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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:
secondary literature
Justification for type of information:
Data is from secondary source

Data source

Reference
Reference Type:
secondary source
Title:
OECD SIDS Initial Assessment Report (CAS no. 4404-43-7).
Author:
OECD SIDS – SIAM
Year:
2005
Bibliographic source:
OECD SIDS Initial Assessment Report, SIAM 20, April 2005.

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as below
Principles of method if other than guideline:
Acute oral toxicity study of Benzenesulfonic acid,2-2’-(1,2-ethenediyl)bis(5-((4-(bis(2- hydroxyethyl)amino)-6-(phenylamino)-1,3,5-triazin-2-yl)amino)-, free acid in rat
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4'-bis[4-[bis(2-hydroxyethyl)amino]-6-anilino-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonic acid
EC Number:
224-548-7
EC Name:
4,4'-bis[4-[bis(2-hydroxyethyl)amino]-6-anilino-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonic acid
Cas Number:
4404-43-7
Molecular formula:
C40H44N12O10S2
IUPAC Name:
2,2'-ethene-1,2-diylbis[5-({4-anilino-6-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonic acid]
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2-hydroxyethyl) amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-
- Molecular formula (if other than submission substance): C40H44N12O10S2
- Molecular weight (if other than submission substance): 916.994 g/mole
- Smiles notation (if other than submission substance): c1(nc(Nc2cc(c(\C=C\c3c(cc(Nc4nc(N(CCO)CCO) nc(n4)Nc4ccccc4)cc3)S(O)(=O)=O)cc2)S(O) (=O)=O)nc(n1)Nc1ccccc1)N(CCO)CCO
- InChl (if other than submission substance): 1S/C40H44N12O10S2/c53-21-17-51(18-22-54)39-47-35(41-29-7-3-1-4-8-29)45-37(49-39)43-31-15-13-27(33(25-31)63(57,58)59)11-12-28-14-16-32(26-34(28)64(60,61)62)44-38-46-36(42-30-9-5-2-6-10-30)48-40(50-38)52(19-23-55)20-24-56/h1-16,25-26,53-56H,17-24H2,(H,57,58,59)(H,60,61,62) (H2,41,43,45,47,49)(H2,42,44,46,48,50)/b12-11+
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: organic
- Physical state: solid
- Analytical purity: 89%
- Impurities (identity and concentrations):11%
Specific details on test material used for the study:
- Name of test material (as cited in study report): Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2-hydroxyethyl) amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-
- Molecular formula (if other than submission substance): C40H44N12O10S2
- Molecular weight (if other than submission substance): 916.994 g/mole
- Smiles notation (if other than submission substance): c1(nc(Nc2cc(c(\C=C\c3c(cc(Nc4nc(N(CCO)CCO) nc(n4)Nc4ccccc4)cc3)S(O)(=O)=O)cc2)S(O) (=O)=O)nc(n1)Nc1ccccc1)N(CCO)CCO
- InChl (if other than submission substance): 1S/C40H44N12O10S2/c53-21-17-51(18-22-54)39-47-35(41-29-7-3-1-4-8-29)45-37(49-39)43-31-15-13-27(33(25-31)63(57,58)59)11-12-28-14-16-32(26-34(28)64(60,61)62)44-38-46-36(42-30-9-5-2-6-10-30)48-40(50-38)52(19-23-55)20-24-56/h1-16,25-26,53-56H,17-24H2,(H,57,58,59)(H,60,61,62) (H2,41,43,45,47,49)(H2,42,44,46,48,50)/b12-11+
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: organic
- Physical state: solid

Test animals

Species:
rat
Strain:
Wistar
Remarks:
II
Sex:
female
Details on test animals or test system and environmental conditions:
- Weight at study initiation: 150 - 200 g bw

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 15,000 mg/kg
bw
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: Water
- Lot/batch no. (if required):
- Purity:

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual): 15000 mg/kg bw test substance was dissolved in water (3% solution).
Doses:
15000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data available
- Necropsy of survivors performed: yes/no
- Other examinations performed: Mortality and clinical signs were observed.
Statistics:
Probir analysis (Fink & Hund, Arzenimittelforschung 15, 624, 1965) was used.

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality and clinical sign observed
Mortality:
No mortality was observed in treated female rat at 15000 mg/kg bw
Clinical signs:
other: No clinical sign were observed in treated female rat at 15000 mg/kg bw
Gross pathology:
not specified
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
LD50 was considered to be >15000 mg/kg bw when 10 Wistar II female rat was treated with Benzenesulfonic acid,2-2’-(1,2-ethenediyl)bis(5-((4-(bis(2- hydroxyethyl)amino)-6-(phenylamino)-1,3,5-triazin-2-yl)amino)-, free acid orally by gavage.
Executive summary:

In a acute oral toxicity study, 10 Wistar II female rat was treated with Benzenesulfonic acid,2-2’-(1,2-ethenediyl)bis(5-((4-(bis(2- hydroxyethyl)amino)-6-(phenylamino)-1,3,5-triazin-2-yl)amino)-, free acid in the concentration of 15000 mg/kg bw orally by gavage in water (3 % solution). No mortality and clinical signs were observed in treated female rat at 15000 mg/kg bw.Therefore, LD50 was considered to be >15000 mg/kg bw when 10 Wistar II female rat was treated withBenzenesulfonic acid,2-2’-(1,2-ethenediyl)bis(5-((4-(bis(2- hydroxyethyl)amino)-6-(phenylamino)-1,3,5-triazin-2-yl)amino)-, free acid orally by gavage.