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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
N,N-1dimethyloctan-1-amine
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
N,N-1dimethyloctan-1-amine
PBT status:
the substance is not PBT / vPvB
Justification:

Biotic degradation-An OECD 301B ready biodegradability study is available for AD 1. Mean cumulative CO2production by mixtures containing AD 1 was equivalent to 15% of the theoretical value after three days and 67% after seven days; 98% degradation was achieved after 29 days.

Substances are considered to be readily biodegradable in this test if CO2production is equal to or greater than 60% of the theoretical value within 10 days of the level achieving 10%. AD 1 is therefore considered to be readily biodegradable.

The results of this study show that AD 1 does not fulfil the criteria for persistence and is NOT P and NOT vP.

Bioaccumulation Assessment

A substance fulfils the bioaccumulation criterion (B) when the bioconcentration factor in aquatic species is higher than 2000 or the log Kow is > 4.5. The octanol water partition coefficient for AD 1 is 2.17 (log KOW). A bioconcentration or bioaccumulation study in aquatic species is not available, however results estimated by QSAR in accordance with Section 1.3 of Annex XI may be used. The QSAR value for AD 1 using epiwin, BCFBAF v3.01, gives a worst case result of 318. Thus, the criteria for bioaccumulation is not fulfilled.

The results above shows no indication of a bioaccumulation potential in aquatic organisms (BCF <2000 and log Kow <4.5). Thus, neither the B nor the vB criterion is fulfilled.

Toxicity Assessment

The results from both the algal growth inhibition study and the OECD422 study indicate that AD 1 fulfills the criteria for ecotoxicity and toxic for reproduction 1B. On this basis, AD 1 fulfills the criteria as Toxic (T).

Emission Characterisation

Whilst AD 1 is not classified as PBT an emission characterization is required based on the tonnage (i.e. >10 t/a) and classification of AD 1 as Toxic for Reproduction 1B, H360, Aquatic chronic 1 H410.

Likely routes of exposure:

Likely routes of exposure will be assessed in the chemical safety assessment.