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Diss Factsheets

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:
Feb- Mar 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
446-620-9
EC Name:
-
Cas Number:
120983-72-4
Molecular formula:
Hill formula: C5H6Cl2O CAS formula: C5H6Cl20
IUPAC Name:
2-chloro-1-(1-chlorocyclopropyl)ethan-1-one
Test material form:
liquid
Details on test material:
purity: 92.3 %
Specific details on test material used for the study:
Purity: 92.1 %
Identity/Stability in the vehicle confirmed analytically.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
5 ml/ kg BW
Doses:
male: 25 and 200 mg/kg bw
female: 25, 200 and 2000 mg/kg bw
No. of animals per sex per dose:
5 anmials per sex and dose
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 50 - < 200 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 50 - < 200 mg/kg bw
Based on:
test mat.
Mortality:
At 200 mg/kg two males and two females, and at 2,000 mg/kg two females died during the study.
Clinical signs:
other: A dose of 25 mg/kg body weight was tolerated by male and female rats without mortalities and clinical signs. At 200 mg/kg in both sexes piloerection, constipation, decreased motility, decreased reactivity, labored breathing, and in females pallor and unco
Gross pathology:
In animals that died during the observation period the following changes were
detected:
Liver: pale and dark-red discolorations; distinct tabulation;
Lung: slightly collapsed;
Spleen: pale discoloration;
Kidneys: pale discoloration;
Forestomach: thickened; adhesion to abdominal wall;
General observations: autolysis

Animals killed at the end of the study period showed the following changes:
Body cavity: adhesions of stomach (forestomach), and liver to abdominal wall
Liver: pale discoloration; adhesions to forestomach
Stomach: adhesions of forestomach to abdominal wall, forestomach thickened
Spleen: adhesions
Kidneys: pale discoloration

Any other information on results incl. tables
















































Dose [mg/kg b.w.]



Toxicological results


 



Duration of signs



Time of death



Mortality


[%]



 



a)



b)



c)



males



 



 



25



0



0



3



-



-



0



200



2



3



3



5h        - 10d



3d        - 6d



67



 



 



 



 



females



 



 


































25



0



0



3



-



-



0



200



2



3



3



5h        - 13d



8d



67



2,000



2



3 -



3



5'        - 14d



2d



67




  1. number of dead animals

  2. number of animals with signs

  3. number of animals in the group

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
LD50: >50 <200 mg/kg body weight
Executive summary:

A study for acute oral toxicity in male and female Wistar rats was conducted with the test substance JAU 6476 - Chloromethylketone.
The method used complied with the OECD - Guideline for Testing of Chemicals No. 423.


A dose of 25 mg/kg body weight was tolerated by male and female rats without mortalities, clinical signs, effects on weight development and gross pathological findings.
At 200 mg/kg in both sexes piloerection, constipation, decreased motility, decreased reactivity, labored breathing, and in females pallor and uncoordinated gait were observed. Additionally to the above described signs, at 2000 mg/kg in females increased motility, increased salivation and in one animal abdominal position were observed. The signs observed occurred within 5 minutes after administration and lasted up to day 14 of the study. 200 mg/kg and 2000 mg/kg were lethal. At 200 mg/kg two males and two females, and at 2000 mg/kg two females died during the study.
The treatment induced a clear body weight depression on day 8 of the study at 200 mg/kg and above. The gross pathology investigations performed at the end of the post-treatment observation period showed pale discolorations on liver, thickened forestomach, pale discolorations on kidneys, and adhesions in the abdominal cavity, where liver, forestomach, spleen and abdominal wall were adhered.