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Short term toxicity to fish

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the closest read across substances, the toxicity to invertebrate was predicted aluminum tris(4-{[3-carboxy-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulf... (CAS: 12225-21-7). Mortality value was estimated to be 386.231 mg/l for Danio rerio for 48 hrs duration. It was concluded that aluminum tris(4-{[3-carboxy-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulf... (CAS: 12225-21-7) was likely to be not toxic  fish and can be considered as "not classified" as per the classification criteria for aquatic environment.

Long term toxicity to fish

According to annex IX of column I , Long-term toxicity testing on fish need not to be conducted as it is already provided as part of Annex VIII requirements.Therefore this study was considered to be waived.

Short term toxicity to aquatic invertebrate

Determination of the inhibition of the mobility of daphnids was carried out with the substanceAluminium,4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex (CAS No12225-21-7)according to OECD Guideline 202.The test substance was tested at the concentrations0, 50, 70, 100, 140, 200mg/L. Effects on immobilisation were observed for 48 hours.

The median effective concentration (EC50) for the test substanceAluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex (CAS No12225-21-7)in Daphnia magna was determined to be 360.4 mg/L for immobilisation effects.

This value indicates that theAluminium,4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex (CAS No12225-21-7)

is likely to be non-hazardous to aquatic invertebrates and can be classified as "not classified" as per the CLP criteria.

Long term toxicity to aquatic invertebrate

According to annex IX of column I ; Long-term toxicity testing on invertebrate (species : Daphnia) need not to be conducted as it is already provided as a part of Annex VII requirements.Therefore this study was considered to be waived.

Toxicity to aquatic algae and cyanobacteria

The effect of test item Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1Hpyrazole-3-carboxylic acid complex, (CAS No. 12225-21-7) was studied on the growth of fresh water green alga Chlorella vulgaris. The study was conducted following OECD guideline 201- Alga, growth inhibition test. The test concentration chosen for the study were 6.25 mg/L,12.5 mg/L,25 mg/L,50 mg/L,100 mg/L,200 mg/L. The test concentrations were prepared using stock solution of the test item using mineral media. The green alga was exposed to the test concentration for a period of 72 hours to observe average specific growth rate and % growth inhibition under the effect of the test item. EC50 calculated graphically through probit analysis was observed to be >200 mg/L. It can be concluded from the value that the Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1Hpyrazole-3-carboxylic acid complex, (CAS No. 12225-21-7) is not toxic to the aquatic algae and can be considered as "not classified" as per the classifiecation criteria for aquatic environment.

Toxicity to micro-organisms

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the closest read across substances, the toxicity to micro-organisms was predicted aluminum tris(4-{[3-carboxy-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulf... (CAS: 12225-21-7). IGC50 (Growth inhibition concentration) value was estimated to be 532.734 mg/l for Tetrahymena pyriformis for 48 hrs duration. It was concluded that aluminum tris(4-{[3-carboxy-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulf... (CAS: 12225-21-7) was likely to be not toxic to micro-organisms.

Additional information

Short term toxicity to fish

Following studies include the predicted data and experimental study for the target chemical and structurally similar read across to conclude the toxicity extent ofaluminum tris(4-{[3-carboxy-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulf... (CAS:12225-21-7)towards fish is summarized as follows:

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the closest read across substances, the toxicity to invertebrate was predicted aluminum tris(4-{[3-carboxy-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulf... (CAS: 12225-21-7). Mortality value was estimated to be 386.231 mg/l for Danio rerio for 48 hrs duration. It was concluded that aluminum tris(4-{[3-carboxy-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulf... (CAS: 12225-21-7) was likely to be not toxic  fish and can be considered as "not classified" as per the classification criteria for aquatic environment.

The above predicted study is supported by the experimental study of read across chemicaldisodium 6-hydroxy-5-[(2-methoxy-3-methyl-4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate(CAS: 25956 -21 -7) from the UERL Lab report 2013, suggests that the Short-term toxicity test was carried out for disodium 6-hydroxy-5-[(2-methoxy-3-methyl-4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate using OECD Guideline 203 (Fish, Acute Toxicity Test) to study the effects on fish.

Mortalities was observed during the test. In a 96 h study for disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate (ALLURA RED AC) on Danio rerio, at a test concentration of 100 mg/L, the fishes were found to be freely swimming in the bowl aquaria without showing any abnormal symptoms. No mortalities were observed at the test concentration of 100 mg/l. No mortalities were found in the control aquaria.

The lethal concentration (LC50) value of disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate (ALLURA RED AC) in fish [Danio rerio] in a 96 hr study on mortality effect was found to be > 100 mg/L.

Thus,considering the CLP Criteria for aquatic classification of the substance , it is concluded that disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-t olyl)azo]naphthalene-2-sulphonate (ALLURA RED AC) does not exhibit short term toxicity to fish [Danio rerio] and can be considered as "not classified" as per the classification criteria for aquatic environment.

Further it is supported by theexperimental study of another structurally similar read across chemicalsodium 4-[(2-hydroxy-1-naphthyl)diazenyl]benzenesulfonate (CAS: 633-96-5) from the handbook 1973 also suggests taht the study was designed to assess the toxic effects of the test compound on the Pimephales promelas in a 96 hr study period. The test was carried out under static condition at temp. 17 (15.1 to 18.4) deg.C, pH : 6.4 to 7.3, dissolved oxygen and Alkalinity : 19 mg/L CaCO3. Mortality was not observed during the test.

The lethal concentration (LC50) value of sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate in fish [Pimephales promelas] in a 96 hr study on the basis of mortality effect was found to be 165 mg/L. Based on this LC50 value and after compairing with CLP criteria for aquatic classification of the substance , it is concluded that sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate does not exhibit short term toxicity to fish (Pimephales promelas) i.e. it is non hazardous to the aquatic environment.

Thus based on the effect concentrations which is in the range > 100 mg/L to 386.231 mg/l give the conclusion that test substance aluminum tris(4-{[3-carboxy-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulf... (CAS:12225-21-7) was likely to be not toxic to fish at environmentally relevant concentrations and can be considered to benot classifiedas per the CLP classification criteria.

 

Long term toxicity to fish

According to annex IX of column I , Long-term toxicity testing on fish need not to be conducted as it is already provided as part of Annex VIII requirements.Therefore this study was considered to be waived.

Short term toxicity to aquatic invertebrate

Data is from the ABITEC Lab 2017,experimental report followed standard gudelinesuggests that theDetermination of the inhibition of the mobility of daphnids was carried out with the substanceAluminium,4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex (CAS No12225-21-7)according to OECD Guideline 202.

The test substance was tested at the concentrations0, 50, 70, 100, 140, 200mg/L. Effects on immobilisation were observed for 48 hours.

The median effective concentration (EC50) for the test substanceAluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex (CAS No12225-21-7)in Daphnia magna was determined to be 360.4 mg/L for immobilisation effects.

This value indicates that theAluminium,4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex (CAS No12225-21-7)

is likely to be non-hazardous to aquatic invertebrates and can be classified as "not classified" as per the CLP criteria.

Long term toxicity to aquatic invertebrate

According to annex IX of column I ; Long-term toxicity testing on invertebrate (species : Daphnia) need not to be conducted as it is already provided as a part of Annex VII requirements.Therefore this study was considered to be waived.

Toxicity to aquatic algae and cyanobacteria

Data is from UERL 2017, exeprimental report followed standard gudeline suggests that The effect of test item Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1Hpyrazole-3-carboxylic acid complex, (CAS No. 12225-21-7) was studied on the growth of fresh water green alga Chlorella vulgaris. The study was conducted following OECD guideline 201- Alga, growth inhibition test. The test concentration chosen for the study were 6.25 mg/L,12.5 mg/L,25 mg/L,50 mg/L,100 mg/L,200 mg/L. The test concentrations were prepared using stock solution of the test item using mineral media. The green alga was exposed to the test concentration for a period of 72 hours to observe average specific growth rate and % growth inhibition under the effect of the test item. EC50 calculated graphically through probit analysis was observed to be >200 mg/L. It can be concluded from the value that the Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1Hpyrazole-3-carboxylic acid complex, (CAS No. 12225-21-7) is not toxic to the aquatic algae and can be considered as "not classified" as per the classifiecation criteria for aquatic environment.

Toxicity to micro-organisms

Following studies include the predicted data and experimental study for the target chemical and structurally similar read across to conclude the toxicity extent ofaluminum tris(4-{[3-carboxy-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulf... (CAS:12225-21-7)towards micro-organisms is summarized as follows:

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the closest read across substances, the toxicity to micro-organisms was predicted aluminum tris(4-{[3-carboxy-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulf... (CAS: 12225-21-7). IGC50 (Growth inhibition concentration) value was estimated to be 532.734 mg/l for Tetrahymena pyriformis for 48 hrs duration. It was concluded that aluminum tris(4-{[3-carboxy-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulf... (CAS: 12225-21-7) was likely to be not toxic to micro-organisms.

The above predicted study is supported by the experimental study of read across chemicaltrisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate (CAS: 1934-21-0) from the publication Toxicology and Applied Pharmacology 1977, suggests that the Toxicity to micro-organsms test was carried for trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate for 0.011 days to study the effcts on micro-organsims.

The lethal time (LT50) value of trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate in microorganism (Paramecium caudatum) on the basis of mortality effect after a 0.011 days exposure period was found to be 10000 mg/L.It can be concluded that the

5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate is not toxic to the micro-organisms.

Further it is supported by theexperimental study of another structurally similar read across chemicaldisodium 6-hydroxy-5-[(4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate (CAS: 2783-94-0) from the publication Journal of Biotechnology 2003, also indicates that The effective concentration (EC50) value of disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate in microorganism (Vibrio fisheri) on the basis of inhibition of the light output after a 5 min exposure period was found to be 22.19+/-2.47 mg/L.

Thus based on the effect concentrations which gives the conclusion that test substance aluminum tris(4-{[3-carboxy-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulf... (CAS:12225-21-7) was likely to be not toxic to micro-organisms at environmentally relevant concentrations.