Reaction mass of 4,4'-isopropylidenediphenol and phenol

Toxicity to terrestrial arthropods

Link to relevant study record(s)

Reference

Endpoint:

toxicity to terrestrial 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

Test organisms (species):

Folsomia candida

Total exposure duration:

28 d

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

500 mg/kg soil dw

Nominal / measured:

meas. (not specified)

Conc. based on:

not specified

Basis for effect:

reproduction

Duration:

28 d

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

meas. (not specified)

Conc. based on:

not specified

Basis for effect:

mortality

Duration:

28 d

Dose descriptor:

LOEC

Effect conc.:

1 000 mg/kg soil dw

Nominal / measured:

meas. (not specified)

Conc. based on:

not specified

Basis for effect:

reproduction

Conclusions:

The NOECreproduction was 500 mg test item/kg soil (dw) in the 28-day chronic reproduction study with the collembolan, Folsomia candida.

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.

Description of key information

No effects on survival were observed in a chronic reproduction study with the collembolan Folsomia candida (Moser and Egeler, 2007b; Staples et al., 2010). A NOEC of 500 mg/kg soil was determined based on number of juveniles.

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for soil dwelling arthropods:

500 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 chronic reproduction study with the collembolan, Folsomia candida was performed to assess the effects of Bisphenol A on the terrestrial invertebrate when exposed via soil. The study was performed according to ISO guideline 11267. The LC50 value could not be calculated and can only be estimated as being > 1000 mg test item/kg soil (dw). The NOECreproduction was 500 mg test item/kg soil (dw) and accordingly the LOECreproduction 1000 mg test item/kg soil (dw). The EC50 for reproduction was not calculated and is estimated as being > 1000 mg test item/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.