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EC number: 204-526-3 | CAS number: 122-18-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from authoritative database.
Data source
Referenceopen allclose all
- Reference Type:
- other: authoritative database
- Title:
- Acute Dermal toxicity - Test chemical
- Author:
- U.S. National Library of Medicine
- Year:
- 2 018
- Bibliographic source:
- ChemIDplus
- Reference Type:
- publication
- Title:
- The overall toxic action of the test chemical
- Author:
- Berezovskaya et al.
- Year:
- 1 978
- Bibliographic source:
- Pharmaceutical Chemistry Journal
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Acute Dermal toxicity study of the given test chemical in Rat.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
Test material
- Reference substance name:
- Quaternary ammonium compounds, benzyl-C8-18-alkyldimethyl, chlorides
- EC Number:
- 264-151-6
- EC Name:
- Quaternary ammonium compounds, benzyl-C8-18-alkyldimethyl, chlorides
- Cas Number:
- 63449-41-2
- IUPAC Name:
- N-benzyl-N,N-dimethyldecan-1-aminium chloride
- Details on test material:
- - IUPAC Name: Quaternary ammonium compounds, benzyl-C8-18-alkyldimethyl, chlorides
- Common Name: Benzalkonium chloride
- InChI: 1S/C19H34N.ClH/c1-4-5-6-7-8-9-10-14-17-20(2,3)18-19-15-12-11-13-16-19;/h11-13,15-16H,4-10,14,17-18H2,1-3H3;1H/q+1;/p-1
- Smiles: [Cl-].CCCCCCCCCC[N+](C)(C)Cc1ccccc1
- Molecular weight :311.9376 g/mol
- Substance type:Organic
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: white rats
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Type of coverage:
- other: Dermal
- Vehicle:
- other: Aqueous solution
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Shaved skin of the stomach
- % coverage: 4 cm2 in area - Duration of exposure:
- 4-day exposure
- Doses:
- Range of 1224-1647 mg/kg
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Details on study design:
- - Other examinations performed: Animals were observed for clinical signs.
- Statistics:
- Calculation of the mean lethal dose (LD50) was carried out by the probit analysis method of Litchfield and Wilcoxon.
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 1 420 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 224 - 1 647
- Remarks on result:
- other: 50% mortality was observed
- Mortality:
- 50% mortality was observed at 1420 mg/kg bw.
- Clinical signs:
- Behavioral changes were observed such as, somnolence (general depressed activity) and hemorrhage was observed.
- Body weight:
- not specified
- Gross pathology:
- not specified
- Other findings:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute Dermal LD50 value was considered to be 1420 mg/kg bw, with 95% confidence limit of 1224-1647 mg/kg bw, when white rats were treated with the given test chemical by dermal application.
- Executive summary:
Acute Dermal toxicity study of the given test chemical was conducted in white rats at the concentration range of 1224-1647 mg/kg bw. The given test chemical was applied as aqueous solutions to the shaved skin of the stomach of white rats 4 cm2 in area with a 4-day exposure. Animals were observed for clinical signs. Calculation of the mean lethal dose (LD50) was carried out by the probit analysis method of Litchfield and Wilcoxon. 50% mortality was observed at 1420 mg/kg bw. Behavioural changes were observed such as, somnolence (general depressed activity) and haemorrhage was observed. Hence, LD50 value was considered to be 1420 mg/kg bw, with 95% confidence limit of 1224-1647 mg/kg bw, when white rats were treated with the given test chemical by dermal application.
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