Coffee, bean, roasted, ext.

PBT assessment

PBT assessment: overall result

Reference

Name:

Coffee, bean, roasted, ext. legal entity composition

Type of composition:

legal entity composition of the substance

State / form:

liquid

Reference substance:

Coffee, bean, roasted, ext. legal entity composition

Reference substance:

Coffee, bean, roasted, ext. legal entity composition

Reference substance:

Coffee, bean, roasted, ext. legal entity composition

Reference substance:

Coffee, bean, roasted, ext. legal entity composition

Reference substance:

Coffee, bean, roasted, ext. legal entity composition

Reference substance:

Coffee, bean, roasted, ext. legal entity composition

Reference substance:

Coffee, bean, roasted, ext. legal entity composition

Reference substance:

Coffee, bean, roasted, ext. legal entity composition

Reference substance:

Coffee, bean, roasted, ext. legal entity composition

PBT status:

the substance is not PBT / vPvB

Justification:

Persistence Assessment:

Coffee extract cannot be classified as readily biodegradable under the conditions of this test since it did not achieve =60% biodegradation within 28 days. Since the coffee extract degraded by approximately 50% and this is considered significant degradation, it is likely that coffee extract would not be very persistent in the environment. The test validity criteria were all reported to be met.

An activated sludge respiration inhibition test (ASRIT) was conducted on the substance in which the test validity criteria were also reported to have been met. The test indicated that the EC50 based on the measured lowest concentration was 5164 mg/L. This indicates that the substance is not toxic to microorganisms at the sewage treatment plant and does not inhibit the performance of the plant to carry out its biodegradation processes.

Given the inherent biodegradation of the substance as indicated by the 50% degradation observed in the OECD 301D study and the lack of toxicity in the ASRIT test the substance is considered to be potentially not P and not vP.

Bioaccumulation Assessment:

Solubility and partition coefficient studies were conducted for the substance. The water solubility study was conducted in accordance with EU guideline A6(EC) and the octanol-water partitioning coefficient study was conducted in accordance with EU guideline A8(EC). Results of the water solubility test indicate that the substance solubility in water is 2.85%, which is indicative of low solubility. The octanol-water partitioning coefficient indicates that the Log Pow (Kow) of the substance is <0.36 which is indicative of very low accumulation potential.

The low Kow of the substance indicates that the substance has low bioaccumulative potential. The screening criterion of having a Kow >4.5 for bioaccumulation is not met and therefore the substance is not B.

Toxicity Assessment:

A toxicity assessment is not strictly required as the substance does not meet the B criteria and also potentially does not meet the P criteria. However, for completeness the following toxicity assessment was conducted.

The substance does not meet the human health classification criteria of carcinogenic (cat. 1A or 1B), germ cell mutagenic (cat. 1A or 1B), or toxic to reproduction (cat. 1A, 1B or 2) or STOT RE 1, or STOT RE 2 or any EC50 or LC50 = 0.01 mg/L and therefore it is not considered to be T.

The environmental toxicity studies were conducted using the Water Accommodated Fraction (WAF) approach because the whole substance was being tested. The algal growth inhibition test indicated that the nominal WAF concentration of 100 mg/L resulted in an EL50 of >100 mg/L. The algal yield EL50 was 76 mg/L. The Daphnia immobilisation study also resulted in an EL50 of >100 mg/L. Both studies indicate that the substance is not toxic to environmental receptors.

Similarly, the toxic effect of the test item to Rainbow Trout (Oncorhynchus mykiss) was assessed in a static concentration-response test. Based on the test results the 96-hour LC50 was determined to be >100 mg/L loading rate WAF based on nominal concentrations.

According to the R.11 Guidance if the substance is considered to be P then a chronic evaluation of toxicity is warranted. However, given that the substance was not toxic to activated sludge in the ASRIT study and is inherently biodegradable as indicated in the OECD study then it reasonable to assume that the substance will not be persistent or toxic enough to be of concern. Therefore, based on the classification of the substance for human health and the results of the ecotoxicological studies the test item Coffee, bean, roasted is not T.