Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 15 April 2013 to 21 August 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
17-DEC-2001
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

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)
- Females nulliparous and non-pregnant: no data
- Age at study initiation: 8 weeks old
- Weight at study initiation: between 191 and 200 g
- Fasting period before study: no data
- Housing: by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid, with sawdust bedding which was changed at least 2 times a week.
- Historical data: no data
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25°C
- Humidity: 30-70%
- Air changes: 13 per hr
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 23 April 2013 To: 08 May 2013

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 g in 10 mL
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: no data

MAXIMUM DOSE VOLUME APPLIED: 10 mL


CLASS METHOD
- Rationale for the selection of the starting dose: no data
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily or on D0, 2, 7 and 14 for weighing
- Necropsy of survivors performed: yes
Statistics:
not applicable

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
no clinical signs
Body weight:
absence of body weight gain between day 2 and day 7 (compared to historical control), but normal therafter
Gross pathology:
no effect observed at necropsy

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
oral LD50 > 2000 mg/kg (rat, female, gavage in corn oil)
Executive summary:

In an acute oral toxicity study, groups of 8-week old Sprague-Dawley rats (6 females) were given a single oral dose of test substance in corn oil at dose 2000 mg/kg bw and observed for 14 days.


Oral LD50 Females > 2000 mg/kg bw