4,4'-Isopropylidenediphenol, propoxylated

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

14 February 2011 - 1 March 2011

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Qualifier:

according to guideline

Guideline:

ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 1: Static Method)

Deviations:

yes

Principles of method if other than guideline:

No other information provided

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Stability in water: Not indicated
The water solubility at 20°C was determined to be 0.109 g/l using the flask method.

Analytical monitoring:

yes

Details on sampling:

Samples for possible analysis were taken from all test concentrations and the control according to the schedule below. In addition, the filter containing undissolved residue was kept for possible analysis.

Frequency: at t=0 h and t=96 h, in addition samples were taken at t = 48 h from solution containing 18% of the filtrate
Volume: 2 ml
Storage: Samples were stored in a freezer until analysis.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Preparation of test solutions started with a loading rate of 100 mg/l applying a two-day period of magnetic stirring followed by a filtration through a 0.45 µm membrane filter (rs55, Whatman) to remove undissolved material. The lower test concentrations were prepared by subsequent dilutions of the highest loading rate in test medium. The final test solutions were all clear and colourless.

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands.

Mean length: Range-finding test: 3.5 ± 0.5 cm, Final test: 2.1 ± 0.1 cm

Mean weight: Range-finding test:1.41 ±0.57 g, Final test: 0.22 ± 0.04 g

Characteristics: F1 from a single parent-pair bred in UV-treated water.

Reason for selection: This system has been selected as an internationally accepted species.

Total fish used : 54

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

no

Hardness:

hardness of 180 mg CaCO3 per litre

Test temperature:

21.0-21.6

pH:

7.4 - 7.7

Dissolved oxygen:

6.9-9.7 mg/l

Salinity:

not measured

Nominal and measured concentrations:

Analysis of the samples taken at the start of the final test showed measured concentrations of 8.3, 16, 28, 47 and 85 mg/l in the 10, 18, 32, 56 and 100% of the filtrate prepared at a loading rate of 100 mg/l, respectively. The measured concentrations remained stable during the test (95-97%).

Details on test conditions:

Test vessels: 6.5 litres, all-glass, containing 4 litres of test solution
Test medium: Adjusted ISO medium with a hardness of 180 mg CaCO3 per litre and a pH of 7.7 ± 0.3.
Number of fish: 7 per concentration
Loading: 0.39 g fish/litre, i.e. 7 fish per 4 litres of test medium
Illumination: 16 hours photoperiod daily
Aeration: The test media were not aerated during the test.
Feeding: No feeding from 24 hours prior to the test and during the total test period
Introduction of fish: Within 40 minutes after preparation of the test media from a holding tank with comparable water quality parameters and pH and temperature differences between test and holding tank media of less than 0.5 unit and 0.5°C.
Euthanasia: At the end of the test the surviving fish were rapidly killed by exposing them to ca. 1.2% ethylene glycol monophenylether in water.

Reference substance (positive control):

yes

Remarks:

pentachlorophenol

Duration:

2.5 h

Dose descriptor:

LC50

Effect conc.:

21 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 16-28

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

13 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 11-16

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

12 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 8.3-16

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

9.1 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: estimated

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

8.8 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: estimated

Details on results:

The responses recorded in this test allowed for reliable determination of an LC50. No mortality or clinical effects were observed in the control treatment during the test. Fish exposed to 28, 48 and 85 mg/l died within the first 2½ hours of exposure. All fish exposed to 16 mg/l died within 48h of exposure, while 2 fish had died after 72 hours of exposure in the lowest treatment.

Results with reference substance (positive control):

- Results with reference substance valid? yes

The 96h-LC50 for carp exposed to PCP was estimated to be 0.15 mg/l (95 % confidence interval between 0.10 and 0.22 mg/l). This effect was already reached within 24 hours of exposure.

Reported statistics and error estimates:

The 24, 72 and 96h-LC50 values were determined using the maximum likelihood estimation method with the probits of the percentages of dead fish as function of the logarithms of the corresponding concentrations (Finney, D.J., 1971: Probit analysis, Cambridge University Press, Cambridge, U.K., 3rd edition). Because at t=72h and t=96h only two concentrations were available for analysis, the LC50 could be only estimated and no 95% confidence interval could be calculated.

As there was no concentration between the highest concentration (A) at which 0% mortality and the lowest concentration (B) at which 100% mortality occurred the 2½ and 48h-LC50 LC50 were calculated as (AB)½, with A and B being limits of the 95% confidence interval.

Sublethal observations / clinical signs:

Incidence of mortality and total mortality during the final test

Initial concentration LIN10001:4,4’-Isopropylidenediphenol, propoxylated (mg/l)	Initial number of fish	Cumulativemortality					Total Mortality (%)
		2½h	24h	48h	72h	96h
control	7	0	0	0	0	0	0
8.3	7	0	0	0	1	2	29
16	7	0	6	7	7	7	100
28	7	7	7	7	7	7	100
47	7	7	7	7	7	7	100
85	7	7	7	7	7	7	100

 

Clinical effects observed during the final test.

Initial concentration LIN10001:4,4’-Isopropylidenediphenol, propoxylated (mg/l)	Time of recording (hours)	Specification of effects	Relative number
8.3         16	24 48 72 96   2½ 24	Immobile Immobile Immobile Immobile   Hypoactive swimming Immobile	1/7 2/7 6/6 5/5   7/7 1/1

Validity criteria fulfilled:

yes

Conclusions:

The 96h-LC50 was estimated to be 8.8 mg/l based on initially measured concentrations.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Principles of method if other than guideline:

Due to low solubility of the substance, 500 mg/l was dispersed and filtered to obtain a saturated solution.

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Samples taken of fresh and old media at 0, 24, 48, 72 and 96 hours

Vehicle:

not specified

Details on test solutions:

Concentrations of 0.64, 6.4 and 64 mg/l were tested in a range finder.
100% mortality at 64 mg/l and 100 % survival at 6.4 mg/l (but with clinical signs of loss of equilibrium)
Main study nominal concentrations were 2.0, 3.6, 6.4, 10 and 20 mg/l

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Test type:

semi-static

Water media type:

freshwater

Total exposure duration:

96 h

Test temperature:

14-15°C

pH:

Typical measurement of pH 7.9 - 8.3 This is considered high pH for trout

Dissolved oxygen:

In range of 9.2 - 9.9 mg/l

Salinity:

n/a

Nominal and measured concentrations:

Recovery during validation was ca 99%, but during testing, recovery was > 100%. The lower nominal figures were used for reporting.
This is not considered to have affected the outcome of the study.

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

8.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks:

and sub-lethal effects

Remarks on result:

other: 95% CL = 6.4-12 mg/L

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

11 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks:

and sub-lethal effects

Remarks on result:

other: 95% CL = 7.8-15 mg/L

Details on results:

Clinical signs seen at 6.4 mg/l and higher, including loss of equilibrium

Sublethal observations / clinical signs:

Nominal NOEC = 3.6 mg/L

Mean measures NOEC = 4.4 mg/L

Validity criteria fulfilled:

yes

Conclusions:

The test substance was determined to be toxic to fish at the tested concentrations. The LC50 was found to be 8.8 mg/L.

Executive summary:

The acute toxicity potential of the substance was determined in accordance with the OECD Guideline for Testing of Chemicals 203. The substance was tested on rainbow trout at concentrations between 2 and 20 mg/L. An LC₅₀ of 8.8 mg/L and a NOEC of 3.6 mg/L were found based on nominal concentrations.

It is not considered justifiable to perform further animal testing to confirm toxicity. It is worth noting that the analysed concentrations were significantly higher than the nominal concentrations. There is no reason for this explained in the test report, but the lower (nominal) concentrations are used to estimate the LC₅₀ and NOEC level. 

Description of key information

The registered substance was found to demonstrate toxicity to fish at the tested concentrations.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

8.8 mg/L

Additional information

Two studies were conducted on the substance to determine the aquatic toxicity to fish. The studies were both conducted in accordance with the OECD Guideline for Testing of Chemicals 203. The key study was conducted using Cyprinus carpio in static test conditions with the read-across substance BPA 2PO. The 96 hour LC₅₀ was found to be 8.8 mg/L. The results of the supporting study using BPA 5PO, conducted using Oncorhynchus mykiss in a semi-static test, are in agreement with the results of the key study and demonstrate a 96 hour LC₅₀ of 8.8 mg/L. The results of testing on the two substances were similar, regardless of the number of propoxylations.