1-(2-methyl-4-(2-methylphenylazo)phenylazo)-2-naphthol

Bioaccumulation: aquatic / sediment

Link to relevant study record(s)

Reference

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from authoritative databases and secondary source

Qualifier:

according to guideline

Guideline:

other: "Bioaccumulation test of a chemical substance in fish or shellfish" provided in "the Notice on the Test Method Concerning New Chemical Substances"

Principles of method if other than guideline:

Bioaccumulation study was conducted on test organism Cyprinus carpio for 6 weeks for evaluating the bioconcentration factor (BCF value) of test chemical. The study was performed according to other guideline "Bioaccumulation test of a chemical substance in fish or shellfish" provided in "the Notice on the Test Method Concerning New Chemical Substances", respectively.

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material (IUPAC Name): 1-(2-Methyl-4-(2-methylphenylazo)phenylazo)-2-naphthol
- Common name: Sudan IV
- Molecular formula: C24H20N4O
- Molecular weight: 380.449 g/mol
- Smiles notation: c12c(\N=N\c3c(cc(\N=N\c4c(cccc4)C)cc3)C)c(ccc1cccc2)O
- InChI: 1S/C24H20N4O/c1-16-7-3-6-10-21(16)26-25-19-12-13-22(17(2)15-19)27-28-24-20-9-5-4-8-18(20)11-14-23(24)29/h3-15,29H,1-2H3/b26-25+,28-27+
- Substance type: Organic
- Purity: ca. 98%
- Water solubility: insoluble

Radiolabelling:

not specified

Vehicle:

yes

Details on preparation of test solutions, spiked fish food or sediment:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances) - Chemical name of vehicle: HCO-40, Crystal sugar, - Concentration of vehicle: 　1st Concentration area: HCO-40 3500 ppb(w/v), Crystal sugar 3500 ppb(w/v), 　2nd Concentration area: HCO-40 350 ppb(w/v), Crystal sugar 340 ppb(w/v)

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Carp
- Length at study initiation (lenght definition, mean, range and SD): 8
- Sex: MF

Route of exposure:

aqueous

Test type:

flow-through

Water / sediment media type:

natural water: freshwater

Total exposure / uptake duration:

6 wk

Test temperature:

25°C

pH:

6.0-8.5

Details on test conditions:

RANGE-FINDING / PRELIMINARY STUDY
- Test concentrations : TLm(48h) ≥ 100 ppm (w/v), Rice fish (Oryzias latipes

Nominal and measured concentrations:

Nominal concentrations:
1st concentration area: 0.35 mg/l (350 ppb(w/v))
2nd concentration area: 0.035 mg/l (35.0 ppb(w/v))

Reference substance (positive control):

not specified

Conc. / dose:

0.35 mg/L

Type:

BCF

Value:

> 0.29 - < 2.9 L/kg

Basis:

whole body w.w.

Time of plateau:

6 wk

Remarks on result:

other: Other details not known

Conc. / dose:

0.035 mg/L

Type:

BCF

Value:

> 2.9 - < 11 L/kg

Basis:

whole body w.w.

Time of plateau:

6 wk

Remarks on result:

other: Other details not known

Bioaccumulation test results:

 

		2 W	3 W	4 W	6 W
1st Concentration area	Test substance concentration (ppb (w/v))	338	334	334	339
	Bioconcentration factor (L/kg)	0.78	1.2	0.60	2.7
		≤0.29	0.69	≤0.29	2.9
2nd Concentration area	Test substance concentration (ppb (w/v))	33	34.7	34.9	35.3
	Bioconcentration factor (L/kg)	8.3	≤0.29	≤0.29	3.9
		4.7	4.4	11	≤0.29

Validity criteria fulfilled:

not specified

Conclusions:

The bioconcentration factor (BCF value) of test chemical on Cyprinus carpio was determined to be in the range of 0.29-2.9 L/Kg at a conc. of 0.35 mg/l and 2.9-11 L/Kg at a conc. of 0.035 mg/l, respectively.

Executive summary:

Bioaccumulation study was conducted on test organism Cyprinus carpiofor 6 weeks for evaluating the bioconcentration factor (BCF value) of test chemical.The study was performed according to other guideline"Bioaccumulation test of a chemical substance in fish or shellfish" provided in "the Notice on the Test Method Concerning New Chemical Substances" under flow through conditions at a temperature of25°C and pH range 6.0-8.5, respectively.Cyprinus carpio (length - 8 dimensionless) was used as a test organism for the study. Test chemical was prepared inHCO-40.Test chemical nominal conc. used for the study was 0.35mg/land 0.035 mg/l, respectively. Analytical method involve therecovery ratio:Test water: 98.3 %, Fish : 96.7 %, - Limit of quantitation : Test water :1st concentration area : 100 %, 2nd concentration area : 98.6 %, Fish : 90.8 %, - Limit of detection : Fish : 0.103 ppm.Range finding study involve theTLm(48h) ≥ 100 ppm (w/v) on Rice fish (Oryzias latipes).The bioconcentration factor (BCF value) of test chemical on Cyprinus carpio was determined to be in the range of 0.29-2.9 L/Kg at a conc. of 0.35 mg/l and 2.9-11 L/Kg at a conc. of 0.035 mg/l, respectively, which does not exceed the bioconcentration threshold of 2000, indicating that the test chemical is not expected to bioaccumulate in the food chain.

Description of key information

Bioaccumulation study was conducted on test organism Cyprinus carpiofor 6 weeks for evaluating the bioconcentration factor (BCF value) of test chemical (from authoritative database and secondary source).The study was performed according to other guideline"Bioaccumulation test of a chemical substance in fish or shellfish" provided in "the Notice on the Test Method Concerning New Chemical Substances" under flow through conditions at a temperature of25°C and pH range 6.0-8.5, respectively.Cyprinus carpio (length - 8 dimensionless) was used as a test organism for the study. Test chemical was prepared inHCO-40.Test chemical nominal conc. used for the study was 0.35mg/land 0.035 mg/l, respectively. Analytical method involve therecovery ratio:Test water: 98.3 %, Fish : 96.7 %, - Limit of quantitation : Test water :1st concentration area : 100 %, 2nd concentration area : 98.6 %, Fish : 90.8 %, - Limit of detection : Fish : 0.103 ppm.Range finding study involve theTLm(48h) ≥ 100 ppm (w/v) on Rice fish (Oryzias latipes).The bioconcentration factor (BCF value) of test chemical on Cyprinus carpio was determined to be in the range of 0.29-2.9 L/Kg at a conc. of 0.35 mg/l and 2.9-11 L/Kg at a conc. of 0.035 mg/l, respectively, which does not exceed the bioconcentration threshold of 2000, indicating that the test chemical is not expected to bioaccumulate in the food chain.

Key value for chemical safety assessment

BCF (aquatic species):

0.29 L/kg ww

Additional information

Experimental studies and predicted data of the test chemical were reviewed for the bioaccumulation end point which are summarized as below:

 

In an experimental key study from authoritative database and secondary source (2018),bioaccumulation experiment was conducted on test organism Cyprinus carpio for 6 weeks for evaluating the bioconcentration factor (BCF value) of test chemical. The study was performed according to other guideline "Bioaccumulation test of a chemical substance in fish or shellfish" provided in "the Notice on the Test Method Concerning New Chemical Substances" under flow through conditions at a temperature of25°C and pH range 6.0-8.5, respectively. Cyprinus carpio (length - 8 dimensionless) was used as a test organism for the study. Test chemical was prepared inHCO-40.Test chemical nominal conc. used for the study was 0.35mg/land 0.035 mg/l, respectively. Analytical method involve the recovery ratio: Test water: 98.3 %, Fish : 96.7 %, - Limit of quantitation : Test water :1st concentration area : 100 %, 2nd concentration area : 98.6 %, Fish : 90.8 %, - Limit of detection : Fish : 0.103 ppm. Range finding study involve the TLm(48h) ≥ 100 ppm (w/v) on Rice fish (Oryzias latipes).The bioconcentration factor (BCF value) of test chemical on Cyprinus carpio was determined to be in the range of 0.29-2.9 L/Kg at a conc. of 0.35 mg/l and 2.9-11 L/Kg at a conc. of 0.035 mg/l, respectively.

 

In a prediction done using the BCFBAF Program of Estimation Programs Interface was used to predict the bioconcentration factor (BCF) of test chemical. The bioconcentration factor (BCF) of test chemical was estimated to be 10 L/kg whole body w.w (at 25 deg C).

 

For the test chemical,bioaccumulation study was conducted for estimating the BCF (bioaccumulation factor) value of test chemical (HSDB, 2017). The bioaccumulation factor (BCF) value was calculated using a logKow of -0.14 and a regression-derived equation. The estimated BCF (bioaccumulation factor) value of test chemical was determined to be 0.5 dimensionless.

 

In a supporting study from authoritative database (2017),the bioaccumulation study in fish was conducted for estimating the BCF (bioaccumulation factor) value of test chemical. The bioaccumulation factor (BCF) value was calculated using a logKow of 3.81 and a regression-derived equation. The estimated BCF (bioaccumulation factor) valueof test chemical was determined to be 3 dimensionless.

 

On the basis of above results for test chemical, it can be concluded that the BCF value of test chemical was evaluated to beranges from0.29 to 10, respectively,which does not exceed the bioconcentration threshold of 2000, indicating that the test chemical is not expected to bioaccumulate in the food chain.