Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
data from handbook or collection of data
Justification for type of information:
Data is from authoritative database.

Data source

Reference
Reference Type:
other: authoritative database
Title:
Acute Oral toxicity of test chemical in Rats.
Author:
U.S. National Library of Medicine
Year:
2017
Bibliographic source:
ChemIDplus, A TOXNET DATABASE, Lite Browse Advanced, 2017.

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Acute oral toxicity study of test chemical in rats.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: 4,4'-(1E,1'E)-(3,3'-dichlorobiphenyl-4,4'-diyl)bis(diazene-2,1-diyl)bis(3-methyl-1-phenyl-1H-pyrazol-5(4H)-one)
InChI:1S/C32H24Cl2N8O2/c1-19-29(31(43)41(39-19)23-9-5-3-6-10-23)37-35-27-15-13-21(17-25(27)33)22-14-16-28(26(34)18-22)36-38-30-20(2)40-42(32(30)44)24-11-7-4-8-12-24/h3-18,43-44H,1-2H3/b37-35+,38-36+
Smiles: Cc1nn(c(O)c1N=Nc2ccc(cc2Cl)c3ccc(N=Nc4c(C)nn(c4O)c5ccccc5)c(Cl)c3)c6ccccc6
- Name of test material (as cited in study report):Pigment Orange 13
- Molecular formula :C32H24Cl2N8O2
- Molecular weight :623.5016 g/mol
- Substance type:organic

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
not specified
Control animals:
not specified
Details on study design:
not specified
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No Mortality was observed
Mortality:
No Mortality was observed in treated rats at 5000 mg/kg bw.
Clinical signs:
not specified
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The lethal concentration (LD50) value for acute oral toxicity test was considered to be >5000 mg/kg bw, when rats were treated with test chemical via oral route.
Executive summary:

Acute oral toxicity study was conducted using test chemical in rats at the concentration of 5000 mg/kg bw. Animals were observed for mortality. No Mortality was observed at dose 5000 mg/kg bw. Hence, LD50 value was considered to be >5000 mg/kg bw, when rats were treated with test chemical via oral route.