Registration Dossier

Administrative data

Description of key information

The acute lethal oral dose to rats was found to be: greater than 5.0 g / kg bodyweight
The acute lethal dermal dose to rats was found to be: greater than 2.0 g / kg bodyweight
The acute inhalation study is waived because of low vapour pressure and low exposure.

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

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).

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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
exposure considerations
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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:
10 September to 16 October 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study in accordance with internationally recognised guideline
Qualifier:
according to
Guideline:
other: Directive 84/449/CEE - B3
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
other: Rat Wistar
Strain:
other: HanIbm: WIST (SPF)
Sex:
male/female
Type of coverage:
occlusive
Vehicle:
other: Polyéthylène-glycol
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not required
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
Aucun signe de toxicité n'a été observé pendant l'essai.
Gross pathology:
Effects on organs:
Aucune anomalie n'a été observée à l'examen macroscopique
post mortem à la fin de l'étude.
Other findings:
Signs of toxicity (local):
On a noté aucune irritation de la peau pendant l'essai.

No mortality occurred during 15 days of observation.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Toxicity was estimated to be greater than 2000 mg/kg
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Justification for selection of acute toxicity – oral endpoint
Key study

Justification for selection of acute toxicity – inhalation endpoint
Key study

Justification for selection of acute toxicity – dermal endpoint
Key study

Justification for classification or non-classification

The oral and dermal studies return LD50's of 5.0 and 2.0 g / kg bw and the inhalation study is waived on grounds of low vapour pressure and low exposure. Therefore, the substance is not classified for acute toxicity.