Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary source.

Data source

Reference
Reference Type:
other: secondary source
Title:
SIDS INITIAL ASSESSMENT REPORT
Author:
OECD SIDS
Year:
1996
Bibliographic source:
SIDS INITIAL ASSESSMENT REPORT

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Acute oral toxicity study for the given test chemical.
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:
- IUPAC Name: 4,4'-diaminostilbene-2,2'-disulphonic acid
- Mol. formula: C14H14N2O6S2
- Molecular Weight: 370.405 g/mole
- InChI: InChI=1S/C14H14N2O6S2/c15-11-5-3-9(13(7-11)23(17,18)19)1-2-10-4-6-12(16)8-14(10)24(20,21)22/h1-8H,15-16H2, (H,17,18,19)(H,20,21,22)/b2-1+
- Smiles: Nc1ccc(\C=C\c2ccc(N)cc2S(=O)(=O)O)c(c1)S(=O)(=O)O

Test animals

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

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
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:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed
Clinical signs:
No symptoms
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 LD50 value was considered to be >5000 mg/kg bw, when Wistar male 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 Male Wistar rats at the concentration of 5000 mg/kg bw. Animals were observed for mortality and signs of toxicity. No mortality and clinical symptoms were observed. Hence, the LD50 value was considered to be >5000 mg/kg bw, when Wistar male rats were treated with the given test chemical via oral route.