1,1'-isopropylidenebis[4-(allyloxy)-3,5-dibromobenzene]

Endpoint summary

Description of key information

The test substance was evalueted for its acute oral toxicity potential in rats. The study was performed according to GLP following oral administration of a single dose to the rats.

No mortality occurred during the study and no abnormalities were observed.

There was no effect on body weight gain.

The gross necropsy conducted at termination of the study revealed no observable abnormalities.

The acute oral LD50 was determined to be greater than 5000 mg/kg bw.

The test substance was evalueted for its acute dermal toxicity potential in rabbits. The study was performed according to GLP following dermal administration of a single dose to the rabbits.

No mortality occurred during the study and there was no effect on body weight gain.

Moderate to slight erythema and edema decreasing in severity and area with time.

Five/ten animals appeared normal by day 2.

Ten/ten animals appeared normal by day 7.

The gross necropsy conducted at termination of the study revealed no observable abnormalities.

The acute dermal LD50 was determined to be greater than 2000 mg/kg bw.

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:

November 1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The rats were quarantined and acclimated to laboratry conditions for 14 days prior the initiation of the study. Animals were observed twice daily during the quarantine period. In the last day of the quarantine period, one group consisting of ten rats (5 males and 5 females) were selected and used for the study.
The animals were randomly placed in numbered cages. Each rat was sexed, weighted and ear punched. Body weights ranged from 212 to 268g. The rats were individually housed in wire-bottomed cages suspended above the droppings.

Route of administration:

oral: feed

Vehicle:

corn oil

Details on oral exposure:

One solution of test material and vehicle was made using corn oil (33.3% w/v). The amount of test material vehicle solution was measured in a plastic disposable syringe and administered directly in the rat's stomach as a single dose using a rubber catheter and tubing adapter.
Individual dose amounts were calculated using fasted body weights, taken prior to dosing.

Doses:

5 g/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

Water and food were offered ad libitum, except during the 4 hours period immediately prior to oral intubation, when food was withheld.
Approximately one hour after dosing, food was offered.
All animals selected for the study were weighted on days -1, 0, 6 and 13.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths occurred

Clinical signs:

other: no abnoralities were observed

Gross pathology:

no abnoralities were observed

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 5000 mg/kg bw

Executive summary:

The test substance was evalueted for its acute oral toxicity potential in rats. The study was performed according to GLP following oral administration of a single dose to the rat.

No mortality occurred during the study and no abnormalities were observed.

There was no effect on body weight gain.

The gross necropsy conducted at termination of the study revealed no observable abnormalities.

The acute oral LD50 was determined to be greater than 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

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:

1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

The rabbits were quarantined and acclimated to laboratory conditions for 6 days prior to initiation of the study.
Animals were observed twice deny during the quarantine period. On the last day of the quaerentine period (i.e. the day prior to initiation of exposure to the test material) ten rabbits (5 males and 5 fernals) were selected from the animal shipment used for the study.
Each rabbit was sexed, weighted and ear tagged with a unique animal number and each cage bore that number.
Body weights were measured and they ranged from 2.05 to 2.45 kilograms. The rabbits were individually housed in steel wire-bottomed cages suspended above the droppings.

Type of coverage:

occlusive

Vehicle:

physiological saline

Details on dermal exposure:

Individual dose amounts were calculated using day 0 body weights. The test materiel was slightly moistened with physiological saline and applied to the test site on each rabbit from a plastic disposable weigh boat. A glass stirring rod was used to distribute the test material evenly over the exposure site (approximately 240 cm2). Just prior to the application of the test material, the skin test site on all of the animals was abraded by making a series of parallel, epidermal abrasions, every 2 or 3 centimeters longitudinally with a 25-gauge hypodermic needle. These abrasions were made sufficiently deep to penetrate the stratum corneum but not to disturb the derma or to produce bleeding.
Each test site was immediately occluded with a layer of 4-ply gauze, two single layers thick. The trunk of the rabbit was wrapped with rubber latex dental dam and the dental dam taped at the edges with 1 inch Micropore tape to form an airtight occlusive wrap. To prevent oral ingestion of the test material, each rabbit was maintained in a Newmann harness for the twenty-four hours exposure period.

Duration of exposure:

The test material remained in contact with the skin for twenty-four hours.

Doses:

2 g/kg

No. of animals per sex per dose:

5 male and 5 femals

Control animals:

no

Details on study design:

All animals selected for the study were weighed at -1, 0, and 13 days.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths occurred

Clinical signs:

other: no abnoralities were observed

Gross pathology:

no abnoralities were observed

Other findings:

Moderate to slight erythema and edema decreasing in severity and area with time.
Five/ten animals appeared normal by day 2.
Ten/ten animals appeared normal by day 7.

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 2000 mg/kg

Executive summary:

When BE-51 was administered dermally at a single dose of 2 g/kg to ten albino rabbits (5 males and 5 females) no signs of systemic toxicity or mortality were noted. Evaluation of local skin reactions revealed moderate to slight erythema and edema decreasing in severity and area with time. (Five/ten animals appearing normal by day 2 and the others appearing normal by day 7.) No significant gross pathologic findings were observed.

From the data presented. The LD50 of BE-51 is greater than 2000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Justification for classification or non-classification

The acute oral LD50 was determined to be greater than 5000 mg/kg bw and the acute dermal LD50 was determined to be grater than 2000 mg/kg bw, therefore the substance is not classified according to CLP regulation.