Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short term toxicity of aquatic invertebrates:

Determination of the inhibition of the mobility of daphnids was carried out with the substance 2,7-Naphthalenedisulfonic acid, 3-hydroxy- 4-[(4-sulfo-1-naphthalenyl), sodium salt; Amaranth dye according to OECD Guideline 202. The limit test wasperformed at 100 mg/l. Effects on immobilisation were observed for 48 hours. The effective concentration (EC8) for the test substance, 2,7-Naphthalenedisulfonic acid, 3-hydroxy-4- [(4-sulfo-1 -naphthalenyl), sodium salt (Amaranth dye), in Daphnia magna was determined to be 100 mg/L on the basis of mobiity inhibition effects in a 48 hour study. This value indicates that the substance is likely to be non-hazardous to aquatic invertebrates and can not be classified as toxic as per the CLP criteria.

Toxicity to algae and cyanobacteria:

Freshwater algal growth inhibition test was carried out on Desmodesmus subspicatus with the substance 2,7-Naphthalenedi- sulfonic acid, 3-hydroxy-4-[(4-sulfo- 1-naphthal - enyl), sodium salt (Amaranth dye) according to OECD Guideline 201. The test substance was dissolved in OECD growth medium and tested at the concentrations 0, 12.5, 25, 50, 100, 200 mg/L. Effects on the growth rate of the organism were studied. The effective concentration (ErC50) for the test substance, 2,7-Naphthalen -edisulfonic acid, 3-hydroxy-4-[(4-sulfo-1- -naphthalenyl), sodium salt, in Desmodesmus subspicatus was determined to be 356.2 mg/L. This value indicates that the substance is likely to be non-hazardous to aquatic algae and cannot be classified as toxic as per the CLP criteria.

 

Additional information

Summarized results of toxic effect of the chemical (7-Hydroxy-8-((4-sulpho-1-naphthyl) azo) naphtha- alene-1,3-disulphonato(3-))aluminium (15876-47-8) on the growth and other normal activities of aquatic life, by the collection of data from various databases for the read across chemical which was highly similar to the target chemical, are as summarized:

 

Short term toxicity of aquatic invertebrates:

Based on the various data for the read across chemical (915-67-3), and (4548-53-2) which was structurally and chemically more similar to the target chemical (7-Hydroxy-8- ((4-sulpho-1-naphthyl) azo) naphtha- alene-1,3-disulphonato(3-))aluminium (15876-47-8)l various studies has been reviewed to check the toxic nature of the target chemical on the growth and other activity of the aquatic life:

 

In the first experimental weight of evidence study for RA chemical 2,7Naphthalenedisulfonic acid, 3-hydroxy- 4-[(4-sulfo-1-naphthalenyl), sodium salt (Amaranth dye) (915-67-3), ABITEC lab report, 2016. Determination of the inhibition of the mobility of daphnids was carried out with the substance 2,7-Naphthalene -disulfonic acid, 3-hydroxy- 4-[(4-sulfo- 1-naphthalenyl), sodium salt; Amaranth dye according to OECD Guideline 202. The limit test was performed at 100 mg/l. Effects on immobilisation were observed for 48 hours. The effective concentration (EC8) for the test substance, 2,7-Naphthalenedisulfonic acid, 3-hydroxy-4- [(4-sulfo-1 -naphthalenyl), sodium salt (Amaranth dye), in Daphnia magna was determined to be 100 mg/L on the basis of mobility inhibition effects in a 48 hour study. This value indicates that the substance is likely to be non-hazardous to aquatic invertebrates and cannot be classified as toxic as per the CLP criteria.

 

Similarly in the second experimental weight of evidence study for RA chemical Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl) azo]-4-hydroxy naphthalene-1-sulphonate (4548-53-2) ABITEC report, 2016. Determination of the inhibition of the mobility of daphnids was carried out with the substance Disodium 3-[(2,4-dimethyl-5- sulphonatophenyl) azo]-4-hydroxy naphthalene-1-sulphonateaccording to OECD Guideline 202. A limit test at sample concentration of 100 mg/L was performed. Effects on immobilisation were observed for 48 hours. The median effective concentration (EC50) for the test substance, Disodium 3-[(2,4-dimethyl-5-sulphonato -phenyl)azo]-4-hydroxynaphthalene-1-sulphonate, in Daphnia magna was determined to be >100 mg/L for immobilisation effects. Based on this EC50 value and after comparing with CLP criteria for aquatic classification of the substance it is concluded that the substance, disodium 3-[(2,4-dimethyl-5-sulphonatophenyl) azo]- 4-hydroxynaphthalene-1-sulphonate does not exhibit short term toxicity to aquatic invertebrate (Daphnia Magna).

 

Similarly in the third weight of evidence study for RA chemical 2,7-Naphthalenedisulfonic acid, 3-hydroxy- 4-[(4-sulfo-1-naphthalenyl), sodium salt (Amaranth dye) (915-67-3), The Journal of Toxicological Sciences, 1997. The toxic effects of Amaranth were studied on Artemia salina larvae. Artemia salina (A. salina eggs) a crustacean, commonly known as brine shrimp eggs, are commercially available, and are easily cultured in the laboratory because they are resistant to environmental stresses. Active larvae can be obtained within 1 to 2 days and no live culture is required for a few days thereafter. A. salina eggs (encysted dried gastrulae) were commercially obtained, and were stored at -200°C. Eggs used in experiments were washed and stored at room temperature in a desiccators over anhydrous granular CaCl2. Larvae were obtained by incubating eggs in petri dishes containing muslin-filtered sea water at 30°C for 24 hours. The larvae were separated from shells, dead larvae and unhatched eggs by their phototactic movements towards a light source. Amaranth at concentrations of 6044.7mg/l and 604.47 mg/l were placed in a petri dish, and sea water containing 20 to 30 larvae was added. After this was incubated at 30°C for 24 hours and 48 hours, larvae surviving were measured by direct count. The same method was tested from 5 to 6 times for each concentration, and the death rate was calculated. Death was assumed to have occurred when there was no movement. The death rate was defined as the average of the percentage of deaths observed for 24 hours and 48 hours. 100% death rate was noted after 48 hours when 6044.7 mg/l of Amaranth was exposed to the test organism and 0% death rate after 24 hours in case of exposure to 604.47 mg/l of test chemical.

 

Based on the above RA cas which was structurally and chemically more similar to the target chemical data obtain from various databases, from the sources it was concluded that the (7-Hydroxy-8-((4-sulpho-1-naphthyl) azo) naphtha- alene-1,3-disulphonato(3-)) aluminium does not exhibit toxicity to aquatic invertebrates. Hence the test chemical is not likely to classify as a toxic as per the criteria mentioned in CLP regulation.

 

Toxicity to algae and cyanobacteria:

Based on the various data for the read across chemical (915-67-3), and (4548-53-2) which was structurally and chemically more similar to the target chemical (7-Hydroxy-8- (4-sulpho-1-naphthyl) azo) naphtha- alene-1,3-disulphonato(3-))aluminium (15876-47-8)l various studies has been reviewed to check the toxic nature of the target chemical on the growth and other activity of the aquatic life:

 

In the first weight of evidence study for RA chemical 2,7-Naphthalenedisulfonic acid, 3-hydroxy- 4-[(4-sulfo-1-naphthalenyl), sodium salt (Amaranth dye) (915-67-3), ABITEC lab report, 2016. Freshwater algal growth inhibition test was carried out on Desmodesmus subspicatus with the substance 2,7-Naphthalenedi- sulfonic acid, 3-hydroxy-4-[(4-sulfo- 1-naphthal - enyl), sodium salt (Amaranth dye) according to OECD Guideline 201. The test substance was dissolved in OECD growth medium and tested at the concentrations 0, 12.5, 25, 50, 100, 200 mg/L. Effects on the growth rate of the organism were studied. The effective concentration (ErC50) for the test substance, 2,7-Naphthalen -edisulfonic acid, 3-hydroxy-4-[(4-sulfo-1- -naphthalenyl), sodium salt, in Desmodesmus subspicatus was determined to be 356.2 mg/L. This value indicates that the substance is likely to be non-hazardous to aquatic algae and cannot be classified as toxic as per the CLP criteria.

 

Similarly in the second experimental weight of evidence study for RA chemical Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl) azo]-4-hydroxy naphthalene-1-sulphonate (4548-53-2) ABITEC report, 2016. Freshwater algal growth inhibition test was carried out on Desmodesmus subspicatus with the substance Disodium 3-[(2,4-dimethyl -5-sulphonatophenyl) azo]-4-hydroxynaphthalene-1-sulphonate according to OECD Guideline 201. The test substance was dissolved in OECD growth medium and tested at the concentrations 0, 0, 12.5, 25, 50, 100 and 200 mg/L. Effects on the growth rate of the organism were studied. The median effective concentration (ErC50) for the test substance, Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate, in Desmodesmus subspicatus was determined to be 276.1 mg/L. Based on this ErC50 value and after comparing with CLP criteria for aquatic classification of the substance it is concluded that the substance Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate does not exhibit toxicity to aquatic algae (Desmodesmus subspicatus).

 

Based on the above RA cas which was structurally and chemically more similar to the target chemical data obtain from various databases, from the sources it was concluded that the (7-Hydroxy-8-((4-sulpho-1-naphthyl) azo) naphtha- alene-1,3-disulphonato(3-)) aluminium does not exhibit toxicity to aquatic algae and cyanobacteria. Hence the test chemical is not likely to classify as a toxic as per the criteria mentioned in CLP regulation.

 

Based on the above RA cas which was structurally and chemically more similar to the target chemical data obtain from various databases, from the sources it was concluded that the (7-Hydroxy-8-((4-sulpho-1-naphthyl) azo) naphtha- alene-1,3-disulphonato(3-)) aluminium does not exhibit toxicity to aquatic invertebrates, algae and cyanobacteria. Hence the test chemical is not likely to classify as a toxic as per the criteria mentioned in CLP regulation.