Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study:

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
none

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle, France)
- Age at study initiation: 8 weeks
- Weight at study initiation: 185 g - 200 g
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 19 °C and 24°C
- Humidity (%): between 41 % and 59 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: feed
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2000 mg/kg body weight of the test item diluted in olive oil

MAXIMUM DOSE VOLUME APPLIED: volume of 10 mL/kg body weight
Doses:
Group 2: 2000 mg/kg bw
Group 1: received, according to the same experimental conditions, the control item (distilled water) under a volume of 2 mL/kg body weight.
No. of animals per sex per dose:
Graup 1 (contro]): 6 female rats;
Group 2 (treated - 2000 mg/kg): 3 female rats, 3 female rats
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Day 1 - Day 14
- Frequency of weighing: D0, D2; D7;D14
- Necropsy of survivors performed: yes
Statistics:
n.a.

Results and discussion

Preliminary study:
n.a.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occnrred during the study.
Clinical signs:
No clinical signs related to the administration ofthe test item were observed.
Body weight:
The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related
changes.
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The test item was administered to a group of 6 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight. The experimental protoeol was established on the basis of the offieial method as defined in the O.E.C.D. guideline N° 423 dated December 17th, 2001 and the test method B.ltris ofthe Directive N° 2004/73/EC. No mortality oecurred during the study. No clinieal signs related to the administration of the test item were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopical examination of the animals at the end of the study did not reveal treatrnent-related ehanges. In eonclusion, the LD,o of the test item is higher than 2000 mg/kg body weight by oral route in the rat. According to the criteria for classification, paekaging and labelling of dangerous substanees and preparations in aceordance with the E.E.C. Directives 67/548, 2001159 and 99/45, the test item must not be classified. No symbol and risk phrase are required.