N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)

Endpoint summary

Description of key information

EBTBP was administered as a single dose of 2,000 mg/kg to the clipped skin of 6 albino rabbits. The skin of three of the animals was abraded prior to treatment. The test site was wrapped with an impervious material. The wrapping was removed at 24 hr, any excess test article removed, and the animals observed for 14 days. No animals died during the test. The dermal LD50 was > 2,000 mg/

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines. The study was performed prior to established guidelines and GLPs.

Qualifier:

according to guideline

Guideline:

other: Section 1500.41 - Hazardous Substances and Articles, Administration and Envforcement Regulations, U.S. Federal Register, 38(187), p 27019, 27 Sept 1973.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Principles of method if other than guideline:

5 male and 5 female rats administered a single oral dose by gavage in corn oil of 7.5 g/kg, and observed for 14 d.

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

Single oral dose of 7.5 g/kg bw

No. of animals per sex per dose:

5 males and 5 female

Control animals:

no

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 7.5 other: gm/kg bw

Based on:

test mat.

Remarks on result:

other: no rats died on test

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

EBTBP was not acutely toxic to rats by the oral route.

Executive summary:

One group of 5 male and 5 female Sherman-Wistar rats was administered a single dose of EBTBP by gavage in corn oil at 7,500 mg/kg. The animals were observed for 14 days. No animals died on test. The oral LD50 was > 7,500 mg/kg. 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

7 500 mg/kg bw

Quality of whole database:

No lethality or adverse effects were observed after acute oral, dermal and inhalation exposure of the substance at or above the limit doses.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines.

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

aerodynamic dyameter of particle size = 6.0 microns +- 2.22.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetric

Duration of exposure:

1 h

Concentrations:

203 mg/L

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Sex:

male/female

Dose descriptor:

LC0

Effect level:

203 mg/L air

Based on:

test mat.

Exp. duration:

1 h

No rats died on the study.

Dyspnea was observed during the exposure and continued post-exposure (up to 5 days) in a few animals. Mean body weight gain was normal 14 days after exposure. At necropsy, red foci in the lungs of a few rats were observed.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The 1 hr LC50 was > 203 mg/L.

Executive summary:

One group of 5 male and 5 female albino rats was exposed to EBTBP at a concentration of 203 mg/L for 1 hour. Dyspnea and nasal discharge were the principal signs observed during the exposure. No deaths occurred during treatment or the during the 14 day observation period. The inhalation LC50 was > 203 mg/L for 1 hour. This study was performed according to Good Laboratory Practices.  

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

203 000 mg/m³ air

Quality of whole database:

One group of 5 male and 5 female albino rats was exposed to EBTBP at a concentration of 203 mg/L for 1 hour. Dyspnea and nasal discharge were the principal signs observed during the exposure. No deaths occurred during treatment or the during the 14 day observation period. The inhalation LC50 was > 203 mg/L for 1 hour. This study was performed according to Good Laboratory Practices.  

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines. The study was performed prior to established guidelines and GLPs.

Qualifier:

according to guideline

Guideline:

other: Section 1500.41 - Hazardous Substances and Articles, Administration and Envforcement Regulations, U.S. Federal Register, 38(187), p 27019, 27 Sept 1973.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)

Principles of method if other than guideline:

Test material applied to clipped back of rabbits, covered in place for 24 hr and observed for toxicity and mortality for 14 d.

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Species:

rabbit

Strain:

other: albino rabbits

Sex:

not specified

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hr

Doses:

single dose of 2.0 gm/kg bw

No. of animals per sex per dose:

6 rabbits total

Control animals:

no

Sex:

not specified

Dose descriptor:

LD0

Effect level:

> 2 other: gm/kg

Based on:

test mat.

Mortality:

no rabbits died on test

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

EBTBP was not acutely toxic when administered dermally to rabbits.

Executive summary:

EBTBP was administered as a single dose of 2,000 mg/kg to the clipped skin of 6 albino rabbits. The skin of three of the animals was abraded prior to treatment. The test site was wrapped with an impervious material. The wrapping was removed at 24 hr, any excess test article removed, and the animals observed for 14 days. No animals died during the test. The dermal LD50 was > 2,000 mg/

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines. The study was performed prior to established guidelines and GLPs.

Additional information

The substance did not produce any lethality or toxic effects after acute administraion via the oral, dermal or inhalation route at dose levels up to or above the limit dose.

Justification for selection of acute toxicity – oral endpoint
A valid oral toxicity study in rats is available.

Justification for selection of acute toxicity – inhalation endpoint
A valid acute inhalation study in rats is available.

Justification for selection of acute toxicity – dermal endpoint
A valid dermal toxiicty study in rabbits is available

Justification for classification or non-classification

The substance was not acutely toxic following oral, dermal or inhalation exposure. Therefore a classificaiton for acute toxicity is not warranted.