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Acute Toxicity: dermal

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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:
2018
Bibliographic source:
ChemIDplus
Reference Type:
publication
Title:
The overall toxic action of the test chemical
Author:
Berezovskaya et al.
Year:
1978
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

Constituent 1
Chemical structure
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

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.