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Description of key information

Acute oral toxicity:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS no.: 84057-71-6). The studies are as mentioned below:

WoE 2:

Acute oral toxicity study was conducted in rats using test material at the concentration of 7460 mg/kg bw. 50% mortality was observed at dose 7460 mg/kg bw. Hence, LD50 value was considered to be 7460 mg/kg bw, when rats were treated with test chemical via oral route.

WoE 3:

Acute oral toxicity study was conducted in rats using test material at the dose concentration of 8980 mg/kg bw. 50% mortality was observed at dose 8980 mg/kg bw. Hence, LD50 value was considered to be 8980 mg/kg bw, when rats were treated with test chemical via oral route.

Thus, based on the above summarised studies, Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS no.: 84057-71-6) and it’s structurally and functionally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS no.: 84057-71-6) cannot be classified for acute oral toxicity. Hence, Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl] phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) is not toxic for acute oral toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
experimental data of read across substances
Justification for type of information:
Data for the target chemical is summarized based on the structurally and functionally similar read across chemicals
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
WoE report is based on 2 acute oral toxicity studies as - WoE-2 and WoE-3.
Acute Oral toxicity test was carried out to study the effects of the test chemicals on rodents.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Specific details on test material used for the study:
Name: Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo] -4-sulphobenzoato(6-)]cuprate(4-)
Smiles:[H+].CCN1c2cccc(c2)S(=O)(=O)CCOS(=O)(=O)O[Cu-4]3456C(/N=N/c7cc(ccc7C(=O)O3)S(=O)(=O)O4)(N=Nc8cc(cc(c8O5)Nc9nc1nc(n9)Cl)S(=O)(=O)O6)c1ccccc1.[Na+].[Na+].[Na+]
InChI:1S/C33H29ClN9O15S4.Cu.3Na/c1-2-43(20-9-6-10-21(15-20)59(47,48)14-13-58-62(55,56)57)33-37-31(34)36-32(38-33)35-26-17-23(61(52,53)54)18-27(28(26)44)40-42-29(19-7-4-3-5-8-19)41-39-25-16-22(60(49,50)51)11-12-24(25)30(45)46;;;;/h3-12,15-18,44H,2,13-14H2,1H3,(H,45,46)(H,49,50,51)(H,52,53,54)(H,55,56,57)(H,35,36,37,38);;;;/q;4*+1/p-4/b41-39+,42-40+;;;;
Molecular Weight: 1083.8415 g/mole
Molecular FormulaL C33H24ClCuN9O15S4.H.3Na
Substance type: Organic
Species:
rat
Strain:
other: 1. not specified 2. not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
1. not specified
2. not specified
Route of administration:
other: 1. oral: unspecified 2. oral: unspecified
Vehicle:
other: 1. not specified 2. not specified
Details on oral exposure:
1. not specified
2. not specified
Doses:
1. 7460 mg/kg bw
2. 8980 mg/kg bw
No. of animals per sex per dose:
1. not specified
2. not specified
Control animals:
not specified
Details on study design:
1. not specified
2. not specified
Statistics:
1. not specified
2. not specified
Preliminary study:
1. not specified
2. not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
7 460 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50% mortality was observed
Sex:
not specified
Dose descriptor:
LD50
Effect level:
8 980 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50% mortality was observed
Mortality:
1. 50% mortality was observed at dose 7460 mg/kg bw
2. 50% mortality was observed at dose 8980 mg/kg bw
Clinical signs:
1. not specified
2. not specified
Body weight:
1. not specified
2. not specified
Gross pathology:
1. not specified
2. not specified
Other findings:
1. not specified
2. not specified
Interpretation of results:
other: Not classified
Conclusions:
According to CLP regulation the test chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl] azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS no.: 84057-71-6) cannot be classified for acute oral toxicity, as the LD50 value is >2000 mg/kg bw and in the range of 7460-8980 mg/kg bw.
Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS no.: 84057-71-6). The studies are as mentioned below:

1. Acute oral toxicity study was conducted in rats using test material at the concentration of 7460 mg/kg bw. 50% mortality was observed at dose 7460 mg/kg bw. Hence, LD50 value was considered to be 7460 mg/kg bw, when rats were treated with test chemical via oral route.

2. Acute oral toxicity study was conducted in rats using test material at the dose concentration of 8980 mg/kg bw. 50% mortality was observed at dose 8980 mg/kg bw. Hence, LD50 value was considered to be 8980 mg/kg bw, when rats were treated with test chemical via oral route.

Thus, based on the above summarised studies, Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS no.: 84057-71-6) and it’s structurally and functionally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS no.: 84057-71-6) cannot be classified for acute oral toxicity. Hence, Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl] phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) is not toxic for acute oral toxicity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
8 980 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from authoritative database.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS no.: 84057-71-6). The studies are as mentioned below:

WoE 2:

Acute oral toxicity study was conducted in rats using test material at the concentration of 7460 mg/kg bw. 50% mortality was observed at dose 7460 mg/kg bw. Hence, LD50 value was considered to be 7460 mg/kg bw, when rats were treated with test chemical via oral route.

WoE 3:

Acute oral toxicity study was conducted in rats using test material at the dose concentration of 8980 mg/kg bw. 50% mortality was observed at dose 8980 mg/kg bw. Hence, LD50 value was considered to be 8980 mg/kg bw, when rats were treated with test chemical via oral route.

Thus, based on the above summarised studies, Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS no.: 84057-71-6) and it’s structurally and functionally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS no.: 84057-71-6) cannot be classified for acute oral toxicity. Hence, Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl] phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) is not toxic for acute oral toxicity.

Justification for classification or non-classification

Based on the above experimental studies on Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS no.: 84057-71-6) and it’s structurally and functionally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) cannot be classified for acute oral toxicity.