Registration Dossier

Classification & Labelling & PBT assessment

DSD-DPD

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
Status:
67/548/EEC self classification
Remarks:
R48/22 revised and no longer applicable.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

Classification

Explosiveness

Reason for no classification:
data conclusive but not sufficient for classification

Oxidising properties

Reason for no classification:
data conclusive but not sufficient for classification

Flammability

Reason for no classification:
data conclusive but not sufficient for classification

Thermal stability

Reason for no classification:
data lacking

Acute toxicity

Classification:
Xn; R22 Harmful if swallowed.

Acute toxicity - irreversible damage after single exposure

Reason for no classification:
data lacking

Repeated dose toxicity

Reason for no classification:
data conclusive but not sufficient for classification

Irritation / corrosion

Classification:
C; R34 Causes burns.

Sensitisation

Reason for no classification:
data conclusive but not sufficient for classification

Carcinogenicity

Reason for no classification:
data conclusive but not sufficient for classification

Mutagenicity - genetic toxicity

Reason for no classification:
data conclusive but not sufficient for classification

Toxicity to reproduction - fertility

Reason for no classification:
data lacking

Toxicity to reproduction - development

Reason for no classification:
data lacking

Toxicity to reproduction - breastfed babies

Reason for no classification:
data lacking

Environment

Classification:
N; R50/53 Dangerous for the environment; Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

Labelling

Indication of danger

C - corrosive
N - dangerous for the environment

Risk phrases

R22 - Harmful if swallowed
R34 - Causes burns
R50/53 - Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment

Specific concentration limits

Notes