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PBT assessment

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PBT assessment: overall result

Reference
Name:
Phenol, styrenated
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
Phenol, styrenated
Reference substance:
Phenol, styrenated
Reference substance:
Phenol, styrenated
Reference substance:
Phenol, styrenated
Reference substance:
Phenol, styrenated
PBT status:
the substance is not PBT / vPvB
Justification:

Classification oftest chemical for effects in the environment:

The test chemical is used as an additive for natural rubber, synthetic rubber, adhesives, plastics, textile fibres, cable coatings, flooring, polyurethane foam, coated paper, and natural synthetic oils etc. It is also used as an antioxidant and intermediate. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled fortest chemical. The PBT criterion was herein assessed based on experimental data in conjunction with standardized environmental fate models. Here follows a description of the PBT assessment.

 

Persistence assessment

The tested substance does not fulfils the P criterion within Annex XIII based on the assessment that here follows:

 

Environmental fate

In the study the rate and route of transformation of [14C]tristyrenated phenol was studied in four European soils, a sandy loam (18 Acres, from the United Kingdom), a silt loam (Gartenacker, from Switzerland), a silt loam (Krone, from the United Kingdom), and a loam (Vetroz, from Switzerland). The study was performed according to OECD TG 307 and in compliance to GLP. Test systems consisted of 100 g soil (dry weight equivalent) aliquots, which were adjusted to a moisture level of approximately pF 2.5, connected to volatile traps, and incubated under aerobic conditions in the dark at 12 ± 2 °C and 20 ± 2 °C. [14C]Tristyrenated phenol was applied at a nominal concentration of 0.6 μg/g. Soil samples were extracted according to the extraction method and analyzed by LSC and HPLC-RAM for determination and profiling of extractable residues. The post-extraction soils were combusted and analyzed by LSC for determination of non-extractable residues. The volatile traps were analyzed by LSC for determination of 14CO2 and volatile organics. Average material balance ranged from 94.7 to 103.1% AR and 95.9 to 107.2% AR over the course of the study for the 12 ± 2 °C and 20 ± 2 °C test systems, respectively. All validity criteria were fulfilled, all amendments do not affect the final results, and in the end, the study results are considered valid. [14C]Tristyrenated phenol transformed rapidly over the incubation period under the conditions of this aerobic soil study, with DT50 ranging from 3.13 to 12.5 days at 12 °C and 2.88 to 8.46 days at 20 °C. The rapid degradation of [14C]Tristyrenated phenol combined with a significant amount (≤ 22% AR) of 14CO2 generated over the course of the incubation period, is an indication of significant mineralization and non-persistent nature of the parent compound.

 

Thus, based on the available information, it indicates thattest chemicalwas likely to be not persistent (not P) in nature.

 

Bioaccumulation assessment

The tested substance does not fulfil the B criterion within Annex XIII based on the assessment that here follows:

 

The octanol water partition coefficient (logKow) of the test chemical (i.e., 30.7% of 2-phenylethyl phenol (2-MSP) and 67.5% of 4-phenylethyl phenol (4-MSP)) was evaluated as per OECD TG 117 and EU Method A. 24 and determined to be 2.99 for 4-MSP and 3.13 for 2-MSP at 23.6°C with an weighted average mean value of logKow as 3.03, which is less than the threshold of 4.5. If this chemical is released into the aquatic environment, there should be a low risk for the chemical to bioaccumulate in fish and food chains.

 

Toxicity assessment

The tested substance does not fulfil the T criterion within Annex XIII based on the assessment that here follows:

 

Mammals

The tested chemical is regarded to be not classified for carcinogenicity, mutagenicity and reprotoxicity, Further, 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).

 

Aquatic organisms

All of the available short-term eco-toxicity data for fish, invertebrates and algae for the test chemical indicates the LC50/EC50 value to be in the range > 1 to 24 mg/L, respectively whereas on the basis of long term toxicity to aquatic invertebrates, the 21 days NOEC & EC50 value was determined to be 0.2 mg/l & 1.5 mg/l, respectively. These value suggest that the substance is likely to be hazardous to aquatic organisms at environmentally relevant concentrations.

 

On the basis of long term toxicity to fish study as per OECD TG 234 of 4-(1 -phenylethyl)-phenol (4-MSP), the 21 d NOEC value was determined to be in the range of 0.0618 to > 0.18 mg/l, respectively. Based on the OECD TG 210 study of 2,4,6-tris(1-phenylethyl)phenol, the 21 d NOEC value was determined to be 0.2 mg/l.

 

Hence, by speculation, long-term NOEC for aquatic organisms were not expected for the substance at concentration below 0.01 mg/L based on the data mentioned above.

 

The chemical was therefore not considered as hazardous to aquatic environments as per the criteria set out in Annex XIII.

 

Conclusion

Based on critical, independent and collective evaluation of information summarized herein, the tested compound does not fulfil the P, B and T criterion and has therefore not been classified as a PBT compound within Annex XIII.