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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:
Study test phase 2013-04-09 to 2013-05-07. Report complete 2013-06-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997).

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
lithium 3-((3,4-dicyanophenyl)thio)propane-1-sulfonate
EC Number:
700-787-7
Cas Number:
769953-18-6
Molecular formula:
C11H9N2O3S2Li
IUPAC Name:
lithium 3-((3,4-dicyanophenyl)thio)propane-1-sulfonate
Test material form:
solid: particulate/powder

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: 8-12 weeks
- Fasting period before study: Overnight fast immediately before dosing
- Housing: In groups of 3 in suspended solid floor polypropylene cages furnished with wooden flakes
- Diet (e.g. ad libitum): Free access to food except for fasting period overnight before dosing and for 3-4 hours after dosing.
- Water (e.g. ad libitum):Free access to water except for fasting period overnight before dosing and for 3-4 hours after dosing.
- Acclimation period: At least 5 days

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 300 mg/kg initially and then 2000 mg/kg
CLASS METHOD
- In the absence of data regarding the toxicity of the test item 300 mg/kg was chosen as the starting dose.
Doses:
300 mg/kg and 2000mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and susequently once daily for 14 days. Individual body weights were recorded prior to dosing and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical observations for signs of systemic toxicity, body weight, mortality

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths during the study
Clinical signs:
No signs of systemic toxicity were noted
Body weight:
All animals showed expected gains in body weight
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 acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be >2500 mg/kg body weight (Globally Harmonized Classification Sysytem - Unclassified).

The test material does not meet the criteria for classification according to EU labelling regulations Commission Directive 2001/59/EC for Classification and Labelling of Dangerous Sbstances or Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
Executive summary:

Introduction

The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat. The study was designed to be compatible with the following guidelines:

- OECD Guidelines for the Testing of Chemicals No. 423 'Acute Oral Toxicity - Acute Toxic Class Method' (adopted 17 December 2001)

- Method B1 bis Acute Toxicity (Oral) of Commission Regulation (EC) No. 440/2008

Results

Mortality - There were no deaths

Clinical Observations - No signs of systemic toxicity were noted

Bodyweight - All animals showed expected weight gains

Necropsy - No abnormailites were noted

Conclusion

The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be >2500 mg/kg body weight (Globally Harmonized Classification Sysytem - Unclassified).

The test material does not meet the criteria for classification according to EU labelling regulations Commission Directive 2001/59/EC for Classification and Labelling of Dangerous Sbstances or Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.

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