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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May-June 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Colour: colourless
- Odour: odourless
- CAS-Number: 89-32-7
- Molecular formula: C10 H2 O6
- Molecular weight: 218.12
Specific details on test material used for the study:
- Description: pale yellow crystalline solid
- Batch number: 7X18A
- Storage conditions: approximately 4 °C in the dark over silica gel

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 204-281 g
- Fasting period before study: overnight before dosing
- Housing: in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): certified Rat and Mouse Diet
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Air changes (per hr): 15 changes/hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: solubility & stability (test item is unstable in water)
Doses:
Using available information on the toxicity of the test material, 2000 mg/kg was chosen as the starting dose. One female was treated first. In the absence of toxicity at a dose level of 2000 mglkg, an additional group of 4 animals was treated with the same dose of 2000 mg/kg. A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study. All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
No. of animals per sex per dose:
5 animals at a dose of 2000 mg/kg
Control animals:
no
Details on study design:
- Frequency of weighing: Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14
- Frequency/duration of observation period following administration: Clinical observations were made 0.5, 1, 2, and 4 hours after dosing and subsequently once daily for fourteen days
- Necropsy: At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Statistics:
none

Results and discussion

Preliminary study:
Using available information on the toxicity of the test material, 2000 mg/kg was chosen as the starting dose. One female was treated first. In the absence of toxicity at a dose level of 2000 mglkg, an additional group of 4 animals was treated with the same dose of 2000 mg/kg
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deatha observed.
Clinical signs:
No signs of systemic toxicity were noted.
Body weight:
All animals showed expected gains in bodyweight over the observation period.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley rat was estimated to be greater than 2000 mg/kg bw.
Executive summary:

The study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley rat. The method was designed to meet the requirements of the OECD Guidelines for Testing of Chemicals No 420 "Acute Oral Toxicity - Fixed Dose Method" (adopted 17 December 2001) and Method Bl bis Acute Toxicity (Oral) of Commission Directive 2004/73/EC Method. Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test material, as a suspension in arachis oil, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths. There were no signs of systemic toxicity. All animals showed expected gains in bodyweight. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley rat was estimated to be greater than 2000 mg/kg bodyweight.