Registration Dossier

Administrative data

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:
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 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:
no abnoralities were observed
Body weight:
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:
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 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:
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.
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

Additional information

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.