Reaction mass of 4,4'-isopropylidenediphenol and phenol

Toxicity to terrestrial plants

Link to relevant study record(s)

Reference

Endpoint:

toxicity to terrestrial plants: 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

GLP compliance:

yes

Total exposure duration:

21 d

Reference substance (positive control):

no

Species:

Zea mays

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

130 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Remarks:

Analytical confirmation of dose closely approximated the nominal

Basis for effect:

other: dry shoot weight

Species:

Avena sativa

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

47 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Remarks:

Analytical confirmation of dose closely approximated the nominal

Basis for effect:

other: dry shoot weight

Species:

Triticum aestivum

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

47 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Remarks:

Analytical confirmation of dose closely approximated the nominal

Basis for effect:

other: dry shoot weight

Species:

Brassica oleracea var. capitata

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

50 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Remarks:

Analytical confirmation of dose closely approximated the nominal

Basis for effect:

other: dry shoot weight

Species:

Glycine max (G. soja)

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

320 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Remarks:

Analytical confirmation of dose closely approximated the nominal

Basis for effect:

other: dry shoot weight

Species:

Lycopersicon esculentum

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

20 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Remarks:

Analytical confirmation of dose closely approximated the nominal

Basis for effect:

other: dry shoot weight

Validity criteria fulfilled:

yes

Conclusions:

An OECD Guideline 208 study assessing emergence and growth in 6 different species of terrestrial plant exposed to Bisphenol A was performed. The plant species tested were three monocotyledons, corn (Zea mays), oats (Avena sativa) and wheat (Triticum aestivum), and three dicotyledons, cabbage (Brassica oleracea), soybean (Glycine max) and tomato (Lycopersicon esculentum). For the endpoint of percent emergence, there were no effects at the highest dose tested with oat, soybean, corn, and wheat. Tomato and cabbage were equally sensitive for the endpoint percent emergence with an LOEC of 320 mg/kg dw and a NOEC of 130 mg ai/kg dw. The dry shoot weight endpoint, an assessment of growth, there were effects in all species. The most sensitive species was tomato with a LOEC and a NOEC of 50 and 20 mg/kg dw, respectively.

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

An OECD 208 study in 6 plant species was performed with Bisphenol A (Hoberg, 2007; Staples et al., 2010). The most sensitive plant was tomato with a LOEC and NOEC of 50 mg/kg dw soil and 20 mg/kg dw soil, respectively.

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for terrestrial plants:

20 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

An OECD Guideline 208 study assessing emergence and growth in 6 different species of terrestrial plant exposed to Bisphenol A was performed (Hoberg, 2007; Staples et al., 2010). The plant species tested were three monocotyledons, corn (Zea mays), oats (Avena sativa) and wheat (Triticum aestivum), and three dicotyledons, cabbage (Brassica oleracea), soybean (Glycine max) and tomato (Lycopersicon esculentum). For the endpoint of percent emergence, there were no effects at the highest dose tested with oat, soybean, corn, and wheat. Tomato and cabbage were equally sensitive for the endpoint percent emergence with an LOEC of 320 mg/kg dw and a NOEC of 130 mg /kg dw. There were effects on dry shoot weight endpoint, an assessment of growth, in all species tested. The most sensitive species was tomato with a LOEC and a NOEC of 50 and 20 mg/kg dw, respectively.

 

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.