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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 11 May 2004 to 01 June 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD test guideline No. 423 and in compliance with GLP.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Remarks:
UK GLP Compliance Programme (Inspected on 2002-12-02)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): ST 30 C 03
- Substance type: pure active substance
- Physical state: colourless liquid
- Storage condition of test material: Approximately 4 °C under nitrogen in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Female Sprague-Dawley CD (Crl: CD® (SD) IGS BR) strain rats were supplied by Charles River (UK) Ltd, Margate, Kent, UK.
- Age at study initiation: eight to twelve weeks old
- Weight at study initiation: 184-204 g
- Fasting period before study: overnight fast immediately before dosing and for approximately three to four hours after dosing§
- Housing: The animals were housed in groups of three in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): ad libitum (Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C to 25 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 11 May 2004 To: 01 June 2004

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
In the absence of data suggesting the test material was toxic, 2000 mg/kg bw was chosen as the starting dose (limit test).
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 females (3+3)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: Signs of systemic toxicity noted during the study were hunched posture, lethargy, ataxia, diarrhoea, pilo-erection, increased activity, pallor of the extremities, decreased respiratory rate and laboured respiration. Animals appeared normal two or three days after dosing.
Statistics:
Not applicable (limit test)

Results and discussion

Preliminary study:
Not Applicable (In the absence of data suggesting the test material was toxic, 2000 mg/kg bw was chosen as the starting dose (limit test))
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death were recorded during the test
Clinical signs:
Signs of systemic toxicity noted during the study were hunched posture, lethargy, ataxia, diarrhoea, pilo-erection, increased activity, pallor of the extremities, decreased respiratory rate and laboured respiration. Animals appeared normal two or three days after dosing.
Body weight:
All animals showed expected gains in bodyweight over the study period
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (Female) > 2500 mg/kg bw (OECD 423 flowchart)
Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the following method: OECD Guidelines for the Testing of Chemicals No. 423 “Acute Oral Toxicity – Acute Toxic Class Method” (adopted 17 December 2001).

In the absence of data suggesting the test material was toxic, a limit test at one dose level of 2000 mg/kg bw was carried out. A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bw. This was followed by a further group of three fasted females at the same dose level. The test material was administered orally undiluted. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths. Signs of systemic toxicity noted during the study were hunched posture, lethargy, ataxia, diarrhoea, pilo-erection, and increased activity, pallor of the extremities, decreased respiratory rate and laboured respiration. Animals appeared normal two or three days after dosing. All animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy.

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated from the OECD Guideline 423 flow chart Test Procedure with a Starting Dose of 2000 mg/kg bw as being greater than 2500 mg/kg bw.

The test material does not meet the criteria for classification according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.

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