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Classification & Labelling & PBT assessment

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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 As such, these revised values indicate that classification as R52-53 is no longer applicable.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

Classificationopen allclose all

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
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
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

Notes