4,4'-oxydianiline

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Year is specified as 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is dated from 1980 and briefly reported. Nominal test concentrations were used. No positive control is reported. Results taken from TSCA fiche OTS0546071.

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)

Deviations:

yes

Remarks:

minor deviation with no impact on the final results

Principles of method if other than guideline:

Procedures used in the acute toxicity test closely followed those described in the MIC Environmental Assessment Method for Conducting Acute Toxicity Tests with Daphnia magna (Grueber and Adams, 1980), and Methods for Acute Toxicity Tests with Fish, Macroinvertebrates, and Amphibians (U.S. EPA, 1975).

GLP compliance:

not specified

Remarks:

Not specified.

Analytical monitoring:

no

Details on sampling:

- Concentrations: Nominal test concentrations were 0 (control), 0 (solvent control), 0.15, 0.31, 0.62, 1.25, 2.5, and 5 mg/L.
- Sampling method: For each test concentration, the test substance, dissolved in dimethylformamide, was injected into dilution water using a microliter syringe and stirred vigorously for 3-5 minutes. The solution was then divided into aliquots in triplicate beakers to provide appropriate replication. The remaining solution was used for 0-hour dissolved oxygen, pH, alkalinity, and hardness determinations. A control, consisting of the same dilution water and conditions, but with no test substance was used, as was a solvent control.
- Sample storage conditions before analysis: All test vessels were maintained at room temperature. Test solutions were not aerated during the test.

Vehicle:

yes

Details on test solutions:

The static toxicity tests were conducted in 250 mL beakers that contained 200 mL of test solution. The dilution water used was a mixture of distilled deionized water and well water from St. Peters, MO. The well water was diluted with distilled water to provide a hardness of approximately 60 ppm. For each test concentration, the test substance, dissolved in dimethylformamide, was injected into dilution water using a microliter syringe and stirred vigorously for 3-5 minutes. The solution was then divided into aliquots in triplicate beakers to provide appropriate replication. The remaining solution was used for 0-hour dissolved oxygen, pH, alkalinity, and hardness determinations. A control, consisting of the same dilution water and conditions, but with no test substance was used, as was a solvent control.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia Magna
- Strain: Not specified.
- Source: Not specified.
- Age at study initiation (mean and range, SD): Not specified.
- Weight at study initiation (mean and range, SD): Not specified.
- Length at study initiation (length definition, mean, range and SD): Not specified.
- Valve height at study initiation, for shell deposition study (mean and range, SD): Not specified.
- Peripheral shell growth removed prior to test initiation: Not specified.
- Method of breeding: Not specified.
- Feeding during test Not specified.
- Food type: Not specified.
- Amount: Not specified.
- Frequency: Not specified.

ACCLIMATION
- Acclimation period: Not specified.
- Acclimation conditions (same as test or not): Not specified.
- Type and amount of food: Not specified.
- Feeding frequency: Not specified.
- Health during acclimation (any mortality observed): Not specified.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

None.

Hardness:

hardness ranged from 60-72 mg/L

Test temperature:

Temperatures ranged from 21.9-23.8°C.

pH:

pH 7.8-8.4

Dissolved oxygen:

Dissolved oxygen ranged 7.9-9.0 mg/L

Salinity:

Not applicable.

Nominal and measured concentrations:

Nominal test concentrations were 0 (control), 0 (solvent control), 0.15, 0.31, 0.62, 1.25, 2.5, and 5 mg/L.

Details on test conditions:

TEST SYSTEM
- Test vessel: 250 mL beakers that contained 200 mL of test solution
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: Not specified.
- Aeration: No
- Type of flow-through (e.g. peristaltic or proportional diluter): None; static
- Renewal rate of test solution (frequency/flow rate): None; static
- No. of organisms per vessel: Ten daphnids were randomly assigned to each test vessel
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): Not applicable.
- No. of vessels per vehicle control (replicates): 3
- Biomass loading rate: Not specified.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: A mixture of distilled deionized water and well water from St. Peters, MO
- Total organic carbon: Not specified.
- Particulate matter: Not specified.
- Metals: Not specified.
- Pesticides: Not specified.
- Chlorine: Not specified.
- Alkalinity: 78-100 mg/l
- Ca/mg ratio: Not specified.
- Conductivity: Not specified.
- Culture medium different from test medium: Not specified.
- Intervals of water quality measurement: Beginning and end of test.

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: Not specified.
- Light intensity: Not specified.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Not specified.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Not specified.
- Justification for using less concentrations than requested by guideline: Not specified.

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

0.92 mg/L

Nominal / measured:

nominal

Conc. based on:

dissolved

Basis for effect:

mortality

Remarks on result:

other: 95% CL (0.84-1.01 mg/L)

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

4.52 mg/L

Nominal / measured:

nominal

Conc. based on:

dissolved

Basis for effect:

mortality

Remarks on result:

other: 95% CL (3.60-6.60 mg/L).

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

0.62 mg/L

Nominal / measured:

nominal

Conc. based on:

dissolved

Basis for effect:

mortality

Details on results:

During the 48-hours toxicity test, the pH and dissolved oxygen ranged from 7.8-8.4 and 7.9-9.0 mg/L, respectively. Temperatures ranged from 21.9-23.8°C. Alkalinity and hardness ranged from 78-100 and 60-72 mg/L, respectively.

Mortality ratios were 2/30, 1/30, 0/30, 2/30, 1/30, 27/30, 30/30, and 30/30 at 0 (control), 0 (solvent control), 0.15, 0.31, 0.62, 1.25, 2.5, and 5 mg/L, respectively. The no observed effect concentration (NOEC) at 48 hours was 0.62 mg/L. The 24-hour LC50 was 4.52 mg/L (3.60-6.60 mg/L).

Results with reference substance (positive control):

Not applicable.

Reported statistics and error estimates:

Not reported.

Mortality ratios were 2/30, 1/30, 0/30, 2/30, 1/30, 27/30, 30/30, and 30/30 at 0 (control), 0 (solvent control), 0.15,

0.31, 0.62, 1.25, 2.5, and 5 mg/L, respectively.

Validity criteria fulfilled:

not specified

Conclusions:

The substance demonstrated as very toxic to Daphnia Magna in the conditions of the test.

Executive summary:

An acute toxicity test was conducted with Daphnia magna according to USEPA standard. The test used dimethylformamide as vehicle for the solubilisation of the substance and the substance is expected to be stable in water. Therefore, the LC50 -48h of 0.92 mg/l is considered as valid. The summary of this test was use in TSCA robust study summary.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

october 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A chronic toxicity test of 3,4'-oxydianiline was conducted with Ceriodaphnia according to US EPA Method. The result of the range finding test (mortality after 48h) is used as supporting information on acute toxicity of 4,4'-oxydianiline.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: US. EPA. 1994. Short-term Methods for estimating the chronic toxicity of effluents and receiving waters to freshwater organisms. 3rd Ed. EPA/600/4-91/002. US. Environmental Protection Agency, Environmental Monitoring System Laboratory, Cincinnati, Ohio

Deviations:

not specified

GLP compliance:

not specified

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material :
This substance is the structural analogue of 4,4'-oxydianiline, the substance subject to this registration.

Analytical monitoring:

no

Details on sampling:

Not applicable

Vehicle:

no

Details on test solutions:

The test material, 3,4'-oxydianiline was prepared from a sample supplied by DuPont Haskell Laboratory. The sample was shipped via courrier to EA's Aquatic Toxicology Laboratory in Sparks, Maryland. Upon receipt, the sample was logged in and assigned EA laboratory accession number AT2-519. Stocks of 3,4'-oxydianiline were prepared each day in moderately hard synthetic freshwater, and these stocks were used to dose the test solutions.

Test organisms (species):

Ceriodaphnia dubia

Details on test organisms:

Ceriodaphnia dubia (water flea) were raised in EA's culture facility using synthetic moderately hard water. the cultures were kept in an environmentally controlled room at 25°C with a 16-hour light/8-hour dark photoperiod. Organisms were fed daily with trout chow/yeat.cereal leaves solution supplemented with algae (S. capricornutum) as described in US EPA (1993) method. Gravid adults were reisolated the evening before the test to ensure that neonates were less than 24 hours old at test initiation. The neonated delected for the test were released within an 8-hour period from the time of reisolation, from broods of eight or more.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

6 d

Remarks on exposure duration:

The result (mortality after 48h) of the 6d range finding test with ceriodaphnia test is used as an acute toxicity test.

Post exposure observation period:

Not applicable

Hardness:

no data

Test temperature:

25°C +/- 1°C
Measured temperature: 24.0 to 25.5°C

pH:

6.0 - 9.0
Measured^pH: 7.9 to 8.3

Dissolved oxygen:

> 4.0 mg/L
Measured oxygen concentrations: 7.1 to 8.2 mg/L

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal concentrations were: 0 (control), 5, 50, 100, 500, 5000 µg/L

Details on test conditions:

Conductivity: 244-311 µS/cm

Reference substance (positive control):

yes

Remarks:

sodium chloride

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

224 µg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% CI is not calculated as in a range finding test, the interval between concentrations is quite large and does not allow an appropriate calculation for the confidence interval.

Details on results:

After 48h of test all ceriodaphnia died on concentrations 500 and 5000 µg/L. On the other concentrations at 100 µg/L and below, all ceriodaphnia were alive. Therefore, the LC50-48 is in the range 100 - 500 µg/L.

Results with reference substance (positive control):

Results with sodium chloride: IC25 = 920 mg/L NaCl. The acceptable control chart limits is 7.5 - 1207 mg/L. NaCl. Therefore the organisms are within the range of sensitivity for a validation of the results.

Nominal test concentration (µg/L 3,4'-oxydianiline)	48-h % survival	6-d % survival	Mean young production (neonates/organism +/-SD)
Control	100	100	29.6 (+/-13.3)
5	100	0	12.6 (+/-10.2)
50	100	100	14.0 (+/-14.6)
100	100	100	4.6 (+/-10.7)
500	0	0	0
5000	0	0	0

Validity criteria fulfilled:

yes

Conclusions:

A chronic toxicity test was conducted with ceriodaphnia dubia according to US EPA guideline. The result of mortality after 48h in the range finding test of the reproduction test with Ceriodaphnia dubia could be used as an indication for short term toxicity to aquatic invertebrates: LC50-48h = 224 µg/L 3,4'-oxydianiline

Executive summary:

A chronic toxicity test was conducted with ceriodaphnia dubia according to US EPA guideline. The result of the mortality in the range finding test is used as an indication of acute toxicity for aquatic invertebrates. The LC50 -48h is calculated at 224 µg/L 3,4'-oxydianiline. The validity criteria are fulfilled and the sensitivity of the invertebrates has been checked with a reference substance. The result with the reference substance is within the acceptable chart limits. Because this study is not initially designed for a result for an acute toxicity test, this result is used as supporting information for the acute toxicity to aquatic invertebrates.

Description of key information

An acute toxicity test was conducted with Daphnia magna according to USEPA standard.

The result of this short term toxicity test of 4,4'-oxydianiline with Daphnia magna is used as key value for the acute toxicity to aquatic invertebrates.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.92 mg/L

Additional information

An acute toxicity test was conducted on 4,4'-oxydianiline with Daphnia magna according to an EPA OPPTS method. The EC50 -48h is determined to be 0.92 mg/L (95% CL: 0.84 - 1.01 mg/L). The test is considered as valid and therefore the result can be used as the key information for acute toxicity toward aquatic invertebrates.

This result is supported by a test conducted on a similar substance: 3,4'-oxydianiline with Ceriodaphnia dubia. This test was designed as a chronic toxicity test for the reproduction of the inveretebrates. However, the range-finding test could be used as informative result for the assessment of the acute toxicity to aquatic invertebrates. In this range finding test, an EC50 (48h) of 0.22 mg/L was obtained. The confidence limit could be determined on such a range finding tests as the intervals between concentrations were too large. However this result indicates the same range of toxicity level for the aquatic invertebrates and therefore this result could be considered as a supportive information.