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PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Summary and overall conclusions

Alchisor TAL 111 is decene, hydroformylation products, low boiling and can be characterised as a UVCB substance. As defined in the ‘Read-Across Justification Document’ section 13, data provided for the analogue substance Alchisor TAL 123 and the Alchisor TAL 111 consitutent category substances, Category 3 hydrocarbon solvents, are representative of Alchisor TAL 111 and suitable for assessment purposes. Alchisor TAL 111 does not fulfil the screening criteria for persistence, bioaccumulation, and toxicity. The overall conclusion is that Alchisor TAL 111, does not meet the PBT or vPvB criteria. No further testing is required.

Persistence Assessment (P)

Evidence of non-P / non-vP Properties

Results of the ready biodegradability tests withboth the analogue substance, Alchisor TAL 123, and the constituent categories, C9 -C14 aliphatics (2 -25% aromatics)demonstrate that Alchisor TAL 111 is readily degraded in fresh waters.

A reliable study (Cidaria and Capotorti, 1998) determined that Alchisor TAL 123 was 78.38% degraded by day 28 and narrowly missed the 10-day window threshold for >60% degredation. The test substance is a UVCB substance and is therefore not required to meet the 10-day pass criterion as described in Section 4.1.2.9.5. of Regulation No 286/2011 (which amends CLP) providing the legal basis for waving the 10-day window threshold for UVCBs. In conclusion,according to this study Alchisor TAL 123 and using read-across justifications presented in Section 13, Alchisor TAL 111 can be considered readily biodegradable.

Other Evidence ofnon-P / non-vP Properties

In addition, available information for the constituent categories of Alchisor TAL 111 support this finding. In a study commissioned by the CEFIC Hydrocarbon Solvents Producers Association (1995), Shellsol H (identified as a mixture of aliphatic and aromatic hydrocarbons) was assessed for ready biodegradability in a reliable (Klimisch 1), GLP compliant OECD Guideline 301 F study. In this test the hydrocarbon solvents biodegraded to an extent of 74.7% after 28 days with an unacclimated sewage sludge inoculum. The test substance was determined to be readily biodegradable.

Conclusion

In conclusion, both the analogue substance and consitutent category substances of Alchisor TAL 111 can be considered to be readily bioegradable based on reliable studies. Consequently in line with the detailed ECHA guidance Alchisor TAL 111 does not fulfil the criteria for Persistence (P).

Bioaccumulation Assessment (B)

Evidence of non-B / non-vB Properties

According to Annex XIII of Regulation (EC) No 1907/2006 and to the Guidance on information requirements and chemical safety assessment Chapter R.11 (PBT Assessment, ECHA (2008)), a substance does not fulfil the criteria “bioaccumulative (B)” or “very bioaccumulative (vB)” if the bioconcentration factor (BCF) is below 2000 or 5000 respectively or if the log Kow is below 4.5.

Standard tests for the bioaccumulation endpoint are intended for single substances. In the case of Alchisor TAL 111 and its analogue substance (Alchisor TAL 123) and category substances (C9-C14 aliphatics (2-25% aromatics)) the substance is a UVCB hydrocarbon and bioaccumulation testing is not appropriate for this complex substance. However, the bioaccumulation endpoint was predicted for representative hydrocarbon structures using the BCFWIN v2.16 model within EPISuite 3.12 or EUSES as input to the hydrocarbon block method incorporated into the PETRORISK model. The PETRORISK derivations are provided in Section 13 of the CSR. In addition, supporting information reported in CONCAWE’s approach (Lampi et al., 2010), which is also included in Section 13 of the CSR, provides evidence of over-estimation when BCF’s are predicted through modelling approaches. PETRORISK model predictions for hydrocarbons ranged from 45.5 to 21,710.

Other Evidence of non-B / non-vB Properties

Supporting information found in the CONCAWE report presents model predictions based on bioconcentration potential in fish and reliable experimental data for algae andDaphniaspecies. Two types of model prediction are presented; the first is a regression output from the BCFBAF model of EPISuite (US EPA, 2009) in which fish biotransformation of hydrocarbons is not explicitly taken into account. The second prediction uses the BCF model developed by Arnot and Gobas (2003) which includes lipid content predictions as recommended in ECHA Guidance (Chapter R.7C, ECHA, 2008). The report states that there is marked influence of fish biotransformation exerted on the predicted BCFs derived using the two types of modelled results for all hydrocarbon blocks (including, paraffins, iso-parafins (or branched paraffins) and mono-aromatics).

The BAF predictions were judged to be inappropriate for hydrocarbons since metabolism in the gut (which is effectively assumed in food chain model calculations) is ignored. The decision to exclude BAF model predictions was supported by the experimental dietary BMF data demonstrating the critical role of gut metabolism in limiting biomagnification of hydrocarbons via the diet. For example, for mono-aromatics C12 to C17, all regression model predictions are above the B (bioaccumulation (B) criterion in PBT assessment) criterion of 2000. When biotransformation is incorporated into the model, none of the predictions are above 2000. 

Experimentally-derived dietary BCF values which are typically more conservative than aqueous BCF values are below the B criterion for all tested structures (C9 to C16). Aqueous BCFs for all other mono-aromatic hydrocarbons are below 2000. 

Conclusion

It is concluded by CONCAWE that based on available data, mono-aromatic hydrocarbons are neither bioaccumulative nor very bioaccumulative. Similar assessments for paraffins and branched (or iso-) paraffins concluded that C13 and C14 paraffins and C12-C16 branched paraffins may be bioaccumulative but not very bioaccumulative. These paraffins are longer than those found in Alchisor TAL 111 and it is anticipated that shorter carbon chain lengths will have a lower potential to bioaccumulate. In addition, due to the ready biodegradability of Alchisor TAL 111 it is concluded that there is a low potential for exposure and bioaccumulation in terrestrial organisms.

Based on the evidence that Alchisor TAL 111 is readily biodegradable and predicted BCFs below the 2000 B-criterion the UVCB substance is not regarded as bioaccumulative in aquatic, sediment or terrestrial organisms. Alchisor TAL 111 does not fulfil the criteria “bioaccumulative (B)” or “very bioaccumulative (vB)”. According to ECHA Guidance on information requirements and chemical safety assessment (May 2008), Chapter R.11, Figure 11-2: Integrated testing strategy for B-assessment, no further testing is required to conclude on the bioaccumulation criterion.

Toxicity Assessment

Evidence of non-T Properties (Criteria Based on Annex VIII of REACH)

Although a toxicity assessment is not required if the P and B criteria are not met (see above) it is discussed here, for completeness. According to Annex XIII of Regulation (EC) No 1907/2006 and according to the Guidance on information requirements and chemical safety assessment Chapter 11 (PBT Assessment, May 2008), a substance does not fulfill the criterion if the NOEC for marine or freshwater organisms is 0.01 mg/l or higher and if there is no evidence of chronic toxicity considering human health and no classification as carcinogenic (category 1 or 2), mutagenic (category 1or 2) or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/ECC.

Study data for each analogue/constituent category has been evaluated and considered together. The most relevant and reliable NOELR study result from across the analogue/constituent categories has been identified and used to derive the PNEC. There are three trophic levels represented by long-term toxicity studies. The most sensitive NOELR is for fish (Redman, 2010) at 0.079 mg/L. In conclusion, Alchisor TAL 111 does not meet the T-criterion for classification.

Alchisor TAL 111 is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) and there is no evidence of chronic toxicity, as identified by the classifications STOT (repeated exposure), category 1 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) or category 2 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) according to Regulation (EC) No 1272/2008.

Other Evidence of non-T Properties

In the environmental compartment, reliable acute and chronic aquatic toxicity data for Alchisor TAL 111are available for fish, invertebrates, and algae species.Acute toxicity to fish and algae of Alchisor TAL 111 was >10 mg/L and for invertebrates it was >40 mg/L based on 50% mortality.Toxicity test results indicated fish are the most sensitive to Alchisor TAL 111 in acute, short-term exposures while invertebrates appear to be least sensitive.  The most sensitive short-term result for fish, invertebrates and algae is 10-30 mg/L (96-hr LL50for fish, expressed as a water accommodated fraction, WAF).

Data requirements for sediment and soil organisms are waived on the basis that direct and indirect exposure of these organisms to Alchisor TAL 111 is unlikely. In accordance with the technically robust approach defined in the 'Read-Across Justification' report in section 13, it is concluded that Alchisor TAL 111 is readily biodegradable in the environment. This is based on the reliable studies indicating that both the analogue substance, Alchisor TAL 123, and the constituent categories, C9 -C14 aliphatics (2 -25% aromatics), of Alchisor TAL 111 are both readily biodegradable. In the environment, ready biodegradability means that it is unlikely that aquatic, sediment or terrestrial life will be exposed to Alchisor TAL 111 over extended periods, with low potential to exert long-term toxic effects. In addition, ready biodegradability means it can be assumed that Alchisor TAL 111 and its constituents will be biodegraded within the STP processs and as a consequence a transfer to the sediment or soil compartment via STP effluent is not expected. Furthermore, for substances not passing the STP-process but being readily biodegradable, it can be assumed that they will be also biological degraded in the surface water within a short time.

Conclusion

Based on available reliable data for toxicity of Alchisor TAL 111, using read-across from the analogue substance/constituent category, short-term acute toxicity (LL50, LC50or EL50, EC50) to aquatic organisms is >0.01 mg/L and does not meet the definitive toxicity criterion according to the ECHA guidance on PBT assessment (Part C). Chronic data on aquatic species showed no effect concentrations (expressed as NOELR) >0.01 mg/l and therefore the criteria of Annex XIII REACH for aquatic toxicity are not fulfilled.Therefore, it can be concluded that the substance does not fulfill the toxicity (T) criterion as laid down in Annex XIII of regulation (EC) No 1907/2006.

PBT Assessment

Persistence: From a comparison of the results obtained forAlchisor TAL 111 with the criteria of REACH Annex XIII, it can be concluded that Alchisor TAL 111 is not persistent (P) under aerobic conditions.

Bioaccumulation: Alchisor TAL 111cannot be regarded as bioaccumulative in aquatic, sediment or terrestrial organisms. Reliable experimental studies indicate that the substance is readily biodegradable and modeled predictions demonstrate that when biotransformation is incorporated into the model, none of the BCF predictions are above 2000. In addition, experimentally-derived dietary BCF values which are typically more conservative than aqueous BCF values are below the B criterion for all tested structures (C9 to C16). Aqueous BCFs for all other mono-aromatic hydrocarbons are below 2000. Therefore, based on the criteria of REACH Annex XIII, it can be concluded that Alchisor TAL 111 is not bioaccumulative (B) or very bioaccumulative (vB).

Toxicity: Based on available reliable data for toxicity Alchisor TAL 111 short-term acute toxicity (LL50or EL50) to aquatic organisms is >0.01 mg/L and does not meet the definitive toxicity criterion according to the ECHA guidance on PBT assessment (Part C). Chronic data on aquatic species showed no effect concentrations (expressed as NOELR) >0.01 mg/l and therefore the criteria of Annex XIII REACH for aquatic toxicity are not fulfilled. Therefore, it can be concluded that the substance does not fulfill the Toxicity criteria as laid down in Annex XIII of regulation (EC) No 1907/2006.

The overall conclusion is thatAlchisor TAL 111does not meet the PBT or vPvB criteria. No further testing is required.