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EC number: 904-653-0 | CAS number: -
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to soil macroorganisms except arthropods: long-term
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that the properties of the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol can be predicted by studies conducted with the source substances phenol, 4,4’-isopropylidenediphenol (BPA), and 2-acetone, polymer with phenol, because the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol contains phenol (40-45%, typical concentration ca. 40%) and 4,4’-isopropylidenediphenol (BPA) (20-40%, typical concentration ca. 33%) as main constituents. Both constituents are data rich substances with distinct hazard properties, so that mainly data on the constituents have been applied to characterize the Reaction mass of phenol and 4,4’-isopropylidenediphenol. Since this is a common approach in mixture hazard assessment, is reasonable to apply it also to multi-constituent substances.
Additionally, some data from a structurally related substance (2-acetone, polymer with phenol) containing the same constituents/impurities at different concentrations are available, which are applied to characterize the environmental fate and ecotoxicity of the impurities present in the Reaction mass of phenol and 4,4’-isopropylidenediphenol.
This read-across hypothesis corresponds to scenario 2 - different compounds have qualitatively and quantitatively the same type of effects - of the read-across assessment framework i.e. properties of the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol are predicted to be similar to those of the source substances phenol, 4,4’-isopropylidenediphenol (BPA), and 2-acetone, polymer with phenol.
Therefore, read-across from the available studies with the source substances is considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
please refer to justification for read-across attached to Iuclid section 13
3. ANALOGUE APPROACH JUSTIFICATION
please refer to justification for read-across attached to Iuclid section 13
4. DATA MATRIX
please refer to justification for read-across attached to Iuclid section 13 - Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
- Total exposure duration:
- 28 d
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/kg soil dw
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- other: Reported as nominal
- Basis for effect:
- other: reproduction and mortality
- Duration:
- 28 d
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/kg soil dw
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- other: Reported as nominal
- Basis for effect:
- other: reproduction and mortality
- Conclusions:
- The NOECreproduction was estimated as being >100 mg/kg soil dw in a 28-day potworm (Enchytraeus crypticus) reproduction study.
Due to the physicochemical properties of Phenol, this major constituent of the reaction mass is capable of targeting aquatic and terrestrial wildlife through a different exposure route than 4,4’-isopropylidenediphenol. Therefore, to adequately characterize the hazard of the reaction mass toward ecotoxicology endpoints, the toxicity and fate of both major constituents of the reaction mass of phenol and 4,4’-isopropylidenediphenol were considered and two sets of PNECs (one for phenol one for 4,4’-isopropylidenediphenol) were derived and an assessment entity approach was applied. PNECsoil for phenol is derived using the equilibrium partitioning method in the absence of experimental data.
Reference
Description of key information
No effects on mortality or number of juveniles were observed in a 28-day potworm (Enchytraeus crypticus) reproduction study (Moser and Egeler, 2007a; Staples et al., 2010). A NOEC of 100 mg/kg dw was determined.
Key value for chemical safety assessment
- Long-term EC10, LC10 or NOEC for soil macroorganisms:
- 100 mg/kg soil dw
Additional information
The reaction mass of phenol and 4,4'-isopropylidenediphenol is manufactured and used under strictly controlled conditions, and thus there are no direct emissions to the environment. Direct or indirect exposure of the soil compartment is unlikely to occur, thus there is no need to investigate the effects on soil organisms.
Nevertheless, data on soil organisms are available for 4,4'-isopropylidenediphenol (Bisphenol A), which is one of the major constituents of the multi-constituent substance. A justification for read-across is attached to Iuclid section 13.
Study with Bisphenol A
A 28-day potworm (Enchytraeus crypticus) reproduction study was performed according to OECD Guideline 220. Radiolabeled Bisphenol A was mixed into artificial soil to achieve final concentrations of Bisphenol A in the test systems of 1.0, 9.5, 17.1, 30.9, 55.6, and 100 mg test item/kg soil dw (dry weight). A reference study with carbendazim was also performed to confirm the sensitivity of the test system. The test design consisted of 6 treatments plus a solvent control and a water control, 4 replicates per treatment, 8 replicates for the solvent control, and 10 potworms per test vessel. Study validity criteria were met. No effects on mortality or number of juveniles were observed at the highest dose tested of 100 mg/kg dw. Therefore, the NOECreproduction was estimated as being >100 mg/kg soil dw.
Due to the physicochemical properties of Phenol, this major constituent of the reaction mass is capable of targeting aquatic and terrestrial wildlife through a different exposure route than 4,4’-isopropylidenediphenol. Therefore, to adequately characterize the hazard of the reaction mass toward ecotoxicology endpoints, the toxicity and fate of both major constituents of the reaction mass of phenol and 4,4’-isopropylidenediphenol were considered and two sets of PNECs (one for phenol one for 4,4’-isopropylidenediphenol) were derived and an assessment entity approach was applied. PNECsoil for phenol is derived using the equilibrium partitioning method in the absence of experimental data.
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