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PBT assessment

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PBT assessment: overall result

Reaction mass of (octan‐2‐yl)benzene and (octan‐3‐yl)benzene and (octan‐4‐yl)benzene
Type of composition:
boundary composition of the substance
State / form:
Reference substance:
Reaction mass of (octan‐2‐yl)benzene and (octan‐3‐yl)benzene and (octan‐4‐yl)benzene
Reference substance:
Reaction mass of (octan‐2‐yl)benzene and (octan‐3‐yl)benzene and (octan‐4‐yl)benzene
Reference substance:
Reaction mass of (octan‐2‐yl)benzene and (octan‐3‐yl)benzene and (octan‐4‐yl)benzene
PBT status:
the substance is handled as if it were a PBT/vPvB

Screening vP and P:

Based on the fact that the substance was not ready biodegradable under the stringent conditions of a ready biodegradability test, it fulfills the screening criterion for vP and P. However, the Annex XIII criterion is inconclusive due to the lack of data.

Screening vB and B:

The log Kow is >4.5  (Log Kow = 7.0-7.2) and therefore it can not be concluded that the substance is not B/vB.

Screening T:

Human health toxicity:

The substance is not classified as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008.

The substance does not meet the criteria for classification as acute toxic or STOT SE by the oral route, according to Regulation EC No 1272/2008. Furthermore no systemic effects have been observed in in vivo studies with dermal exposure (skin sensitization).

Environmental toxicity:

For the three trophic levels (fish, invertebrates and algae), the short term toxicity has been determined. As no effects were observed at the maximum solubility of the substance in test medium, the T criterion is not considered fulfilled based on the available information. For a definitive classsification as not T, a long term aquatic NOEC or EC10 ≥ 0.01 mg/L to fish and/or daphnia would be necessary. However, as the substance will be treated as if it is PBT or vPvB no further testing will be necessary.

PBT status:

It is therefore concluded that the available information does not allow to conclude whether or not the substance is PBT/vPvB. According to REACH Annex XIII section 2.1, the registrant decides not to generate further information, as he fulfils the conditions of exposure based adaptation of Annex XI, Section 3.2(b) and (c). The registrant considers therefore the substance as if it is a PBT or vPvB substance. See the attached document for details on the argumentation.

The substance as a whole was considered for PBT assessment despite some slight differences in the properties of the constituents. It can be reasonably assumed (e.g. based on the known chemical composition) that the constituents are structurally similar and therefore can be expected to have reasonably similar PBT-properties.

Likely routes of exposure:

Under normal and standard conditions of use, there are no exposure routes by which humans and the environment are exposed to the substance. The substance is not released to environmental compartments during all activities carried out by the registrant and during all identified uses. See the attached document and the CSR for details.