Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
2018

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1'-isopropylidenebis[4-(allyloxy)-3,5-dibromobenzene]
EC Number:
246-850-8
EC Name:
1,1'-isopropylidenebis[4-(allyloxy)-3,5-dibromobenzene]
Cas Number:
25327-89-3
Molecular formula:
C21H20Br4O2
IUPAC Name:
1,3-dibromo-5-{2-[3,5-dibromo-4-(prop-2-en-1-yloxy)phenyl]propan-2-yl}-2-(prop-2-en-1-yloxy)benzene
Test material form:
solid: particulate/powder

Test animals

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.

Administration / exposure

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.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths occurred
Clinical signs:
no abnoralities were observed
Body weight:
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.

Applicant's summary and conclusion

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.