reaction mass of: tetrasodium 7-(4-(4-fluoro-6-(4-(2-sulfonatoethylsulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate;tetrasodium 7-(4-(4-hydroxy-6-(4-(2-sulfonatoethylsulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate

GHS

General Information

Not classified

Implementation:

EU

Type of classification:

self-classification

Remarks:

This substance was classified under Directive 67/548/EEC as 'Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment' (R52-53) due to the result an algal study. However it should be noted that under REACH regulation, there have been some alterations to the manner in which Algal data is interpreted. It is known that the following is applicable:

1. In algal studies, the result based on growth rate shall be used for evaluation instead of those for biomass. Thus, the result of the algae study is ErC50 >87 mg/L (measured). However there is no reason to recalculate nominal concentrations with measured concentrations as long as the result of the analytical monitoring is >80% of the nominal concentration. For this reason, the actual result which should be reported within this registration under REACH should be ErC50 >100 mg/L (nominal).


2. The decrease of growth rate at the highest concentration (87/100 mg/L) was given as 23%. A further examination of the probit analysis has been undertaken by an independent consultant whom has extrapolated the original values with ToxRat (version 2.10.05), Weibull distribution.
   The results of this assessment are as follows:
   Based on nominal concentrations: ErC50 = 175 mg/L (95%CV: lower 145 mg/L, higher 253 mg/L).
   Based on measured concentrations: ErC50 = 152 mg/L (95%CV: lower 125 mg/L, higher 221 mg/L).


3. As such, these revised values indicate that classification as R52-53 is no longer applicable. The substance is therefore proposed to be “not classified” for environmental effects under regulation (EC) No 1272/2008.

A respective change of the harmonised classification will be addressed in a CLH dossier.

Related composition

Related composition:

Sameness

Legal Entity Composition

Classification

Physical hazards

Explosives

Reason for no classification:

data conclusive but not sufficient for classification

Flammable gases and chemically unstable gases

Reason for no classification:

data conclusive but not sufficient for classification

Aerosols

Reason for no classification:

data conclusive but not sufficient for classification

Reason for no classification:

hazard class not assessed

Oxidising gases

Reason for no classification:

data conclusive but not sufficient for classification

Gases under pressure

Reason for no classification:

data conclusive but not sufficient for classification

Flammable liquids

Reason for no classification:

data conclusive but not sufficient for classification

Flammable solids

Reason for no classification:

data conclusive but not sufficient for classification

Self-reactive substances and mixtures

Reason for no classification:

data conclusive but not sufficient for classification

Pyrophoric liquids

Reason for no classification:

data conclusive but not sufficient for classification

Pyrophoric solids

Reason for no classification:

data conclusive but not sufficient for classification

Self-heating substances and mixtures

Reason for no classification:

data conclusive but not sufficient for classification

Substances and mixtures which in contact with water emit flammable gases

Reason for no classification:

data conclusive but not sufficient for classification

Oxidising liquids

Reason for no classification:

data conclusive but not sufficient for classification

Oxidising solids

Reason for no classification:

data conclusive but not sufficient for classification

Organic peroxides

Reason for no classification:

data conclusive but not sufficient for classification

Corrosive to metals

Reason for no classification:

data conclusive but not sufficient for classification

Desensitized explosives

Reason for no classification:

data lacking

Health hazards

Acute toxicity - oral

Reason for no classification:

data conclusive but not sufficient for classification

Acute toxicity - dermal

Reason for no classification:

data conclusive but not sufficient for classification

Acute toxicity - inhalation

Reason for no classification:

data conclusive but not sufficient for classification

Skin corrosion / irritation

Reason for no classification:

data conclusive but not sufficient for classification

Serious eye damage / eye irritation

Reason for no classification:

data conclusive but not sufficient for classification

Respiratory sensitisation

Reason for no classification:

data conclusive but not sufficient for classification

Skin sensitisation

Reason for no classification:

data conclusive but not sufficient for classification

Aspiration hazard

Reason for no classification:

data lacking

Reproductive toxicity

Reason for no classification:

data lacking

Effects on or via lactation

Reason for no classification:

data lacking

Germ cell mutagenicity

Reason for no classification:

data conclusive but not sufficient for classification

Carcinogenicity

Reason for no classification:

data lacking

1. Specific target organ toxicity - single (STOT-SE)

Reason for no classification:

data conclusive but not sufficient for classification

1. Specific target organ toxicity - repeated (STOT-RE)

Reason for no classification:

data conclusive but not sufficient for classification

Environmental hazards

Hazardous to the aquatic environment (acute / short-term)

Reason for no classification:

data conclusive but not sufficient for classification

Hazardous to the aquatic environment (long-term)

Reason for no classification:

data conclusive but not sufficient for classification

Hazardous to the ozone layer

Reason for no classification:

data conclusive but not sufficient for classification

Labelling

Signal word:

No signal word