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PBT assessment

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PBT assessment: overall result

Reference
Name:
Butanone
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence Assessment

The substance is readily biodegradable. Hydrolysis is not expected under relevant environmental conditions (no experimental data). According to Regulation (EC) No 1907/2006 (REACH) ANNEX XIII and the Guidance on information requirements and chemical safety assessment, Chapter R.11 (PBT Assessment, May 2008), the substance does not fulfil the screening criterion “persistent (P)” and “very persistent (vP)” as within a 7 day window a degradation of 70% respectively 61% was observed in a closed bottle test according to OECD 301 D, indicative of ready biodegradability.

Bioaccumulation Assessment

According to Annex XIII of Regulation (EC) No 1907/2006 and to the Guidance on information requirements and chemical safety assessment Chapter R.11 (PBT Assessment, May 2008), a substance does not fulfil the criterion

“bioaccumulative (B)” or “very bioaccumulative (vB)” if the BCF is below 2000 respectively 5000 or the log Kow is below 4.5.

The log POW value for MEK was determined to be 0.3 and therefore well below the screening bioaccumulation criterion of 4.5. The BCF accordingly would also be well below 2000.

According to Guidance on information requirements and chemical safety assessment (May 2008), Chapter R.11, Figure 11-2: Integrated testing strategy for B-assessment, no further testing is required to conclude on the bioaccumulation criterion.

Toxicity Assessment

According to Annex XIII of Regulation (EC) No 1907/2006 and according to the Guidance on information requirements and chemical safety assessment Chapter 11 (PBT Assessment, May 2008), a substance does not fulfil the

criterion if the NOEC for marine or freshwater organisms is higher than 0.01mg/l and if there is no evidence of chronic toxicity considering human health and no classification as carcinogenic (category1 or 2), mutagenic (category 1or 2) or

toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/ECC.

As the substance is not toxic for human health and not classified as CMR, these criteria are not fulfilled. The substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic

for reproduction (category 1A, 1B or 2) and there is no evidence of chronic toxicity, as identified by the classifications STOT (repeated exposure), category 1(oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) or

category 2 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) according to Regulation (EC) No 1272/2008.

Furthermore, no data on long-term effect concentration for aquatic organisms is available but experimental studies on acute fish, algae and daphnia showed a toxicity of EC50 >>100mg/l which is clearly above the screening criteria for toxicity (< 0.1mg/l) according to Guidance on information requirements and chemical safety assessment (May 2008), Table R.11-4.

Therefore, it can be concluded that the substance does not fulfil the Toxicity criteria.

Likely routes of exposure:

As the substance does not fulfil any of the screening criteria for persistence, bioaccumulation or toxicity, it is not a PBT

or vPvB. No emission characterisation is required according to Guidance on information requirements and chemical

safety assessment (May 2008), chapter R.11.