Registration Dossier
Registration Dossier
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EC number: 203-157-5 | CAS number: 103-90-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data from publication
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Analgesic potency and acute toxicity of substituted anilides and benzamides
- Author:
- G.A. Starmera, b, S. McLeana, b, J. Thomasa, b
- Year:
- 1 971
- Bibliographic source:
- Toxicology and Applied Pharmacology. Vol. 19, Pg. 20, 1971.
- Reference Type:
- publication
- Title:
- No information
- Author:
- Koch, H. P. et al
- Year:
- 1 993
- Bibliographic source:
- Meth. Find. Exp. Clin. Pharmacol. 1993, 15(3), 141-152.
- Reference Type:
- review article or handbook
- Title:
- DPIM : HIM000
- Author:
- Richard J. Lewis, Sr.
- Year:
- 2 007
- Bibliographic source:
- SAX (Sax's Handbook of Dangerous Industrial Materials); Toxicology and Applied Pharmacology. 18 (1971), 185.
- Reference Type:
- review article or handbook
- Title:
- RTECS Number : AE4200000
- Author:
- RTECS database
- Year:
- 2 012
- Bibliographic source:
- RTECS (Registry of Toxic Effects of Chemical Substances); TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year: 19,20,1971
- Reference Type:
- other: Authoritative data base
- Title:
- GCID : 11064
- Author:
- ACToR database
- Year:
- 2 011
- Bibliographic source:
- ACToR (Aggregated Computational Toxicology Resource): Toxicology and Applied Pharmacology. Vol. 19, Pg. 20, 1971.
- Reference Type:
- review article or handbook
- Title:
- DOSE Doc.no : P6
- Author:
- RSC Publishing
- Year:
- 2 011
- Bibliographic source:
- Dictionary of Substances and their effects (DOSE);Koch, H. P. et al Meth. Find. Exp. Clin. Pharmacol. 1993, 15(3), 141-152.
- Reference Type:
- other: Authoritative data base
- Title:
- HSDB Number : 3001
- Author:
- HSDB Database
- Year:
- 2 011
- Bibliographic source:
- HSDB (Hazardous Substances Data Bank); US national Library of Medicine reviewed by SRC:Lewis, R.J. Sr. (ed) Sax's Dangerous Properties of Industrial Materials. 11th Edition. Wiley-Interscience, Wiley & Sons, Inc. Hoboken, NJ. 2004.p.1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- The acute oral toxicity and analgesic potency, in mice, of Paracetamol have been determined.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Paracetamol
- EC Number:
- 203-157-5
- EC Name:
- Paracetamol
- Cas Number:
- 103-90-2
- Molecular formula:
- C8H9NO2
- IUPAC Name:
- .
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name of test material (as cited in study report): Paracetamol
Substance type: Organic
Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:No data
- Expiration date of the lot/batch:No data
- Purity test date:No data
RADIOLABELLING INFORMATION (Not applicable)
- Radiochemical purity: N/A
- Specific activity:N/A
- Locations of the label:N/A
- Expiration date of radiochemical substance:N/A
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:No data
- Stability under test conditions:No data
- Solubility and stability of the test substance in the solvent/vehicle:No data
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:No data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:The compounds were reduced to fine powder, suspended in 1% methylcellulose mucilage, and the mixture was homogenized.
- Preliminary purification step (if any):No data
- Final dilution of a dissolved solid, stock liquid or gel:No data
- Final preparation of a solid:No data
Test animals
- Species:
- mouse
- Strain:
- other: QS strain
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation:18-22 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% methylcellulose mucilage, and the mixture was homogenized
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: volume of 0.5 ml/20 g
- No. of animals per sex per dose:
- 20 female mice
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: Deaths were counted after 48 hr.
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: No data - Statistics:
- LD50 and confidence limits were calculated by the method of Litchfield and Wilcoxon.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 338 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 306 - 373
- Mortality:
- Not reported
- Clinical signs:
- other: Not reported
- Gross pathology:
- Not reported
- Other findings:
- - Other observations: Analgesic Activity : 4-Hydroxyacetanilide (paracetamol) was only weakly active as an analgesic, which was somewhat surprising in view of its widespread clinical use.The analgestic toxicity was found to be 22% observed with the help of hotplate test.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of Paracetamol,when administered to mouse was found to be 338 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that Paracetamol exhibits acute toxicity by the oral route in “Category 4”.
- Executive summary:
The acute oral median lethal dose (LD50) of Paracetamol,when administered to mouse was found to be 338 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that Paracetamol exhibits acute toxicity by the oral route in “Category 4”.
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