Reaction mass of Amines, hydrogenated tallow alkyl and azelaic acid and lithium hydroxide

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was based on OECD guideline 203 and was GLP compliant. Therefore, the study has been given a reliability score of 1.

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

In the range-finding test the Total Organic Carbon concentration was determined with the TOC instead of NPOC method. As this is an equivalent alternative it was not considered to affect the outcome of the test.

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

yes

Remarks:

In the range-finding test the Total Organic Carbon concentration was determined with the TOC instead of NPOC method. As this is an equivalent alternative it was not considered to affect the outcome of the test.

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Not applicable

Analytical monitoring:

yes

Details on sampling:

The confirmatory chemical analysis was based on the concentration of the fatty acid component (azelate) and on the concentration of the lithium ion. The concentration of total organic carbon (TOC) was also measured.
Samples for analysis were taken from the control and the 100 mg/L treatment at the start of the test and after 96 hours of exposure and stored in a refrigerator (TOC) or freezer (lithium and azelate) until analysis.
For the determination of the test substance based on azelate, the samples were diluted in a 1:1 (v:v) ratio with 2% formic acid in acetonitrile and analysed. If necessary, the samples were further diluted with 1% formic acid in 50/50 (v/v) acetonitrile/ISO-medium to obtain concentrations within the calibration range.
For the determination of the test substance based on lithium the samples were diluted in a 24:1 (v:v) ratio with HNO3 and analysed. If necessary, the samples were further diluted with 4% HNO3 in ISO-medium to obtain concentrations within the calibration range.

Vehicle:

no

Details on test solutions:

- Solution: Adjusted ISO medium
- Solubility: The test item was completely soluble in test medium at the concentrations tested.
- Preparation of test solutions: A solution with a concentration of 100 mg/L was prepared by vigorous shaking to completely dissolve test substance in test medium.
- Appearance: The solutions were clear and colourless at test start. The controls remained clear and colourless during the test. The test solution was hazy from 72 hours and at the end of the test a floating layer and precipitate were observed.

Test organisms (species):

Cyprinus carpio

Details on test organisms:

- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands. F1 from a single parent-pair bred in UV-treated water
- Mean length: 2.9 ± 0.4 cm
- Mean weight: 0.69 ± 0.33 g
- Acclimatisation: At least 12 days, with daily feeding of pelleted fish food
- Validity: Mortality <5% during 7 days prior to start of test

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

None

Hardness:

180 mg CaCO3 per litre

Test temperature:

21-22°C

pH:

7.5-8.0

Dissolved oxygen:

5.2-8.7 mg/L

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal concentrations: 100 mg/L.
The measured concentrations based on azelate were at the level of 81-90% of nominal during the exposure period.
The measured concentrations based on lithium were at the level of 117% of nominal during the exposure period.
The control and test concentrations were measured at 0h and 96h. The measured concentrations at 0h were 0.26 and 59 mg TOC/L and at 96h they were 0.28 and 51 mg TOC/L. The TOC remained relatively stable throughout the test.

Details on test conditions:

TEST SYSTEM
- Test vessel: 10 L
- Material, fill volume: Glass, 8L
- Aeration: Aeration was introduced after 24 hours of exposure
- No. of organisms per vessel: 7

OTHER TEST CONDITIONS
- Photoperiod: 16 hours
- Feeding: None from 24 hours prior to test start
- Observations: 2.25, 24, 48, 72 and 96 hours for mortality and other effects

Reference substance (positive control):

yes

Remarks:

pentachlorophenol (PCP)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

No LC50 could be calculated because it exceeded the maximum concentration tested (LC50 >100 mg/L).

Results with reference substance (positive control):

The 96h-LC50 for carp exposed to PCP was 0.32 mg/L. The range of the 96h-LC50 for carp is generally between 0.10 and 0.46 mg/L. Hence, the sensitivity of carp originating from the present batch for PCP falls within the range of sensitivities generally observed during the past years.

Reported statistics and error estimates:

No data reported.

Validity criteria fulfilled:

yes

Remarks:

No mortality in control, test conditions were constant, dissolved oxygen >5 mg/L, measured concentrations at least 80% of nominal

Conclusions:

No LC50 could be calculated because it exceeded the maximum concentration tested (LC50 > 100 mg/L).

Executive summary:

The effect of dilithium azelate on the mortality of the carp (Cyprius carpio) was investigated according to an OECD 203 guideline and EC method C1. A 96 hour limit test at 100 mg/L was conducted under static conditions. At the start of the test all solutions were clear and colourless. The test solution was hazy from 72 hours and at the end of the test a floating layer and precipitate was observed. Analysis of the fatty acid (azelate) was between 81 and 90% nominal and the lithium concentration was 117% of nominal throughout the test. The total organic carbon (TOC) measured at the start of the test was 59 mg/L and at the end of the test was 51 mg/L. The test concentrations were considered to be maintained and the results are reported based on nominal concentrations. The study met all the validity criteria for the test. As no fish mortalities were observed in the test the LC50 is > 100 mg/L dilithium azelate.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: 92/69/EEC, C.1; OECD 203

Deviations:

no

GLP compliance:

yes

Details on test solutions:

Identity and concentration of auxiliary solvent for dispersal: Not necessary, because the test substance is directly solved in the test medium.

Test organisms (species):

other: Zebra fish (Brachydanio rerio)

Test type:

semi-static

Total exposure duration:

96 h

Hardness:

250 mg CaCO3/L

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

> 100 mg/L

Validity criteria fulfilled:

yes

Conclusions:

In conclusion after 96 hours, the test item showed no toxicity (NOEC) to fish <100 mg/L.

Executive summary:

The test item showed no toxicity to fish (96 hour NOEC) at <100 mg/L. The acute toxicity of the test item to fish was determined in the IBACON study following OECD guideline 203. Only a summary of the study is available.

Description of key information

The LC50 values are > 100 mg/L for dilthium azelate and for reaction mixture of hydrogenated tallow alkyl amines with sebacic acid and calcium hydroxide.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

No data on acute toxicity to fish is available for the substance, reaction mass of amines, hydrogenated tallow alkyl and azelaic acid and lithium hydroxide. Therefore, the endpoint is completed with data on dilithium azelate and on reaction product of hydrogenated tallow alkyl amines with sebacic acid and calcium hydroxide.

Two key studies conducted with read across substances, dilithium azelate and reaction mixture of hydrogenated tallow alkyl amines with sebacic acid and calcium hydroxide are available for this endpoint. No effects on the fish mortality were observed in both studies, therefore it was concluded that the LC50 values are > 100 mg/L for dilthium azelate and for reaction mixture of hydrogenated tallow alkyl amines with sebacic acid and calcium hydroxide.

 

The studies were conducted according to o an OECD 203 guideline and EC method C1 and are GLP-compliant, therefore are considered reliable and suitable for this endpoint.