4,4'-isopropylidenediphenol

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Endpoint:

toxicity to soil macroorganisms except arthropods: long-term

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 220 (Enchytraeid Reproduction Test)

GLP compliance:

yes

Analytical monitoring:

yes

Vehicle:

yes

Test organisms (species):

other: Enchytraeus sp.: (Worm (Annelida), soil dwelling)

Animal group:

annelids

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

no

Total exposure duration:

28 d

Reference substance (positive control):

yes

Remarks:

carbendazim

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

The measured radioactivity in the soil samples of the different concentrations was higher than the measured radioactivity in the dosage solutions of each concentration. The recovery of radioactivity from the soil samples ranged from 109.9% to 147.9% of that measured in the dosage solutions. However, since the radioactivity measured in the soil samples was higher than that measured in the dosage solutions, it can be concluded that the radio-labelled Bisphenol A dissolved in the 5 mL acetone dosage solutions was applied completely onto the appropriate amount of artificial soil (200 g). As the actual concentrations used in the test were in sufficient agreement with the nominal concentrations the nominal concentrations will be used to report the study findings.

Observed mortality was 7.5% in the solvent control and 5% in the deionised water control. The validity criterion for mortality is not to exceed 20% in the controls. Mortality in the 1.0, 9.5, 17.1, 30.9, 55.6 and 100 mg BPA/kg soil vessels was 5.0, 5.0, 12.5, 10.0, 7.5, and 7.5%, respectively. No differences in mortality were observed. Therefore, the LC50 value could not be calculated and can only be estimated as being > 100 mg test item/kg soil (dw).

The mean number of juveniles (sd) was 394.3 (64.5) in the solvent control and 375.3 (64.4) in the deionised water control. The validity criterion for mean number of juveniles is 50 juveniles per test vessel in the controls. Mean number of juveniles (sd) in the 1.0, 9.5, 17.1, 30.9, 55.6 and 100 mg BPA/kg soil vessels was 381.3 (112.6), 361.5 (81.1), 345.5 (61.5), 403.5 (131.1), 406.5 (62.5) and 321.0 (91.5), respectively. Statistical analysis (Dunnett's test; 1-sided, p = 0.05) showed no significant difference concerning the number of juveniles between the solvent control and all test item treatments. Therefore, the NOECreproduction is estimated as being 100 mg test item/kg soil (dw).

Validity criteria fulfilled:

yes

Executive summary:

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.

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

In addition to performing a chronic study with earthworms, Johnson et al. (2005a) performed a short-term, acute study. However, the acute study is considered unreliable for a number of reasons, including that the control survival did not meet the validity criteria and there were no effects in the chronic study at doses that caused mortality in the acute study. The inconsistency in results prompted a new, fully valid chronic study with the potworm Enchytraeus crypticus (Moser and Egeler, 2007a). Final concentrations of Bisphenol A in the test systems, consisting of artificial soil, were 1.0, 9.5, 17.1, 30.9, 55.6, and 100 mg test item/kg soil dw (dry weight). No effects on mortality or number of juveniles were observed at the highest dose tested of 100 mg/kg dw. This is in agreement with the findings from the earthworm chronic study (Johnson et al., 2005) where the NOEC of 100 mg/kg was also established.