Registration Dossier

Administrative data

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

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Oxon, UK.
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 164 g. Body weight variation did not exceed +/- 20% of the body weight of the initially dosed animals.
- Fasting period before study: Overnight fast immediately before dosing and approximately three to four hours after dosing.
- Housing: suspended solid floor polypropylene cages furnished with wood chippings.
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 5 days

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Justification for choice of vehicle: Arachis oil was used because the test item did not dissolve/suspend in distilled water.

MAXIMUM DOSE VOLUME APPLIED:
2,000 mg/kg
Doses:
In the absence of data regarding the toxicity of the test item, 300 mg/kg was chosen as the starting dose.
In the absence of toxicity at the dose level of 300 mg/kg, an additional dose level of 2,000 mg/kg was included.
No. of animals per sex per dose:
300 mg/kg - 1 animal
2,000 mg/kg - 5 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 1/2, 1, 2 and 4 hours after dosing, and then daily for fourteen days. Individual body weights were recorded on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: external examination, opening abominal and thoracic cavities.

Results and discussion

Preliminary study:
There was no mortality; no signs of systemic toxicity were noted during the observation period.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
No signs of systemic toxicity were noted during the observation period.
Body weight:
All animals showed expected gains in body weight over the observation period.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test material in female Wistar strain rat was estimated to be greater than 2,000 mg/kg bodyweight.
Executive summary:

In an OECD 420 test guideline, conducted according to GLP conditions, the acute oral toxicity (LD50) of the test material to female Wistar rats is greater than 2,000 mg/kg bodyweight.