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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 March to 9 August 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study in accordance with internationally recognised guideline

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: The study was designed to evaluate the acute toxicity of PEP-36 following a single oral dose to rats according to Environmental Protection Agency, Toxic Substances Control Act Test Guidelines, 40 CFR Part 798, Subpart B, 1985.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Rat Crl : SD
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Huile de maïs
Doses:
Range finding: 50, 100, 1000, 2500,and 5000 mg/kg of body weight,
Main study: 5000 mg/kg of body weight
No. of animals per sex per dose:
Range finding study: 1
Main study: 5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
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:
Des fécés molles (2/10) sans valeur toxicologique et
coloration de l'urine de 3/10 réversible au jour 2.

Aucun autre signe lié au traitement n'a été remarqué.
Gross pathology:
Effects on organs:
On a observé une décoloration du foie (3/10) et des reins
(2/10) et des contenus anormaux dans les intestins dans 2
femelles et 4 mâles.


Intestins contenant un liquide jaune (3/10) ou rouge( 2/10)
ou pâteux (1/10)

Any other information on results incl. tables

In the Single Dose Study (5000 mg/kg of body weight), clinical observations consisted of urine stains and soft faeces. No observable gross pathology findings were noted in two males and one female; while, observable gross pathology findings in the remaining animals involved the liver and kidneys (discolored) and intestines (abnormal contents).

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the results of the study, the acute oral LD50 was estimated to be greater than 5000 mg/kg of body weight in male and female and combined male and female rats.