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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11th April 2007 to 1st May 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of inspection: 30th August 2005 Date of signature: 21st November 2005
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsor's identification: C-C1
Description : dark blue powder
Batch number : MB-1
Date received : 05 March 2007
Storage conditions: room temperature in the dark over silica gel

Test animals

Species:
other: Rat (Sprague-Dawley)
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: eight to twelve weeks of age
- Weight at study initiation: 206 - 229 g
- Fasting period before study: overnight fast immediately before dosing and for approximately three to four hours after dosing
- Housing: housed in groups of up to four in suspended solid floor polypropylene cages furnished with woodflakes
- Diet: ad libitum access to Certified Rat and Mouse Diet
- Water: ad libitum access to mains drinking water
- Acclimation period: acclimatisation period of at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

IN-LIFE DATES: From: Day 0 To: Day 14 (End of observation period)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Distilled water
Details on oral exposure:
VEHICLE
-not applicable.
For the purpose of the study the test material was freshly prepared, as required, as a solution suspension in distilled water.

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

DOSAGE PREPARATION (if unusual): not unusual

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data suggesting the test material was toxic, 2000 mg/kg was chosen as the starting dose.
Doses:
Dose level of 2000 mg/kg bodyweight
No. of animals per sex per dose:
Preliminary sighting study: 1 (female)
Main study: 4 (female)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Clinical observations were made ½, 1, 2, and 4 hours after dosing and subsequently once daily for fourteen days. Morbidity and mortality checks were made twice daily.

Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14

- Necropsy of survivors performed: yes

Statistics:
not applicable

Results and discussion

Preliminary study:
There was no mortality.
No signs of systemic toxicity.
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:
Clinical observations:
There were no signs of systemic toxicity.
Blue-coloured staining of the faeces and urine was noted in four animals during the observation period.
Body weight:
All animals showed expected gains in bodyweight over the observation period.
Gross pathology:
Effects on organs:
Abnormalities noted at necropsy of all animals were dark liver and blue stained kidneys.
Other findings:
Bodyweight

All animals showed expected gains in bodyweight during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the female Sprague Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight (CLP Reguation (EC) No. 1272/2008).
Executive summary:

Introduction. The study was performed to assess the acute oral toxicity of the test material in the Sprague‑Dawley CD strain rat. The method was designed to meet the requirements of the following:

§        OECD Guidelines for Testing of Chemicals No 420 “Acute Oral Toxicity - Fixed Dose Method” (adopted)

§        Method B1bis Acute Toxicity (Oral) of Commission Directive 2004/73/EC

Method. Following a sighting test in which there was no mortality 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 solution in distilled water, 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.

Mortality. There were no deaths.

Clinical Observations. There were no signs of systemic toxicity.

Blue-coloured staining of the faeces and urine was noted in four animals during the observation period. 

Bodyweight. All animals showed expected gains in bodyweight.

Necropsy. Abnormalities noted at necropsy of all animals were dark liver and blue stained kidneys.

Conclusion. The acute oral median lethal dose (LD50) of the test material in the female Sprague‑Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System-Unclassified).