Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Short-term toxicity

Reliable short-term toxicity tests results are available for freshwater fish (Oncorhynchus mykiss), invertebrates (Daphnia magna) and algae (Scenedesmus subspicatus, new name: Desmodesmus subspicatus).

The relevant short-term key values are:

Fish: LC50 (96 h): >1 mg/l

Invertebrates: EC50 (48 h): 3.2 mg/l

Algae: EC50 (72h): >10 mg/l; EL10: 2.9 mg/L

Supporting data have been read-across from the mixture, Alcohols C14-C15 (CAS 75782-87-5) for fish and algae, with results all >LoS of the test substance.

Long-term toxicity

A reliable 21 day reproduction test has been carried out with Daphnia magna.

The relevant long-term value is:

Invertebrates: EC10 (21-day): 0.0063 mg/l

The study authors report the presence of fine particles or droplets in the key short- and long-term tests on invertebrates. There is also a possibility of physical fouling in the algae test. However, the presence of undissolved test material would not have affected the lower concentrations at which effects were seen during the long-term invertebrate test, and there were no effects at the limit of solubility in the short-term invertebrate and algae tests. Therefore the results of these tests can still be considered valid and appropriate to use for chemical safety assessment and PNEC derivation.

Toxicity to microorganisms

At or above the limit of water solubility, the registered substance has no significant inhibitory effects on respiration of activated sludges or specific microbial strains relevant to WWTP, based on consistent category evidence for C6-24 aliphatic alcohols. There is no hazard for WWTP microorganisms. Reliable data are available, for the species Pseudomonas putida. A 16-h toxicity threshold of 10000 mg/L was determined (read-across from structural analogues).

Sediment toxicity

A reliable 6 d EC50 value of 390 mg/kg dw soil (3.4% organic carbon) has been determined for the effects of the test substance on population numbers of the freshwater sediment dwelling ostracod H. incongruens. The study was conducted in a substrate composed of a mixture of soil and water and has therefore been regarded as a sediment test.

Discussion of trends in the Category of C6-24 linear and essentially-linear aliphatic alcohols:

Many short-term aquatic toxicity tests have been carried out on this family of long chain aliphatic (LCAAs), addressing toxicity to organisms from three trophic levels; fish, invertebrates and algae. For studies in which the test substance had a single carbon chain length, a key study has been identified for each taxonomic level. Where there were two or more reliable studies of the same quality but on different species within the same taxonomic group, the lower toxicity value (highest level of toxicity) was chosen. For studies in which the test substance was a multi-constituent LCAAs (commercial products) and where there was more than one type of the substance a key study was identified for each type.

The results of short-term tests performed on single carbon chain length LCAAs are generally reported in terms of the nominal or measured dissolved concentration of the alcohol in the test medium and are identified as EC50 or LC50 values. However there are also instances where the reported effect concentration exceeded the solubility of the LCAA. These instances are distinguished in the results tables either by the result being reported as an LL50 or EL50, implying that the test medium was a water accommodated fraction (WAF), or by a note indicating that the test substance loading exceeded the solubility of the LCAA. In the latter case it has had to be assumed (because it is not apparent from the test report) that undissolved LCAA may have been present in the test medium and that there was the potential for physical (rather than toxicity) effects to occur.

For studies using multi-constituent substances it is possible to interpret the results on the basis of measured dissolved concentrations of the LCAA constituents but they cannot be directly related to the concentration of the multi-constituent substance itself. This is because the test medium does not contain dissolved concentrations of the constituents in the same ratio as present in the substance itself. The toxicity data for mixed carbon chain length LCAAs are therefore also expressed using different conventions. Where the effect concentrations occurred at concentrations below the solubility limit of a multi-constituent substance they are reported as nominal or measured concentrations and are again identified as EC50 or LC50 values. In cases where the test media were WAFs, or where the loading of a multi-constituent substance exceeded the solubility of one or more of its constituents, the result is reported either as an LL50 or EL50, denoting that the test medium was a Water Accommodated Fraction (WAF), or by a note indicating that the test substance loading exceeded the solubility limit of the multi-constituent substance. Once again in the latter case it has had to be assumed (because it is not apparent from the test report) that undissolved LCAA may have been present in the test medium and that there was the potential for physical (rather than toxicity) effects to occur.

In Section 4 it was highlighted that biodegradation is likely to be a significant loss mechanism from aquatic media for the LCAAs under review. If loss of test substance from aquatic test media is significant it will undermine the results of tests where analysis of exposure was not performed. For example, exposure concentrations of octan-1-ol (No. 111-87-5) in a 7-day test with the fathead minnow (Pimephales promelas) declined by >90% in the unspecified period between media renewals (Pickering et al., 1996). However the NOEC has been expressed relative to nominal concentrations and must represent a significant overestimate of the true value and therefore an underestimate of the true toxicity. Similarly, the exposure concentration of the same substance that corresponded to the NOEC determined in a 21-day semi-static long-term test with Daphnia magna, declined by >35% over the 3-4 day period between media renewals (Kuhn et al., 1989). This suggests that exposure concentrations, expressed as nominal values, would have significantly overestimated the actual concentrations. The above examples highlight that test results expressed only in terms of nominal concentrations must be treated with considerable caution and may underestimate the toxicity of the substance.

Trends in results, described in this section, are supported by reliable measured data for branched LCAAs which are members of the Oxo Alcohols Category. For full details please refer to the Oxo alcohols SIAR and SIDS dossiers.

Where there were no available data for a linear LCAA the data has been read-across (see CSR section 1.4) from reliable data for the closest linear alcohols with a smaller carbon chain length.

For multi-constituent substances lacking measured short-term toxicity data, the data has been read-across from the major constituent linear LCAAs in cases where these formed >90% of the multi-constituent substance. This approach is deemed valid because it is considered very unlikely that the minor constituents present at <10% will contribute significantly to short-term effects. This approach has not been adopted for long-term toxicity data because here the potential for the minor constituents to contribute to effects is much greater.

In the absence of suitable read-across data for linear and multi-constituent LCAAs, validated QSAR methods have also been developed to fill data gaps for short-term toxicity to fish and invertebrates. QSARs for linear alcohols have also been developed to fill data gaps for long-term toxicity to invertebrates.

References:

Kuhn, R., Pattard, M., Pernak, K., and Winter, A. (1989). Results of the harmful effects of water pollutants to Daphnia magna in the 21 day reproduction test. Wat. Res. 23(4): 501-510.

Pickering, Q.H., Lazorchak, J.M., and Winks, K.L. (1996). Subchronic sensitivity of one-, four-, and seven-day-old fathead minnow (Pimephales promelas) larvae to five toxicants. Environ. Toxicol. Chem. 15(3): 353-359.