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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:

Persistence:

Neo Heliopan® AP is not readily biodegradable under the conditions of the ready biodegradability tests performed. However, Neo Heliopan® AP was identified non-toxic in these tests. Respective QSAR calculations confirm that the substance is not ready biodegradable.

An atmospheric degradation by reaction with OH-radicals can safely be assumed given a calculated half-life of ~19 hours. As the substance has a half-life in air < 2 days, it is not expected to stay in the atmosphere for long and there is a limited potential for long range atmospheric transport.

In a weight-of-evidence approach, considering a combination of test results and QSAR predictions of NeoHeliopan® AP, a certain persistency potential cannot be excluded.

Bioaccumulation:

According to ECHA “Guidance on information requirements and chemical safety assessment / Part C: PBT assessment” (December 2011), the criteria for bioaccumulation (B and vB) are not fulfilled, if the logPow is ≤ 4.5.

For organic substances with a log Kow value below 4.5 it is assumed that the affinity for the lipids of an organism is insufficient to exceed the B criterion, i.e. a BCF value of 2000 L/kg ww.

Furthermore, there is no convincing evidence that Neo Heliopan® AP can biomagnify in the food chain (BMF < 1). Therefore, the criteria for “bioaccumulating” and for “very bioaccumulating” are not fulfilled. The substance Neo Heliopan® AP does not qualify as a “B” or “vB” substance.

Toxicity:

The T criteria to clarify if a substance is toxic are not fulfilled for the substance Neo Heliopan® AP for the following reasons:

 

1. Regarding aquatic toxicity:According to ECHA guidance, a substance is considered to potentially meet the T criteria when an acute L/EC50value from a standard E/LC50toxicity test is less than 0.1 mg/L.

Acute toxicity data are available for fish, daphnia and algae. None of the E/LC50values are < 0.1 mg/L.

 

According to the REACH legislation (Annex XIII), a substance fulfils the toxicity criterion (T) regarding aquatic toxicity when the long-term NOEC for marine or freshwater organisms is less than 0.01 mg/L.

Chronic data available for algae and daphnia indicate that NOEC and 72-h ErC10 values are far above 0.01 mg/L (Algae NOEC (72 h) ≥ 88.2 mg/L; Daphnia EC10>1 mg/L).

 

Regarding aquatic toxicity, the Toxicity criteria are not fulfilled for the substance NeoHeliopan® AP.

 

2. Regarding carcinogenicity, mutagenicity, or reproductive toxicity, a substance is considered to potentially meet the T criteria if it classifies for carcinogenicity (cat 1/2), mutagenicity (cat 1/2), or reproductive toxicity (cat 1/2/3). None of the relevant tests conducted with NeoHeliopan® AP, including a 13-w oral toxicity study in rats (OECD 408), prenatal developmental toxicity study (OECD 414) and relevant in vitro mutagenicity tests (OECD 471, 473 and 476) indicate a potential for carcinogenicity, mutagenicity, or reproductive toxicity. Regarding carcinogenicity (cat 1/2), mutagenicity (cat 1/2), or reproductive toxicity (cat 1/2/3), the Toxicity criteria are not fulfilled for the substance NeoHeliopan® AP.

 

3. Regarding other evidence of chronic toxicity, a substance is considered to potentially meet the T criteria if it classifies T, R48, or Xn, R48 according to Directive 67/548/EEC. None of the relevant tests conducted with NeoHeliopan® AP, including a 13-w oral toxicity study in rats (OECD 408), prenatal developmental toxicity study (OECD 414) and relevant in vitro mutagenicity tests (OECD 471, 473 and 476) indicate a potential for chronic toxicity according to Directive 67/548/EEC. Regarding chronic toxicity, the Toxicity criteria are not fulfilled for the substance NeoHeliopan® AP.

 

Thus, Neo Heliopan® AP does not qualify as a “T” substance.