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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

PBT AND VPVB ASSESSMENT

The assessment of PBT and vPvB is performed by comparison of the relevant intrinsic properties of TMQ with the criteria of the REACH regulation (Annex XIII) as shown inTable 39:

 

Table39.PBT and vPvB criteria and the corresponding properties ofTMQ

Criterion

PBT criteria

vPvB criteria

TMQ

Criterion
fulfilled?

P

Half-life in marine water > 60 d, or half-life in fresh- or estuarine water > 40 d, or half-life in marine sediment > 180 d, or half-life in fresh- or estuarine water sediment > 120 d, or half-life in soil > 120 d

Half-life in marine, fresh or esturarine water > 60 d, or half-life in marine, fresh or esturarine sediment > 180 d, or
half-life in soil > 180 d

Not readily biodegradable
(Bayer AG, 2000)

Not inherently biodegradable with adapted bacteria (Monsanto, 1979)

yes

B

BCF > 2000

BCF > 5000

 

Measured BCF of TMQ <2000 (MITI, 1995)

no

T

Long-term NOEC for marine or freshwater organisms < 0.01 mg/L

 

72h-EL0 (algae) ≥ 100mg/L
(Bayer AG, 2000)

48h-EL50 (daphnia) = 56mg/L (Bayer AG, 2000)

no

T

CMR

n.a.

Not classified as CMR

no

T

Other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC

n.a.

Not classified as T, R48, or Xn, R48 according to Directive 67/548/EEC

no

 Assessment of PBT/vPvB Properties - Comparison with the Criteria of Annex XIII

 

Persistence Assessment

TMQ is not readily biodegradable with no biodegradation observed in 28 days (Bayer AG, 2000) and not inherently biodegradable with only 1 % biodegradation observed in 35 days exposure to adapted bacteria (Monsanto, 1979); and hence TMQ is concluded as provisionally persistent under environmental conditions.

Bioaccumulation Assessment

The BCF of 108 - 1300 for TMQ was observed with Cyprinus carpio as test organism within 8 weeks (MITI, 1995). According to this result, TMQ can be considered as bioaccumulative; but does not fulfill B criterion.

Toxicity Assessment

The most sensitive acute toxicity of TMQ is to Daphnia with an EL50 of 56 mg/L based on water accommodated fraction (Bayer AG, 2000), which is much higher than 0.1 mg/L and hence presumably not toxic. The only chronic EL0 was determined in a 72h algal toxicity study as ≥ 100 mg/L (Bayer AG, 2000), which is also much higher than 0.01 mg/L and hence support the same conclusion that TMQ is not toxic.

Furthermore, the substance is not classified as carcinogenic, mutagenic or toxic for reproduction. For these reasons, the substance does not meet the T-criterion.

Summary and overall Conclusions on PBT or vPvB Properties

According to the information summarized above, only P criteriion is fulfilled but not Band T criteria; and hence TMQ is not PBT or vPvB substance.