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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:
January to February 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
We believe the results are correct but due to their age detail is brief and there is no indication of GLP compliance. However the report was accepted by the quality assurance unit of the testing house as being an accurate presentation of the findings of the study at the time.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
A 10%w/v solution of the test substance was administered by oral intubation at arange of dosage volume of 4 -40ml/Kg body weight. control rats
were treated with distilled water alone at a dosage of 40ml/Kg bodyweight
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Reference substance name:
1,3 Cyclohexanedione
IUPAC Name:
1,3 Cyclohexanedione
Details on test material:
- 1,3 Cyclohexanedione
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state:
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material:
- Other:

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 91 to 129 gm
- Fasting period before study: Overnight





Administration / exposure

Route of administration:
other: oral intubation
Vehicle:
water
Remarks:
distilled
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10% w/v
- Amount of vehicle (if gavage): 4 to 40ml/Kg bodyweight
- Justification for choice of vehicle: Test substance solubility
- Lot/batch no. (if required):
- Purity:

MAXIMUM DOSE VOLUME APPLIED: 4gm/Kg bodyweight

Doses:
0.4gm to 4.0gmof test substance per Kg of bodyweight
No. of animals per sex per dose:
2 males and 2 females per dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: All animals surviving terminally were examined macroscopically to detect possible residual damage
- Other examinations performed: clinical signs and body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 1 600 - <= 2 500 mg/kg bw
Based on:
test mat.
Mortality:
See attached full study report
Clinical signs:
other: See attached full study report
Gross pathology:
See attached full study report
Other findings:
See attached full study report

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute median lethal oral dose (LD50) to rats of 1,3 - cyclohexanedione was found to be between 1.6 and 2.5g/Kg bodyweight
Executive summary:

The acute oral toxicity of 1,3 - Cyclohexanedione to rats was determined by oral intubation of a range of dosages of a 10%w/v test solution. The dosage volume range was 4.0 to 40ml/Kg bodyweight. The observation period was 14 days during which time a record was kept of all mortalities and signs of mortality. The acute median lethal oral dose (LD50) to rats of 1,3 - cyclohexanedione was found to be between 1.6 and 2.5g/Kg bodyweight