C.I. Solvent Red 119

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 2017 - December 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

C.I. Solvent Red 119

EC Number:

602-676-8

Cas Number:

12237-27-3

Molecular formula:

C32H22N10O8Cr

IUPAC Name:

C.I. Solvent Red 119

impurity 1

Reference substance name:

Unknown impurities

Cas Number:

not available

IUPAC Name:

Unknown impurities

impurity 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Test material form:

solid: particulate/powder

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.12 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

One valid experiment was performed.
The study was performed using 5 concentrations ranging from 0.02 to 0.2 mg/L. During
validation the estimated solubility of the test item in test media was 0.174 mg/L. Therefore,
the concentration 0.2 mg/L was chosen as highest test concentration. For each test concentration
and the blank/solvent control, 20 Daphnia were exposed to the test item for 48
hours in a static test system. After 24 and 48 hours, the immobilised Daphnia were counted.
The highest concentration showed toxicity of 65 % immobilisation. None of the animals
was immobilised in the lower concentrations and the blank control.
Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a
current reference study to assure that the test conditions are reliable.
At the beginning and at the end of the test, the content of the test item in the test solutions
was determined using a photometer. The measured concentrations lay between 50 % and
68 % of the nominal concentrations at the beginning of the test and between 70 % and
105 % of the nominal concentrations at the end of the test. The measured concentrations
of the lower treatments (blank control, solvent control and concentrations 0.02 - 0.03 mg/L)
are below the LOQ.
Since toxicity/mortality occurred only in the highest concentration, only the 3 highest concentrations
are used for statistical evaluation.
The geometric mean values of the measured concentrations are formed for this purpose.
No observations were made which might cause doubts concerning the validity of the study
outcome. All validity criteria were met.
The result of the test is considered valid.

Executive summary:

One valid experiment was performed.

The study was performed using 5 concentrations ranging from 0.02 to 0.2 mg/L. During

validation the estimated solubility of the test item in test media was 0.174 mg/L. Therefore,

the concentration 0.2 mg/L was chosen as highest test concentration. For each test concentration

and the blank/solvent control, 20 Daphnia were exposed to the test item for 48

hours in a static test system. After 24 and 48 hours, the immobilised Daphnia were counted.

The highest concentration showed toxicity of 65 % immobilisation. None of the animals

was immobilised in the lower concentrations and the blank control.

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a

current reference study to assure that the test conditions are reliable.

At the beginning and at the end of the test, the content of the test item in the test solutions

was determined using a photometer. The measured concentrations lay between 50 % and

68 % of the nominal concentrations at the beginning of the test and between 70 % and

105 % of the nominal concentrations at the end of the test. The measured concentrations

of the lower treatments (blank control, solvent control and concentrations 0.02 - 0.03 mg/L)

are below the LOQ.

Since toxicity/mortality occurred only in the highest concentration, only the 3 highest concentrations

are used for statistical evaluation.

The geometric mean values of the measured concentrations are formed for this purpose.

The following results were determined for the test item Solvent Red 119 (species: Daphnia

magna).

48h-NOEC = 0.07 mg/L

48h-LOEC = 0.13 mg/L

24h-EC50 = 0.00 mg/L

48h-EC50 = 0.12 mg/L

Note: According to the guideline, NOEC is determined by comparing of the respective

treatment with the blank control. Statistically insignificant variation is considered as “no

observed effect”, although the EC which is read from the graph toxicity vs. concentration

may lie lower.