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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
Reaction product of (C8 – C18) aliphatic primary amines (partly unsaturated) and p-phenetidine with a mixture of aromatic isocyanates comprising of primarily 4,4’-methylenediphenyl diisocyanate and 4-methyl-m-phenylene diisocyanate
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
Reaction product of (C8 – C18) aliphatic primary amines (partly unsaturated) and p-phenetidine with a mixture of aromatic isocyanates comprising of primarily 4,4’-methylenediphenyl diisocyanate and 4-methyl-m-phenylene diisocyanate
Reference substance:
Reaction product of (C8 – C18) aliphatic primary amines (partly unsaturated) and p-phenetidine with a mixture of aromatic isocyanates comprising of primarily 4,4’-methylenediphenyl diisocyanate and 4-methyl-m-phenylene diisocyanate
Reference substance:
Reaction product of (C8 – C18) aliphatic primary amines (partly unsaturated) and p-phenetidine with a mixture of aromatic isocyanates comprising of primarily 4,4’-methylenediphenyl diisocyanate and 4-methyl-m-phenylene diisocyanate
Reference substance:
Reaction product of (C8 – C18) aliphatic primary amines (partly unsaturated) and p-phenetidine with a mixture of aromatic isocyanates comprising of primarily 4,4’-methylenediphenyl diisocyanate and 4-methyl-m-phenylene diisocyanate
Reference substance:
Reaction product of (C8 – C18) aliphatic primary amines (partly unsaturated) and p-phenetidine with a mixture of aromatic isocyanates comprising of primarily 4,4’-methylenediphenyl diisocyanate and 4-methyl-m-phenylene diisocyanate
Reference substance:
Reaction product of (C8 – C18) aliphatic primary amines (partly unsaturated) and p-phenetidine with a mixture of aromatic isocyanates comprising of primarily 4,4’-methylenediphenyl diisocyanate and 4-methyl-m-phenylene diisocyanate
PBT status:
the substance is not PBT / vPvB
Justification:

Conclusion on Persistance: not vP and not P

In a Manometric Respirometry Test over a period of 28 days according to EU method C.4-D, OECD guideline 301 F and OPPTS-method 835.3110, the submission substance was found to be not readily biodegradable. Therefore, the submission substance is considered to be potentially P/vP.

Conclusion on Bioaccumulation: not vB and not B

The log Pow-value of the substance was found to be >5 (see IUCLID section 4.7). However, a bioaccumulation study with the read across substance Tolyl bis urea compound demonstrated that the test item has no bioaccumulation potential (see IUCLID section 5.3.1). Consequently, the submission substance is considered to be non-bioaccumulative (not B/vB).

Conclusion on Toxicity: not T

EC10 or NOEC values from standard chronic / long-term toxicity tests on algae, daphia and fish are not available. Considering the available acute EC50 data that are all > 100 mg/L (LC50 (fish, 96h): > 100 mg/L; EC50 (daphnia, 48h): > 100 mg/L; EC50 (algae, 72h): > 100 mg/L), which are much higher than the threshold value for T properties of 0.1 mg/L as given in the ECHA Guidance on Information Requirements and Chemical Safety Assessment, chapter R.11: PBT/vPvB assessment (Version 3, June 2017), T properties can be ruled out for the aquatic compartment. Moreover, the substance is not classified as carcinogenic, mutagenic or toxic for reproduction according to Directive 67/548, or carcinogenic, germ cell mutagenic or toxic for reproduction according to Regulation EC No 1272/2008; and there is no evidence of chronic toxicity according to Directive 67/548/EEC, or specific target organ toxicity after repeated exposure according to Regulation 1272/2008. Thus, the substance is not T.

Overall conclusion on PBT and vPvB

Based on the available information, the substance is not PBT / vPvB according to Regulation (EC) 1907/2006.