Registration Dossier

Administrative data

Endpoint:
bioaccumulation: aquatic / sediment
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Data source

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Applicant's summary and conclusion

Conclusions:
Considering REACH Annex IX 9.3.2 criteria, bioaccumulation in aquatic species, preferably fish, may be proposed. However, as the substance is poorly soluble in water, exposure of the aquatic compartment is unlikely: this test is not proposed to be performed.
Executive summary:

No experimental data on aquatic bioaccumulation are available for the substance.

The study for determine the partition coefficient (log KOW) give a data range from 4.3 to 9.7 indicating high bioaccumulation potential.

The substance contains about 50 – 60 % of 1-eicosanol (log KOW= 8.7) and 1-docosanol (log KOW = 9.7). The alkyl chain length has the most impact on the log KOW value.

A quantitative estimation of the bioconcentration factor (BCF) for fish can be performed according to the parabolic equation given in the Guidance on information requirements and chemical safety assessment (Chapter R.7c) for substances having a log Pow > 6 (with log KOW = 9.7) :

Parabolic equation:

log BCFfish = -0.20 x (log KOW)² + 2.74 x log KOW – 4.72

log BCFfish  = -0.20 x (9.7)² + 2.74 x 9.7 – 4.72

log BCFfish  = 3.04

BCFfish = 1096 L/kg

A BCF of 3.162 L/kg was estimated by BCFWIN using log KOW of 9.7. However, this method delivers many underestimations of BCFs. Hence, this QSAR-method is not reliable for estimating the bioaccumulation potential of the substance.

BCFWIN and equation lead to very different results.

Considering REACH Annex IX 9.3.2criteria, bioaccumulation in aquatic species, preferably fish, may be proposed. However, as the substance is poorly soluble in water, exposure of the aquatic compartment is unlikely: this test is not proposed to be performed.