Registration Dossier
Registration Dossier
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EC number: 223-772-2 | CAS number: 4065-45-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 publication.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Final Report on the Safety Assessment - Test material
- Author:
- COSMETIC INGREDIENT REVIEW
- Year:
- 1 983
- Bibliographic source:
- Journal of the American College of Toxicology
- Reference Type:
- review article or handbook
- Title:
- Acute oral toxicity of test chemical
- Author:
- Richard J. Lewis
- Year:
- 2 012
- Bibliographic source:
- Sax's Dangerous Properties of Industrial Materials
- Reference Type:
- other: authoritative database
- Title:
- Acute oral toxicity by using test chemical
- Author:
- U.S. National Library of Medicine
- Year:
- 2 018
- Bibliographic source:
- ChemIDplus
- Reference Type:
- other: authoritative database
- Title:
- HSDB® Hazardous Substances Data Bank
- Author:
- U.S. National Library of Medicine
- Year:
- 2 014
- Bibliographic source:
- HSDB
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Acute oral toxicity study was conducted by using the given test chemical in rodent.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
Test material
- Reference substance name:
- Sulisobenzone
- EC Number:
- 223-772-2
- EC Name:
- Sulisobenzone
- Cas Number:
- 4065-45-6
- Molecular formula:
- C14H12O6S
- IUPAC Name:
- 5-benzoyl-4-hydroxy-2-methoxybenzenesulfonic acid
- Test material form:
- solid
- Details on test material:
- - Name of test material: Benzenesulfonic acid, 5-benzoyl-4-hydroxy-2-methoxy-
- Molecular formula: C14-H12-O6-S
- Molecular weight: 308.3088 g/mol
- Smiles notation: c1(cc(c(cc1O)OC)S(=O)(=O)O)C(=O)c1ccccc1
- InChl: 1S/C14H12O6S/c1-20-12-8-11(15)10(7-13(12)21(17,18)19)14(16)9-5-3-2-4-6-9/h2-8,15H,1H3,(H,17,18,19)
- Substance type: Organic
- Physical state: Solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Diet (e.g. ad libitum): food, ad libitum
- Water (e.g. ad libitum): water, ad libitum;
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Agar/Tween
- Details on oral exposure:
- not specified
- Doses:
- 1.25 - 10 g/kg
- No. of animals per sex per dose:
- Total = 20
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed and dosed after a one-week observation.Rats were observed daily for 7 to 14 days.
- Necropsy of survivors performed: yes, animals were sacrificed and autopsied for gross pathology. - Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 3 530 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 50% mortality was observed at 3530 mg/kg bw.
- Clinical signs:
- other: Clinical signs was observed such as Ataxia.
- Gross pathology:
- not specified
- Other findings:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- Acute oral toxicity dose (LD50) value was considered to be 3530 mg/kg bw, when rats were treated with the given test chemical via oral route.
- Executive summary:
The acute oral toxicity study was conducted by using the given test chemical in 20 rats at the dose concentration of 1.25 - 10 g/kg via oral route. The given test chemical was dissolved in Agar/Tween. The animals were weighed and dosed after a one-week observation. Rats were observed daily for 7 to 14 days, during which time food and water were allowed ad libitum; in some instances, animals were sacrificed and autopsied for gross pathology. 50% mortality was observed at 3530 mg/kg bw. Clinical signs was observed such as ataxia.
Hence, the LD50 value was considered to be 3530 mg/kg bw, when rats were treated with the given test chemical via oral route.
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