Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18/06/2015 - 07/07/2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: E15-01025
- Expiration date of the lot/batch: not supplied
- Purity test date: 100%
- Physical state/appearance: balck powder
- 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
- Females (if applicable) nulliparous and non-pregnant: [yes/no]yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: +/- 20% of the mean body weight
- Fasting period before study: 1 overnight fast immediately before dosing and for approx 3-4 hours after dosing
- Housing: housed in groups of 4 in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): free access to food (2014C Teklad Global Rodent diet, Harlan laboratories)
- Water (e.g. ad libitum):free access to mains drinking water
- Acclimation period: at least 5 days
- On receipt randomly allocated to cages

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70%
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12h light (6-18h) and 12h dark
IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Remarks:
arachis oil is used because the test item does not dissolve/suspend in distilled water
Details on oral exposure:
VEHICLE
- Formulation within 2 hours of being applied to the test system

Doses:
- single dose
- 2000 mg/kg bw
- concentration 200 mg/ml
- dose volume: 10 mL/kg
No. of animals per sex per dose:
5
Details on study design:
- volume administered to each animal was calculated according to the fasted body weight at the time of dosing.
- treatment of animals was sequential
- sufficient time was allowed between each dose group to confirm the survival of the previously dosed animals.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
no signs of systemic toxicity
clinical observations were made 30 min, 1, 2 and 4 hours after dosing and then daily for 14 days. Morbidity and mortality checks were made twice daily.
Body weight:
expected gains
individuel body weight were recorded day 0 (day of dosing), day 7 and day 14
Other findings:
no abnormalities were noted at 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 2000 mg/kg body weight. The test item does not meet the criteria for classification according to EC 1272/2008.
Executive summary:

Introduction

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

Methods

Following a sighting test at a dose level of 2000mg/kg, an additional four fasted female animals were given a single oral doseoftest item,as a suspension in arachis oil BP, at a dose level of 2000mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

Results

Mortality.

There were no deaths.
Clinical Observations.

There were no signs of systemic toxicity.

Body Weight.

All animals showed expected gains in body weight.

Necropsy.

No abnormalities were noted at necropsy.

Conclusion

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

The test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and PackagingofSubstances and Mixtures