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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:

According to definitions outlined in REACH Annex XIII and the further specifications in the Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment (May 2008), section R.11.1.2.1 Definitive criteria, pages 12 and 13, B-TEGME is not a PBT or vPvB substance.

The criteria for the PBT and vPvB assessment are outlined inREACH Annex XIII chapter 1.1 to 1.3 and 2.1 and 2.2 (pages 383 to 385) and further specifications in the Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment (May 2008).

The assessment of the PBT properties will be performed separately forPersistence,Bioaccumulation andToxicity. The assessment of the vPvB properties will be performed after assessment of the PBT assessment.

 

Persistence:

 

In REACH Annex XIII chapter 1.1 (page 383) it is outlined that "a substance fulfils the persistence criterion (P-) when:

  • the half-life in marine water is higher than 60 days, or
  • the half-life in fresh- or estuarine water is higher than 40 days, or
  • the half-life in marine sediment is higher than 180 days, or
  • the half-life in fresh- or estuarine water sediment is higher than 120 days, or
  • the half-life in soil is higher than 120 days."

 

B-TEGME hydrolyses spontaneously when it comes in contact with water. Furthermore, B-TEGME is ready biodegradable.

 

Based on these characteristics, it is considered that B-TEGME does not fulfill the criteria for persistence.

 

Bioaccumulation:

 

In REACH Annex XIII chapter 1.2 (page 384) it is outlined that "a substance fulfils the bioaccumulation criterion (B-) when:

  • the bioconcentration factor (BCF) is higher than 2000.

The assessment of bioaccumulation shall be based on measured data on bioconcentration in aquatic species. Data from freshwater as well as marine water species can be used."

 

The bioaccumulation potential of B-TEGME was calculated using an established QSAR tool (EPIWIN 40) resulting in a log Pow of -4.37. This calculation was supported by measurement of a brake fluid, indicating that none of the major components - of which B-TEGME is one - had a log Pow of > 0.5. For the risk assessment an unrealistically high and hence worst case log Pow of 1 was used. REACH Annex IX section 9.3.2 specified that an experimental "study need not be conducted if the substance has an low potential for bioaccumulation (for instance a log Kow < 3) ..." Hence, even if the unrealistic high log Pow of 1 is used, it is considerably below the trigger value of log Kow of 3 for triggering an experimental study. It can be concluded that B-TEGME has a low potential for bioaccumulation.

 

Based on these characteristics, it is considered that B-TEGME does not fulfill the criteria for bioaccumulation.

 

Toxicity:

In REACH Annex XIII chapter 1.3 (page 384) it is outlined that "a substance fulfils the toxicity criterion (T-) when:

  • the long-term no-observed effect concentration (NOEC) for marine or freshwater organisms is less than 0,01 mg/l, or
  • the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1or 2), or toxic for reproduction (category 1, 2, or 3), or
  • there is other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC."

 

These items will be addressed below.

 

Long-term no-observed effect concentration (NOEC) for marine or freshwater organisms of less than 0,01 mg/l:

 

In general, the evaluation for toxicity should be based on long-term studies.

 

For B-TEGME acute studies for fish and daphnids (EC50) and a NOEC for algae are available.

 

TheGuidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (May 2008) Section R.11.1.3.3 (page 35) states that "a substance is considered to potentially meet the criteria for T when an acute E(L)C50 value from a standard E(L)C50 toxicity test (REACH Annexes VII to X) is less than 0.1 mg/l."

 

Based on this, B-TEGME is considered as substance with a low potential for meeting the toxicity criteria since the EC50 for daphnids and fish and the NOEC for algae were > 100 mg B-TEGME/L.

 

Further arguments for considering B-TEGME as substance not fulfilling the toxicity criterion comes from the criteria for "no hazard" which are specified in the draft guidance for Chapter B8 (Guidance on information requirements and chemical safety assessment, Part B: Hazard Assessment, Draft new chapter B.8 Scope of Exposure Assessment, draft version 23 February 2010, page 12).

"Absence of significant ecotoxicological effects (and thus "no hazard") may be concluded if all of the following criteria are met:

  • The intrinsic properties of the substance are well below the criteria for classification as dangerous (hazardous) in accordance with Directive 67/548/EEC (or Regulation (EC) No 1272/2008), using all available data. i. e.:

·        the substance has a very low potential to bioaccumulate in aquatic species (e. g. fish) i. e. experimentally determined BCF < 10. For organic substances an alternative criterion, log Kow < 2.0 can be applied

·        the substance is readily biodegradable (this criterion does not apply to inorganic substances)

·        the aquatic toxicity has to fulfil both of the following criteria:

·        acute, short-term E(L) C50 > 1000 mg/l or> water solubility, or no significant adverse effects recorded at 100 mg/l in acute, short-term aquatic toxicity tests and validated QSAR data showing acute effects (E(L) C50) > 1000 mg/l

·        chronic long-term NOEC (or equivalent ECx; e. g. EC10) > 10 mg/L

  • The substance shall not have adverse effects on terrestrial organisms, meaning that no adverse effects are reported in any of the tests required under Annex IX of REACH at the maximum test concentrations prescribed by the respective OECD guidelines.

It might be the case that no studies on terrestrial organisms are available based on considerations that direct and indirect exposure of the soil compartment is unlikely. If a registrant has adapted the standard information requirements, this has to be well documented and justified in the registration dossier. Thus, the justification given for waiving the tests should either refer either to exposure considerations or it should be based on relevant substance properties, such as partitioning behaviour.

  • The substance shall not be identified as having or be suspected to have endocrine activity from in vivo or in vitro tests, nor from the application of relevant (Q)SAR models or other structural alerts which may give rise any concern for endocrine-disrupting properties (DG Environment, ENV. D4. /ETU/2005/0028r; http: /ec. europa. eu/ environment/endocrine/documents/final_report_2007. pdf). "

These requirements are addressed for B-TEGME as follows:

  • Intrinsic properties:

·        B-TEGME has a log Kow of -4.37 and hence a very low risk for bioaccumulation

·        B-TEGME is readily biodegradable

·        The EC50 values obtained in the acute, short term aquatic tests were > 100 mg B-TEGME/L

·        QSAR calculations with ECOSAR (v1.00) as implemented in EPIwin 4.0 support the tests as they indicate that the EC50 values for fish daphnids and algae are >>1000 mg B-TEGME/L (see page 3 of the printout attached to this waiver)

·        The long-term NOEC from algae is >> 10 mg B-TEGME/L

  • B-TEGME is not expected to have adverse effects on terrestrial organisms
  • B-TEGME is not identified as having or be suspected to have endocrine activity from in vivo or in vitro tests

These arguments support that there is no ecotoxicological hazard arising from B-TEGME and that the hazard is already appropriately described with the available studies and hence not long-term testing is needed to evaluate the toxicity criterion of the PBT assessment.

 

Classification as carcinogenic (category 1 or 2), mutagenic (category 1or 2), or toxic for reproduction (category 1, 2, or 3)

B-TEGME is classified as toxic for reproduction, category 2. Accordingly, the T criterion is met..

 

Classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.

B-TEGME is not classified as T, R48, or Xn, R48 according to Directive 67/548/EEC.

Based on these characteristics, it is considered that B-TEGME does fulfill the criteria for toxicity.

According to definitions outlined in REACH Annex XIII and the further specifications in the Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment (May 2008), B-TEGME is not a PBT substance.

 

According to definitions outlined in REACH Annex XIII section 2 (page 385) a vPvB – substance is a

substance that fulfils the criteria of the sections below

2.1 Persistence

A substance fulfils the very persistence criterion (vP-) when:

·           the half-life in marine, fresh- or estuarine water is higher than 60 days, or

·           the half-life in marine, fresh- or estuarine water sediment is higher than 180 days, or

·           the half-life in soil is higher than 180.

2.2 Bioaccumulation

A substance fulfils the very bioaccumulative criterion (vB-) when:

·           – the bioconcentration factor is greater than 5 000.

Following the argumentation for the PBT assessment B-TEGME is not a vPvB substance since not even the P and B criteria were met.