Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
1983
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:
2012
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:
2018
Bibliographic source:
ChemIDplus
Reference Type:
other: authoritative database
Title:
HSDB® Hazardous Substances Data Bank
Author:
U.S. National Library of Medicine
Year:
2014
Bibliographic source:
HSDB

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals 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:
Clinical signs was observed such as Ataxia.
Body weight:
not specified
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.