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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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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:
other: Data is from Chemicals Challenge Program

Data source

Reference
Reference Type:
secondary source
Title:
Stilbene Intermediates Category, HPV Challenge Program, Test Plan and Category Justification
Author:
ETAD Fluorescent Whitening Agent Task Force
Year:
2005
Bibliographic source:
U.S. Environmental Protection Agency Under the High Production Volume (HPV) Chemicals Challenge Program, 2005

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Acute oral toxicity of 4,4' -diamino-2,2'stilbenedisulfonic acid in rats
GLP compliance:
not specified
Test type:
other: No data
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 4,4'-diaminostilbene-2,2'-disulphonate
EC Number:
230-847-3
EC Name:
Disodium 4,4'-diaminostilbene-2,2'-disulphonate
Cas Number:
7336-20-1
Molecular formula:
C14H14N2O6S2.2Na
IUPAC Name:
disodium 2,2'-ethene-1,2-diylbis(5-aminobenzenesulfonate)
Constituent 2
Reference substance name:
4,4' -diamino-2,2'stilbenedisulfonic acid
IUPAC Name:
4,4' -diamino-2,2'stilbenedisulfonic acid
Details on test material:
- Name of test material (as cited in study report): 4,4' -diamino-2,2'stilbenedisulfonic acid
- Molecular formula (if other than submission substance): C14H14N206S2.2Na
- Molecular weight (if other than submission substance): 414.37 g/mole
- Substance type: Organic

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
- Weight at study initiation: 160 – 180 g
- Housing: Animals were housed 5 per cage

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
No data available
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 male
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
No data available

Results and discussion

Preliminary study:
No data available
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
No mortality observed in treated rats.
Clinical signs:
other: No signs of toxicity were observed in treated male rats.
Gross pathology:
No data available
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
LD50 was considered to be > 5000 mg/kg bw when Wistar male rats were 4,4' -diamino-2,2'stilbenedisulfonic acid orally by gavage.
Executive summary:

In Acute oral toxicity study, Wistar male rats treated with 4,4' -diamino-2,2'stilbenedisulfonic acid in the concentration of 5000 mg/kg bw orally by gavage and observed for 14 days. No mortality and signs of toxicity observed in treated male rats. Therefore, LD50 was considered to be >5000 mg/kg bw when Wistar male rats were 4,4' -diamino-2,2'stilbenedisulfonic acid orally by gavage.