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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
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:
other: E729-80
GLP compliance:
yes
Analytical monitoring:
yes
Vehicle:
no
Test organisms (species):
Daphnia magna
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
144 mg/L CaCO3
Test temperature:
19.8 to 20.4 °C
pH:
8.1
Conductivity:
270 umhos/cm
Reference substance (positive control):
no
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
10.2 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
act. ingr.
Basis for effect:
mortality

Analytical: Bisphenol A was found to be stable at all test concentrations. The nominal concentrations for this study were 0 (control), 0.93, 1.55, 2.60, 4.32, 7.20, 12, and 20 mg/L. The average analyzed concentrations were ND, 0.90, 1.46, 2.49, 4.11, 6.97, 11.66, and 19.34 mg/L. Daphnid Acute Test: Bisphenol A, 24 hour and 48 hour acute EC50 with a 95 % confidence interval using the mean analyzed concentration was 15.5 mg/L (14.4-16.7) and 10.2 (9.2-11.4) mg/L respectively. Water Quality: Temperature in the beakers ranged from 19.8 to 20.4°C, pH from 8.0-8.3, the lowest recorded DO value was 96 % of saturation at 20 °C.

Validity criteria fulfilled:
yes
Conclusions:
A 48-hr Daphnia magna acute study under static conditions was performed. Daphnia were exposed to nominal concentrations ranging from 0.93 to 20.0 mg/L and a control. These nominal concentrations corresponded to measured concentrations ranging from 0.90 to 19.34 mg/L. The 24-hr and 48-hr EC50 values (and 95 % confidence intervals) were 16 (14 -17) and 10 (9.2 -11) mg/L Bisphenol A, respectively.
Executive summary:

A 48-hr Daphnia magna acute study under static conditions was performed. Daphnia were exposed to nominal concentrations ranging from 0.93 to 20.0 mg/L and a control. These nominal concentrations corresponded to measured concentrations ranging from 0.90 to 19.34 mg/L. The 24-hr and 48-hr EC50 values (and 95 % confidence intervals) were 16 (14 -17) and 10 (9.2 -11) mg/L Bisphenol A, respectively.

Endpoint:
short-term toxicity to aquatic invertebrates
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:
other: ASTM E729-80
Principles of method if other than guideline:
not relevant
GLP compliance:
yes
Specific details on test material used for the study:
BPA
Lot No. TB 84071221
Purity: 99.93%
Analytical monitoring:
yes
Vehicle:
no
Test organisms (species):
Americamysis bahia (previous name: Mysidopsis bahia)
Test type:
flow-through
Water media type:
saltwater
Limit test:
no
Total exposure duration:
96 h
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
0.51 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
EC50
Effect conc.:
1.1 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
act. ingr.
Basis for effect:
mortality

Nominal Concentrations in mg/L were 0, 0.89, 1.4, 2.1, 3.2, 5.0 corresponding to measured concentrations in mg/L of 0, 0.51, 0.86, 1.4, 1.9, 3.3, respectively. Analytical Monitoring: Results of QA and replicate samples indicated that sufficient analytical control occurred during testing. Water Quality: Dissolved oxygen concentration, pH, salinity, and temperature, monitored during exposure testing were all within satisfactory ranges for maintaining mysid health, per ASTM 1980. After 24 hours of exposure no mysid mortalities were recorded in the control, 0.51, and 0.86 mg/L. 15 % mortality was observed in mysids exposed to 1.4 and 1.9 mg/L of Bisphenol A. 50 % mortality occurred in mysids exposed to a Bisphenol A concentration of 3.3 mg/L. After 48 hours of exposure, mysids exposed to Bisphenol A concentrations of 0.51, 0.86, and 1.4 mg/L experienced less than or equal to a 20 % cumulative mortality rate while those exposed to concentrations of 1.9 and 3.3 mg/L exhibited 80 % and 100 % cumulative mortality respectively. For exposures lasting 72 and 96 hours, treatment levels of 0.51 and 0.86 resulted in cumulative mortality rates less than or equal to 20 % while the higher exposure concentrations produced cumulative mortality rates of at least 65 %. The 24-, 48-, 72-, and 96-hour LC50's (95 % confidence intervals) were calculated to be 3.3 (2.6-5.7), 1.6 (1.3-1.9), 1.2 (1.0-1.3), and 1.1 (0.92-1.2) mg/L, respectively. One mortality occurred in the control over the course of the study. The no discernable effect concentration in this study was found to be 0.51 mg/L. This concentration produced only one mortality among the 20 exposed mysids during the 96-hour study period.

Validity criteria fulfilled:
yes
Conclusions:
The study conducted by Springborn Bionomics, 1985b, is a fully reliable GLP and guideline study, which is appropriate to be used for regulatory purposes.
Executive summary:

A 96-hr acute flow-through mysid (Mysidopsis bahia) study was performed with nominal concentrations of 0, 0.89, 1.4, 2.1, 3.2, and 5.0 mg/L. These corresponded to measured concentrations of 0, 0.51, 0.86, 1.4, 1.9, and 3.3 mg/L, respectively. The 24-, 48-, 72-, and 96-hour LC50's (95 % confidence intervals) were calculated to be 3.3 (2.6-5.7), 1.6 (1.3-1.9), 1.2 (1.0-1.3), and 1.1 (0.92-1.2) mg/L, respectively. One mortality occurred in the control over the course of the study. The no discernable effect concentration in this study was found to be 0.51 mg/L. This concentration produced only one mortality among the 20 exposed mysids during the 96-hour study period.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 6 September 2005 to 8 September 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: EPA-540/9-85-005
GLP compliance:
yes
Specific details on test material used for the study:
BPA (CAS RN 80-05-7) used in all of the studies was from the same lot (purity 499.3%) and was sent to each of the testing laboratories from a central repository at RTI International, Research Triangle Park, NC, USA.
Analytical monitoring:
yes
Details on sampling:
In all cases, analytical measurements of test concentrations were performed using methods validated at Springborn Smithers Laboratories or ABC Laboratories, depending on the location of the study. Representative samples of the dilution water source and the food used in each test were analyzed periodically for the presence of pesticides, PCBs, and toxic metals and none have been detected at concentrations that are considered toxic (ASTM, 2002). In addition, representative samples of the dilution water source were analyzed monthly for total organic carbon (TOC) concentration. The TOC concentration of the dilution water source ranged from 0.84 to 1.6 mg/L during the Chironomus test.
Vehicle:
no
Details on test solutions:
BPA stock solutions for the midge amphipod studies were prepared by placing a measured quantity of BPA in a volumetric flask or other glass container and bringing it to the appropriate volume with reagent grade or deionized water. The stock solutions were adjusted to approximately pH 11 by adding 5M sodium hydroxide (NaOH) in a dropwise manner. The resulting stock solutions were continuously stirred and/or sonicated until the solutions contained no undissolved material. In addition, a pH buffer control stock solution was also prepared at approximately pH 11 for use in the tests.
Test organisms (species):
other: Chironomus tentans
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
During main study 21°C to 22 °C
Dissolved oxygen:
7.9 to 9.2 mg/L (89–103% of saturation)
Conductivity:
The culture and dilution water had total hardness and total alkalinity as calcium carbonate (CaCO3) of 48–54 and 30–34 mg/L, respectively, a pH of 7.2–7.6, and a specific conductance of 170–190 mmhos/cm.
Nominal and measured concentrations:
Nominal: 1.4, 2.1, 3.0, 5.5 and 9.4 mg/L. Concentrations ranged within 84% to 110%.
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
2.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
1.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Validity criteria fulfilled:
not specified
Conclusions:
The 96-h LC50 for midges exposed to BPA was determined by probit analysis to be 2.7 mg/L, with 95% confidence intervals of 2.1–3.2 mg/L.
Executive summary:

The 10% mortality in the lowest treatment level (1.4 mg/L) was considered to be within the normal range for control mortality, leading to a no-observed effect concentration of 1.4 mg/L for the study. The lowest-observed effect concentration was considered to be the next highest treatment level of 2.1 mg/L where there was 45% mortality.

The 96-h LC50 for midges exposed to BPA was determined by probit analysis to be 2.7 mg/L, with 95% confidence intervals of 2.1–3.2 mg/L.

Description of key information

There are three key studies which are scored Klimisch 1 (reliable without restriction) and which report of acute toxicity to invertebrates for fresh or marine water.

For fresh water the lowest effect level among these studies was reported by Springborn Smithers, 2005 (published in Mihaich et al., 2009) who determined a LC50 of 2.7 mg/L in an EPA-540/9-85-005 study with Chironomus tentans.

The lowest effect level for marine water was reported by Springborn Bionomics, 1985b (published in Alexander et al., 1988) with an LC50 of 1.1 mg/L in a ASTM E729-80 study with Americamysis bahia.

There was another Klimisch 1 fresh water study:

-       Alexander et al., 1985 (published in Alexander et al., 1988) reported an EC50 of 10.2 mg/L with Daphnia magna.

Both Springborn Smithers studies with the lowest effect levels in marine and fresh water were considered as key value for chemical safety assessment.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
LC50
Effect concentration:
2.7 mg/L

Marine water invertebrates

Marine water invertebrates
Dose descriptor:
LC50
Effect concentration:
1.1 mg/L

Additional information

The Klimisch 1 studies are supported by studies with minor restrictions which are scored Klimisch 2:

Tato et al., 2018, assessed effects on Acartia clausi in a study partly following ISO 14669 and report a LC50 of 0.885 mg/L. Mansilha et al. conducted a study with Daphnia magna according to OECD 202 and report an EC50 of 9.94 mg/L. Mu et al., 2005a, investigated effects on Daphnia magna according to EPA/660/3-75-009 method and reported an EC50 of 16 mg/L. Brennan et al., 2006, conducted an acute study with D. magna following ISO 6341 method and determined an EC50 of 7.8 mg/L. Stephenson et al., 1983, published a study according to EPA-660/3-75-009 with D. magna and reported an EC50 of 3.9 mg/L. Chen et al., 2002, performed an OECD 202 study with D. magna and reported an EC50 of 10 mg/L. Andersen et al., 2001, used Acartia tonsa to determine acute toxicity (ISO/DIS 14669 ) with a LC50 of 4.2 mg/L. Kusk & Wollenberger, 1999, published another ISO/DIS 14669 study with Acartia tonsa and reported an EC50 in the range of 3.4-5 mg/L. Marcial et al., 2003a, published an exploratory study with the copepod Tigriopus japonicus and reported of acute toxicity with an EC50 of 4.32 mg/L. Warbritton, 2005, performed an acute non-guideline snail study with Marisa cornuarietis which reported an EC50 of 2.24 mg/L. Hughes, 2006, conducted a study with Marisa cornuarietis following no guideline and reported an EC50 of > 4.03 mg/L. Pascoe et al., 2002a, conducted a study with Hydra vulgaris and reported an EC50 of 6.9 mg/L. Castritsi-Catharios, 2013, performed a test similar to a standard method developed at the Artemia Reference Center (ARC-Test) with Artemia franciscana and reported a 48-h LC50 of 34.7 mg/L. Li, 2013, reported an 48-h LC50 = 8.3 mg/L for Dugesia japonica.

Thus, there is a huge set of studies which support the key studies and L/EC50 values were in the range of 0.885 to 34.7 mg/L.

In contrast, several other acute studies which are listed and discussed in this chapter were rated as Klimisch 3 (not reliable) due to major short-comings or Klimisch 4 (not assignable) due to e.g. insufficient documentation and disregarded in the risk assessment. Full justifications for disregard are provided in the endpoint study records and the respective robust study summaries (e.g. Roepke et al., 2005, Andersen et al., 1999, Arslan and Parlak, 2007).

In conclusion, there are three Klimisch 1 key studies, two for the freshwater compartment (Alexander et al., 1985; published in Alexander et al., 1988, and Springborn Smithers, 2005) reporting a LC50 of 2.7 and an EC50 of 10.2 mg/L. Furthermore, there is one for the marine water compartment (Springborn Bionomics, 1985b; published in Alexander et al., 1988) with an LC50 of 1.1 mg/L. These studies were used for the risk assessment, while the CLP classification was based on the Springborn Bionomics, 1985 and Alexander, 1985, as only these report of crustacean data which is the relevant data following the CLP guidance document.