Resin acids and Rosin acids, calcium salts

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

8.1.1.1.1. Persistence assessment

Screening criteria

- Not P / vP based on ready biodegradability:One of the screening criteria for persistence is that if a substance is considered to be readily biodegradable the substance is screened as being not P and not vP. Members of this category have been shown to be readily biodegradable in biodegradation screening tests (Harlan 2010a, Harlan 2010b, Harlan 2010c, Akzo Nobel 1999a, Akzo Nobel 1999b). Further studies determined members of this category to be readily biodegradable, but failing the 10-day window (Harlan 2010d, Wildlife International 1998).Therefore, based on the screening criteria for persistence stipulated in the ECHA’s Guidance on information requirements and chemical safety assessment - Part C: PBT Assessment (2008) members of this category do not meet the criteria to be considered persistent (P) or very persistent (vP).

Conclusion on P / vP properties:not P/vP

8.1.1.1.2. Bioaccumulation assessment

Criteria based on Annex XIII of REACH

- Not B / vB based on BCF <= 2000 L/kg:(The screening criterion for bioaccumulation is that a substance is not B or vB if it has a log Kow of ≤4.5. Experimental data on Kow are available for members of this category. The measured log Kow of 0.74 - >6 indicates that the members of this category exceed the screening criteria for bioaccumulation stipulated in the ECHA’s Guidance on information requirements and chemical safety assessment - Part C: PBT Assessment (2008) and could be considered bioaccumulative.

Measured BCFs for various resin acids that are the predominant components of members of this category, are available and report BCF of <25-130 (Niimi and Lee 1992). In addition, calculated BCF values for category members based on the measured log Kow indicate BCF in the range 3.162 – 56.23 L/kg ww. This would indicate that substances in this category are not bioaccumulative.

Based on the measured BCF for various resin acids, members of this category are not considered to be bioaccumulative (B) or very bioaccumulative (vB).)

Conclusion on B / vB properties:not B/vB

8.1.1.1.3. Toxicity assessment

Criteria based on Annex XIII of REACH

- Not T based on criteria laid down in Annex XIII of REACH:

·   EC10 / NOEC >= 0.01 mg/L for marine / freshwater organisms (long-term toxicity):

Reliable studies are available for Daphnia, fish and algae for various members of this category. The lowest acute LC50 is 1.6 mg/L for Daphnia (Eastman 2005).

On the basis of this data, the screening criteria for toxicity stipulated in the ECHA’s Guidance on information requirements and chemical safety assessment - Part C: PBT Assessment (2008) are not met, and the definitive toxicity criteria stipulated in Annex XIII are thought unlikely to be met. Therefore, members of this category are not considered to be T.

·   Substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC (or the DSD) or carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008 (or CLP Regulation) (see also section "3. Classification and labelling"):

Carcinogenicity. Members of this category are not classifiable with regard to human carcinogenicity based on a lack of experimental animal data. However these substances are not mutagenic or carcinogenic, and show no evidence of cumulative toxicity or hyperplasia in repeated dose toxicity studies. No relevant human studies, or reports of adverse effects in exposed human populations, were identified. Overall, there are no data to suggest that they are potentially carcinogenic to humans.

Mutagenicity. Members of this category are not mutagenic based on results of in vitro testing and an absence of structural chemical alerts. Overall, there are no data to suggest that they are potentially mutagenic to humans.

Reproductive Toxicity. No developmental or 2-generation reproductive toxicity data are available for the members of this category, however results from screening tests indicate no effect on reproductive or developmental parameters. Data from repeated dose toxicity testing indicate low toxicological activity, including an absence of effects on reproductive tissues. No relevant human studies, or reports of adverse effects in exposed human populations, were identified. Collectively, this information suggests that these substances are unlikely to be reproductive toxins.

·   Substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC (or the DSD) or carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008 (or CLP Regulation) (see also section "3. Classification and labelling"):

·   No other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008:

Members of this category are not classified as T, R48, or Xn, R48 according to Directive 67/548/EEC, nor do they attract a comparable level of classification under Regulation 1272/2008.

Conclusion on T properties:not T