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

Endpoint summary

Description of key information

In skin and eye irritation studies in rabbits no indication of irritation was observed.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

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:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Principles of method if other than guideline:

Each of six adult (3 each M/F) New Zealand White rabbits were administered the test article and four skin sites – two abraded and two intact. Application sites were shaved. The skin was abraded using a 21-gauage burred needle; the abrasion penetrated the stratum corneum but not the dermis. Following the application of test material, one-inch square gauze patches were applied to each of the four sites. The animal’s trunk was then wrapped with a rubber dam and an Ace bandage to retard evaporation. The test substance was kept in contact with the skin site for 24 hrs. At the end of exposure, the wrappings were removed and the skin wiped to remove any remaining material. Animals were observed for signs of erythema and edema and scored according to the Draize scale at 24 and 72 hrs after the test article was applied.

GLP compliance:

yes

Specific details on test material used for the study:

Saytex 42-77, Lot BR-3

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Individually caged. Light cycle: 12 hrs light, 12 hrs dark. Room temperature was 20 +/- 3 degrees C. Humidity was 30-70%.Annual testing of drinking water by Pennsylvania Gas and Water Company. Rabbits were fed Wayn Rabbit Ration ad libitum.

Type of coverage:

occlusive

Preparation of test site:

other: clipped & one side abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

o.5 mL/site

Duration of treatment / exposure:

24 hr

Observation period:

24 and 72 hr post-treatment

Number of animals:

6

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: All

Score:

0.71

Max. score:

0

Reversibility:

other: not applicable

Rabbit Number	Sex	Weight (kg)		Observed Effects
				24 Hours				72 Hours
				Erythema		Edema		Erythema		Edema
		Initial	Final	Intact	Abraded	Intact	Abraded	Intact	Abraded	Intact	Abraded
2744 2745 2746 2747 2748 2749	M M M F F F	2.796 2.744 2.749 2.184 2.276 2.221	2.889 2.467 2.836 2.288 2.427 2.409	1-1 1-2 0-0 0-0 0-0 0-0	2-2 1-2 0-0 0-0 0-1 0-0	1-1 1-1 1-1 1-1 0-0 1-1	1-1 1-1 1-1 1-1 0-0 1-1	0-0 - 0-0 0-0 0-0 0-0	0-0 - 0-0 0-0 0-0 0-0	0-0 - 0-0 0-0 0-0 0-0	0-0 - 0-0 0-0 0-0 0-0
Totals				2-4	3-5	5-5	5-5	0-0	0-0	0-0	0-0
Mean Values Erythema/Edema				1.0	1.3	1.7	1.7	0.0	0.0	0.0	0.0
Total Erythema/Edema				2.3		3.4		0.0		0.0
Primary Irritation Index (Total/8)				0.71				0.0

One rabbit died on study (non-compound related).

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

EBTBP was mildly irritating to the skin of rabbits.

Executive summary:

EBTBP (500 mg) was applied to the clipped abraded and intact skin of 6 albino rabbits. The test site was wrapped with an impervious material. The wrapping was removed at 24 hr and the test site scored by the Draize method. The test site was also scored at 72 post-treatment. The test substance was considered to be a mild skin irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

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 1500.42 - Hazardous Substances and Articles, Administration and Enforcement Regulations, U.S. Federal Register, 38(187)P 27019, 27 Sept 1973

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Principles of method if other than guideline:

0.1 g instilled in one eye of each of 6 rabbits. test material not washed from eye. observed 1, 24, 48 & 72 h & 5 and 7 d post treatment.

GLP compliance:

not specified

Species:

rabbit

Strain:

other: albino rabbits

Vehicle:

unchanged (no vehicle)

Controls:

other: each animal served as own control

Amount / concentration applied:

0.1 gm in one eye of each rabbit

Duration of treatment / exposure:

test material not washed from eye

Observation period (in vivo):

observed 1, 24, 48 & 72 h & 5 and 7 d post treatment.

Number of animals or in vitro replicates:

6

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: all time points

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: all scores at all time points were 0

Eyes observed for corneal opacity, iris, conjunctival redness and chemosis, and discharge.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

EBTBP is not an eye irritatnt.

Executive summary:

EBTBP (100 mg) was instilled in the right eye of six albino rabbits. The treated eyes were observed at 1, 24, 48 and 72 hours and 5 and 7 days post treatment. No effects were observed at any time point in any animal with respect to the cornea, iris, or conjunctiva. The test article was not an eye irritant. 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The substance did not induce skin or eye irritation in standard studies in rabbits. It is unlikely from these results that the substance is an respiratory irritant. The acute inhalation study did not show any signs of irritation to the respiratory tract.

Justification for selection of skin irritation / corrosion endpoint:
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.

Justification for selection of eye irritation endpoint:
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.

Justification for classification or non-classification

Due to the absence of skin and eye irritation in standard studies in rabbits, the substance is not classified for these endpoints.