Registration Dossier

Classification & Labelling & PBT assessment

GHS

General Information

Name:
Reaction mass of 1-(C12-18-(even numbered))-alkyl-tetrahydropyrimidin-2(1H)-imine acetate salt and 1-(3-((C12-18-(even numbered))-alkyl-amino)propyl)guanidine acetate salt and 1-(C12-18-(even numbered))-alkyl-1-(3-guanidinopropyl)guanidine acetate salt
Implementation:
EU
Remarks:

Related composition: Reaction mass of 1-(C12-18-(even numbered)) -alkyl-tetrahydropyrimidin-2(1H) -imine acetate salt and 1-(3-(C12-18-(even numbered) -alkyl-amino) propyl) guanidine acetate salt and 1-(C12-18-(even numbered)) -alkyl-1-(3-guanidinopropyl) guanidine acetate salt

Remarks: STOT RE 2 revised and no longer applicable.

Justification: Based on ECHA guidance on the application of the CLP criteria (version 3.0), substances are classified as specific target organ toxicants following repeated exposure by the use of expert judgement on the basis of the weight of all evidence available, including the use of recommended guidance values. In this respect, the evidence from studies with repeated dose toxicity studies indicate that the submission substance has the potential to be harmful to human health following repeated exposure. Looking closely at the effects occurred after repeated exposure all findings indicate an unspecific effect resulting from the local irritation of the gastrointestinal tract including the esophagus. This finding is supported by the corrosive property of the test substance. Due to the corrosivity of the test substance a reduced food intake resulting in a reduce body weight gain and inflammatory changes in hematology is observed as secondary effect. Local effects in the stomach were also observed in the new performed OECD 414 study which further supports the mainly irritating property of the test substance. Taking into account all these information a classification with STOR-RE 2 is not applicable since the local irritation/corrosion effect is already covered by the Skin Corrosion 1C classification.

Related composition

Related composition:
Composition 3

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
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 lacking
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 lacking
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 lacking
Desensitized explosives
Reason for no classification:
data lacking
Acute toxicity - oral
Hazard category:
Acute Tox. 4
Hazard statement:
H302: Harmful if swallowed.
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
Hazard category:
Skin Corr. 1C
Hazard statement:
H314: Causes severe skin burns and eye damage.
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 conclusive but not sufficient for classification
1. Specific target organ toxicity - single
Reason for no classification:
data conclusive but not sufficient for classification
1. Specific target organ toxicity - repeated
Reason for no classification:
data conclusive but not sufficient for classification
Hazardous to the aquatic environment (acute / short-term)
Hazard category:
Aquatic Acute 1
Hazard statement:
H400: Very toxic to aquatic life.
Hazardous to the aquatic environment (long-term)
Hazard category:
Aquatic Chronic 1
Hazard statement:
H410: Very toxic to aquatic life with long lasting effects.
M-Factor acute:
10
M-Factor chronic:
1
Hazardous to the ozone layer
Reason for no classification:
data lacking

Labelling

Signal word:
Danger

Hazard pictogram

GHS05: corrosion
GHS07: exclamation mark
GHS09: environment

Hazard statements

H302: Harmful if swallowed.
H314: Causes severe skin burns and eye damage.
H410: Very toxic to aquatic life with long lasting effects.

Precautionary statements

P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P280: Wear protective gloves/protective clothing/eye protection/face protection/hearing protection/...
P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER/doctor/…
P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ...
supplier

Notes