Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and appropriate guidelines
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
Principles of method if other than guideline:
not relevant
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Identity: PB-370
Reference No. E7061-46
Storage: room temperature
Physical description: off white powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Young adults Sprague-Dawley (Tac:N[SD]fBR) rats received from Taconic farms, Germantown, New -York.
Diet: Fresh tap water and Purina Laboratory Rodent Chow 5001 available ad libitum.
Room temperature: 66-70 deg F.
RH: 22-65%
12hr fluorescent light and 12 hour dark cycle.
Animal identification: ear tags and cage cards.
Body weights: 200-215 gr.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Animals were fasted overnight prior to dosing. Immediately prior to dosing, body weights ranged from 200 grams to 215 grams.
Test material was introduced directly into the stomach of each animal by means of a ball tipped intubation needle. animals were dosed (5000mg/kg) approx. 2.5 hr after initiation of the light cycle.
Doses:
5000mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
See attached file on methods
Statistics:
n/a

Results and discussion

Preliminary study:
n/a
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
The only clinical signs were chromorhinorrhea, diarrhea,
chromodacryorrhea and abdominogenital staining. These
clinical signs were noted only in the first 6 hours after
treatment.
Body weight:
All rats gained weight by day 14 of the study
Gross pathology:
Effects on organs:
No treatment-related organ effects.
Other findings:
n/a

Any other information on results incl. tables

see attached document on results

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Test material is classified as practically non-toxic (the oral LD50 of the test material is judged to be greater than 5000 mg/kg) to both male and female rats.
Executive summary:

Ten Sprague-dawly rats (5 males and 5 females) were orally dosed with PB-370 as 50% (w/v) mixture in corn oil at a dosage level of 5000 mg/kg. Observations for toxicity were conducted at 0.5, 1, 2, 3, 4 and 6 hours on the day of dosing and twice daily thereafter for 13 days. On day 14 they were conducted once. Body weights were recoeded on days 0, 7 and 14 of the study. A gross necropsy was performed on all animals.

There were no deaths. The only clinical signs noted were chromorhinorrhea, diarrhea, chromodacryorrhea and abdominogenital staining. These symptoms appeared during the first 3 -6 hours after dosing and vanished afterwards. All rats gained weight during the study. At necropsy, no gross internal lesions were noted in any animals.

Under the conditions of the study test material is classified as practically non-toxic (the oral LD50 of the test material is judged to be greater than 5000 mg/kg) to both male and female rats.