacks many study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: Not stated

Type: Other

GLP: No

Year: Not stated

Species/Strain: Mammal (not specified)

Sex: Not stated

No. of animals per sex per dose: Not stated

Vehicle: Not stated

Route of administration: Inhalation. Aerosol was utilized.

Exposure duration: 4 hours

Method remarks: Remarks are in German.

RESULTS

LD50 value: 

Not stated

Number of deaths at each dose level: Not stated

Remarks: Not stated

CONCLUSIONS

None

RELIABILITY CODE
3

REFERENCES 

IUCLID Dataset for chemical
Title: Acute Dermal Toxicity

The study is: Adequate Not Adequate

This study is not adequate for the acute toxicity endpoint as it lacks many study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: offene Applikation, intakte Haut, 7 Tauge

Type: Acute Dermal LD50

GLP: No

Year: Not stated

Species/Strain: Rat

Sex: Not stated

No. of animals per sex per dose: Not stated

Vehicle: Not stated

Route of administration: Dermal

Method remarks: Remarks are in German.

RESULTS

LD50 value: 

> 500 mg/kg-bw

Number of deaths at each dose level: Not stated

Remarks: Not stated

CONCLUSIONS

None

RELIABILITY CODE

3
REFERENCES 

IUCLID Dataset for chemical
Title: Acute Dermal Toxicity

The study is: Adequate Not Adequate

This study is not adequate for the acute toxicity endpoint as it lacks many study details.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: Not stated

Type: Acute Dermal LD50

GLP: Not stated

Year: Not stated

Species/Strain: Rabbit

Sex: Not stated

No. of animals per sex per dose: Not stated

Vehicle: Not stated

Route of administration: Dermal

Method remarks: Not stated

RESULTS

LD50 value: 

> 2000 mg/kg-bw

Number of deaths at each dose level: Not stated

Remarks: Not stated

CONCLUSIONS

None

RELIABILITY CODE

3
REFERENCES 

IUCLID Dataset for chemical
SKIN IRRITATION STUDIES

Title: Skin Irritation

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks:

METHOD

Method/guideline followed: BASF-Test

GLP (Y/N): No

Species/strain: Rabbit

Sex (males/females/both): Not stated

Number of animals/sex/dose: Not stated

Volume administered: Not stated

Test condition: Remarks are in German.

RESULTS

Not irritating

CONCLUSIONS

Not Irritating

RELIABILITY CODE

3

REFERENCES

IUCLID Dataset for chemical
Title: Skin Irritation

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks:

METHOD

Method/guideline followed: 24 Std. semiokklusiv, Applikation am Ohr

GLP (Y/N): No

Species/strain: Rabbit

Sex (males/females/both): Not stated

Number of animals/sex/dose: Not stated

Volume administered: Not stated

Test condition: Semi-occlusive exposure. 

RESULTS

Not irritating

CONCLUSIONS

Not Irritating

RELIABILITY CODE

3

REFERENCES

IUCLID Dataset for chemical
Title: Skin Irritation

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks:

METHOD

Method/guideline followed: 24 Std. semiokklusiv, Applikation am Unterarm

GLP (Y/N): No

Species/strain: Human

Sex (males/females/both): Not stated

Number of animals/sex/dose: Not stated

Volume administered: Not stated

Test condition: Semi-occlusive exposure. 

RESULTS

Not irritating

CONCLUSIONS

Not Irritating

RELIABILITY CODE

3

REFERENCES

IUCLID Dataset for chemical
EYE IRRITATION STUDIES

Title: Eye Irritation

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks:

METHOD

Method/guideline followed: Not stated

GLP (Y/N): Not stated

Species/strain: Rabbit

Sex (males/females/both): Not stated

Number of animals/sex/dose: Not stated

Volume administered: Not stated

Test condition: Not stated

RESULTS

Not irritating

CONCLUSIONS

Not Irritating

RELIABILITY CODE

3

REFERENCES

IUCLID Dataset for chemical
Title: Eye Irritation

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks:

METHOD

Method/guideline followed: BASF-Test

GLP (Y/N): No

Species/strain: Rabbit

Sex (males/females/both): Not stated

Number of animals/sex/dose: Not stated

Volume administered: Not stated

Test condition: Not stated

RESULTS

Irritating

CONCLUSIONS

Irritating

RELIABILITY CODE

3

REFERENCES

IUCLID Dataset for chemical
Title: Eye Irritation

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks:

METHOD

Method/guideline followed: Other

GLP (Y/N): No

Species/strain: Rabbit

Sex (males/females/both): Not stated

Number of animals/sex/dose: Not stated

Volume administered: Not stated

Test condition: Not stated

RESULTS

Not irritating

CONCLUSIONS

Not Irritating

RELIABILITY CODE

3

REFERENCES

IUCLID Dataset for chemical
SKIN SENSITIZATION STUDY

Title: Skin Sensitization Study

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: in Anlehnung an Part B: Methods for the Determination of Toxicity, EEC 

Directive 79/831/ Annex V; B. 6, Skin sensitization, June 1989

GLP (Y/N): Yes

Year: 1989

Species/strain: Guinea pigs

Sex (male/female/both): Not stated

Number of animals/sex/dose: Not stated

Dose/concentration: Not stated

Test condition: Not stated

RESULTS

Sensitizing

CONCLUSIONS

Sensitizing

RELIABILITY CODE

3

REFERENCES

IUCLID Dataset for chemical.
REPEATED-DOSE TOXICITY STUDY

Summary of endpoint: Inadequate

Title: Repeated-dose Toxicity

The study is: Adequate Not Adequate

This study cannot be properly evaluated for adequacy due to its being in German.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: dynamische Inhalation nach Niessen et al.: Arch. Toxicol. 20, 44

GLP: No

Year study was performed: 1963

Test type: Repeated-dose toxicity

Species/strain: Rat / Wistar

Sex: Both

Route of administration: Inhalation via aerosol

Doses: 0.0116; 0.071 mg/L (DMSO and Lutol 1:1)

Exposure period: 28 days

Frequency of treatment: 4 hours a day, 5 days a week over 28 days

Control group and treatment: Yes, concurrent vehicle

Post-observation period: None

Statistical methods: Cannot ascertain – study is in German.

Method remarks: Remarks are in German.

RESULTS

NOAEL and LOAEL: 
NOAEL = 0.0116 mg/L

Actual dose received by dose level by sex: Not stated

Remarks: Remarks are in German.

CONCLUSIONS

None stated.

RELIABILITY CODE

3 – Study details are in German.

REFERENCES

IUCLID Dataset for Chemical
Title: Repeated-dose Toxicity

The study is: Adequate Not Adequate

This study cannot be properly evaluated for adequacy due to its being in German.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: dynamische Inhalation nach Niessen et al.: Arch. Toxicol. 20, 44

GLP: No

Year study was performed: 1963

Test type: Repeated-dose toxicity

Species/strain: Rat / Wistar

Sex: Both

Route of administration: Inhalation via aerosol

Doses: 0.197 mg/L

Exposure period: 5 days

Frequency of treatment: 4 hours a day

Control group and treatment: Yes, concurrent vehicle

Post-observation period: 2 weeks

Statistical methods: Cannot ascertain – study is in German.

Method remarks: Remarks are in German.

RESULTS

NOAEL and LOAEL: 

LC50 > 0.197 mg/L

Actual dose received by dose level by sex: Not stated

Remarks: Remarks are in German.
CONCLUSIONS

None stated.

RELIABILITY CODE

3 – Study details are in German.

REFERENCES

IUCLID Dataset for Chemical
Title: Repeated-dose Toxicity

The study is: Adequate Not Adequate

This study cannot be properly evaluated for adequacy due to its being in German.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: in Anlehnung an Lim et al.: Arch. Int. Pharmacol. 130, 336

GLP: No

Year study was performed: 1961

Test type: Repeated-dose toxicity

Species/strain: Rat / Wistar

Sex: Male

Route of administration: Oral unspecified

Doses: max dose of 1000 mg/kg

Exposure period: 5 days

Frequency of treatment: daily

Control group and treatment: Not specified.

Post-observation period: 6-13 days

Statistical methods: Cannot ascertain – study is in German.

Method remarks: Remarks are in German.

RESULTS

NOAEL and LOAEL: 

Not stated

Actual dose received by dose level by sex: Not stated

Remarks: Remarks are in German.
CONCLUSIONS

None stated.

RELIABILITY CODE

3 – Study details are in German.

REFERENCES

IUCLID Dataset for Chemical
GENETIC TOXICITY STUDY

Summary of endpoint: Inadequate

Title: Genetic Toxicity ‘in Vitro’

The study is: Adequate Not Adequate

This study is not adequate due to no mention of control use and response.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: in Anlehnung an: Ames B.N. et al.: Proc. Natl. Acad. Sci. USA 70, 2281-

2285, (1973) und Ames, B.N. et al.: Mut. Res. 31, 347-364, (1975)

Test Type: HGPRT Assay in CHO cells for forward mutation

Test system: Bacterial cell, in vitro

GLP (Y/N): No

Year study performed: 1975

Species/Strain/cell-type/cell line: Salmonella typhimurium TA1535, TA100, TA1537, TA98

Metabolic activation: With and without

Concentrations tested: 20 μg – 5000 μg/plate

Remarks: Standard test plate.

RESULTS

Overall results: Negative

Cytotoxic concentration: Not stated

Remarks: None

CONCLUSIONS

Negative for genetic toxicity
RELIABILITY CODE

3

REFERENCE

IUCLID Dataset for chemical
CHROMOSOMAL ABERRATIONS STUDY

Summary of endpoint: Inadequate

Title: Genetic Toxicity ‘In Vivo’

The study is: Adequate Not Adequate

This study’s adequacy cannot be properly determined as the study result is given in German.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: OECD Guide-line 474 “Genetic Toxicology: Micronucleus Test”

Test Type: Micronucleus assay

Test system: In vivo

GLP (Y/N): Yes

Year study performed: 1983

Species/Strain/cell-type/cell line: NMRI mouse (males and females)

Metabolic activation: Not stated

Concentrations tested: Test substance was administered at 200, 670, 2000 mg/kg (24 h preparation 

interval), 2000 mg/kg (48 hour preparation interval)

Remarks: Administered via gavage.

RESULTS

Overall results: Not stated

Cytotoxic concentration: Not stated

Remarks: Remarks are in German.

CONCLUSIONS

Cannot be ascertained as it is in German.
RELIABILITY CODE

3

REFERENCE

IUCLID Dataset for the chemical
REPRODUCTIVE TOXICITY STUDIES

Summary of endpoint: Inadequate

Title: Toxicity to Reproduction 

The study is: Adequate Not Adequate

This study’s adequacy cannot be properly evaluated as the study details are in German; no NOAEL or 

LOAEL clearly provided.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: Other

GLP: No

Year study was performed: Not stated

Species/strain: Swiss mice

Sex: Both

Route of administration: Oral feed

Doses: 1% and 2% in food (ca. 2000 and 4000 mg/kg/day)

Exposure period: 21 days; pre-mating exposure was none for males and 7 days for females

Frequency of treatment: Daily

Control group and treatment: Yes (no additional information)

Post-observation period: Not stated

Statistical methods: Not stated

Method remarks: Remarks are in German.

RESULTS

NOAEL and LOAEL: 
Not stated

Remarks: Remarks are in German.

CONCLUSIONS

Remarks are in German.

RELIABILITY CODE

3

REFERENCES

IUCLID Dataset for chemical
Title: Toxicity to Reproduction 

The study is: Adequate Not Adequate

This study’s adequacy cannot be properly evaluated as the study details are in German; no NOAEL or 

LOAEL clearly provided.

TEST SUBSTANCE

Identity: 4H-3, 1-benzoxazine-2,4 (1H)-dione; CAS No. 118-48-9

Remarks: 

METHOD

Method/guideline followed: Other

GLP: No

Year study was performed: Not stated

Species/strain: Swiss mice

Sex: Female

Route of administration: Subcutaneous

Doses: 4 mg, 8 mg

Exposure period: 5 days; pre-mating exposure was 1.5 days for females.

Frequency of treatment: Cannot ascertain – in German.

Control group and treatment: Yes (treatment not specified)

Post-observation period: Not stated

Statistical methods: Not stated

Method remarks: Remarks are in German.

RESULTS

NOAEL and LOAEL: 

Not stated

Remarks: Remarks are in German.
CONCLUSIONS

Remarks are in German.

RELIABILITY CODE

3

REFERENCES

IUCLID Dataset for chemical
Summary of Endpoints

Endpoint Study Information 

Provided

Acceptable Data Gap

Aquatic Effects

Acute Toxicity to Fish Yes No Yes

Acute Toxicity to Daphnia Yes Yes No

Toxicity to Aquatic Plants Yes No Yes

Health Effects

Acute Toxicity Yes Yes No

Repeated-Dose Toxicity Yes No Yes

Genetic Mutation Yes No Yes

Chromosomal Aberrations Yes No Yes

Toxicity to Reproduction Yes No Yes

Developmental Toxicity No No Yes