Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 July 2013 - 13 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 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Identification: GL500
Batch: 20130510
Purity: 99.81%
Expiry date: 10 May 2018
Storage Conditions: room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan laboratories UK Ltd, Oxon, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks of age.
- Weight at study initiation:
- Fasting period before study: Overnight fast immediately before dosing.
- Housing: Suspended solid floor polypropylene cages furnished with wood flakes.
- Diet (e.g. ad libitum): 2014C Teklad Global Rodent Diet.
- Water (e.g. ad libitum):Free access to mains drinking water.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19° to 25°C
- Humidity (%): 30% to 70%
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours darkness.

IN-LIFE DATES: From: 18 July 2013 To:-13 August 2013

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
No analysis was cobducted to determine the homogeneity, concentration or stablity of the test item formulation. his is an exception with regard to GLP and has ben reflected in the GLP compliance statement.

MAXIMUM DOSE VOLUME APPLIED: 2000mg/Kg


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data regarding the toxicity of the test item, 300mg/kg was chosen as the starting dose.
Doses:
6 doses
No. of animals per sex per dose:
1 female at 300mg/kg
5 females at 2000mg/kg
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0.5, 1, 2 and 4 hours after dosing and then daily for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Individual body weights were recorded on Day 0 and Days 7 and 14.

Results and discussion

Preliminary study:
At dose level 300mg/kg no mortality was observed. Based on these results a dose level of 2000mg/kg was investigated.
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
No signes of systemic toxicity were noted during the observation period.
Body weight:
All animals showed expected gains in bodyweights over the observation period.
Gross pathology:
No abnormalites were noted during necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000mg/kg body weight (GHS-Unclassified).
Executive summary:

Introduction:

The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.

Methods:

Following a sighting test at dose levels of 300mg/kg and 2000mg/kg, a further group of four fasted females was given a single oral dose of test item at a dose level of 2000mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All anmals were subjected to gross necropsy.

Results:

There were no deaths. There were no signs of Systemic toxicity. All animals showed expected gains in bodyweights over the observation period. No abnormalites were noted during necropsy.

Conclusion:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000mg/kg body weight (GHS-Unclassified).