Registration Dossier
Registration Dossier
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EC number: 907-578-1 | CAS number: -
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is carried out in accordance to OECD guideline 202 and is GLP compliant.
- 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 source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation 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.2 (Acute Toxicity for Daphnia)
- 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.
- Principles of method if other than guideline:
- Combined limit/range finding study.
- 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 48 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:
- Nominal concentrations: 0.10, 1.0, 10 and 100 mg/L
Medium: 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 with vigorous shaking. The lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium.
Appearance: The final test solutions were all clear and colourless. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Source: Daphnia magna (Crustacea, Cladocera) (Straus, 1820), at least third generation, obtained by acyclical parthenogenesis under specified breeding conditions from an in-house laboratory culture with a known history.
Batch: Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress.
Age: Young daphnids with an age of < 24 hours, from parental daphnids of more than two weeks old. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Post exposure observation period:
- None
- Hardness:
- Not reported. Breeding water: 180 mg CaCO3/L
- Test temperature:
- 20-21°C
- pH:
- pH 7.8-8.0
- Dissolved oxygen:
- 8.9-9.0 mg/L
- Salinity:
- Not applicable
- Nominal and measured concentrations:
- Nominal concentrations: 0.1, 1, 10 and 100 mg/L.
The measured concentrations based on azelate were at the level of 91-93% of nominal during the exposure period.
The measured concentrations based on lithium were at the level of 99-101% of nominal during the exposure period.
The measured concentrations at 0h were 0.065 and 56 mg TOC/L and at 48h they were 0.17 and 55 mg TOC/L for the control and the highest concentration respectively. The TOC remained relatively stable throughout the test. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 mL
- Material, fill volume: Glass, 80 mL
- Aeration: No aeration of test solutions
- No. of organisms per vessel: 5
- No. of daphnids per concentration: 20 for control and limit concentration, 10 for lower concentrations
-Introduction of daphnids: Within 39 minutes of preparation of the test solutions
OTHER TEST CONDITIONS
- Photoperiod: 16 hours
- Feeding: No feeding - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate (K2Cr2O7)
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- The 48h-EC50 exceeded the nominal concentration of 100 mg/L.
- Results with reference substance (positive control):
- The actual responses in this reference test with K2Cr2O7 are within the ranges of the expected responses at the different concentrations, i.e. the 48h-EC50 was between 0.3 and 1.0 mg/L. Hence, the sensitivity of the Daphnia was within the range determined with the historical data collected at WIL Research Europe.
- Reported statistics and error estimates:
- Not reported.
- Validity criteria fulfilled:
- yes
- Conclusions:
- No EC50 could be calculated because the test substance did not cause a significant difference to the mobility of the Daphnia magna (EC50 > 100 mg/L, the maximum concentration tested).
- Executive summary:
The effect of dilithium azelate on the mobility of the Daphnia Magna was investigated according to an OECD 202 guideline and EC method C2. A 48 hour combined range finder / limit test was conducted at 0.1, 1, 10 and 100 mg/L under static conditions. At the start of the test all solutions were clear and colourless. Analysis of the fatty acid (azelate) was between 91 and 93% nominal and the lithium concentration was between 99 and 101% of nominal throughout the test. The total organic carbon (TOC) measured at the start of the test was 56 mg/L and at the end of the test was 55 mg/L for the highest test concentration. 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 effects on the mobility of Daphnia Magna were observed in the test the EC50 is > 100 mg/L dilthium azelate.
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is carried out in accordance to OECD guideline 202 and is GLP compliant.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation 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.2 (Acute Toxicity for Daphnia)
- 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.
- Principles of method if other than guideline:
- Combined limit/range finding study.
- 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 48 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:
- Nominal concentrations: 0.10, 1.0, 10 and 100 mg/L
Medium: 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 with vigorous shaking. The lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium.
Appearance: The final test solutions were all clear and colourless. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Source: Daphnia magna (Crustacea, Cladocera) (Straus, 1820), at least third generation, obtained by acyclical parthenogenesis under specified breeding conditions from an in-house laboratory culture with a known history.
Batch: Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress.
Age: Young daphnids with an age of < 24 hours, from parental daphnids of more than two weeks old. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Post exposure observation period:
- None
- Hardness:
- Not reported. Breeding water: 180 mg CaCO3/L
- Test temperature:
- 20-21°C
- pH:
- pH 7.8-8.0
- Dissolved oxygen:
- 8.9-9.0 mg/L
- Salinity:
- Not applicable
- Nominal and measured concentrations:
- Nominal concentrations: 0.1, 1, 10 and 100 mg/L.
The measured concentrations based on azelate were at the level of 91-93% of nominal during the exposure period.
The measured concentrations based on lithium were at the level of 99-101% of nominal during the exposure period.
The measured concentrations at 0h were 0.065 and 56 mg TOC/L and at 48h they were 0.17 and 55 mg TOC/L for the control and the highest concentration respectively. The TOC remained relatively stable throughout the test. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 mL
- Material, fill volume: Glass, 80 mL
- Aeration: No aeration of test solutions
- No. of organisms per vessel: 5
- No. of daphnids per concentration: 20 for control and limit concentration, 10 for lower concentrations
-Introduction of daphnids: Within 39 minutes of preparation of the test solutions
OTHER TEST CONDITIONS
- Photoperiod: 16 hours
- Feeding: No feeding - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate (K2Cr2O7)
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- The 48h-EC50 exceeded the nominal concentration of 100 mg/L.
- Results with reference substance (positive control):
- The actual responses in this reference test with K2Cr2O7 are within the ranges of the expected responses at the different concentrations, i.e. the 48h-EC50 was between 0.3 and 1.0 mg/L. Hence, the sensitivity of the Daphnia was within the range determined with the historical data collected at WIL Research Europe.
- Reported statistics and error estimates:
- Not reported.
- Validity criteria fulfilled:
- yes
- Conclusions:
- No EC50 could be calculated because the test substance did not cause a significant difference to the mobility of the Daphnia magna (EC50 > 100 mg/L, the maximum concentration tested).
- Executive summary:
The effect of dilithium azelate on the mobility of the Daphnia Magna was investigated according to an OECD 202 guideline and EC method C2. A 48 hour combined range finder / limit test was conducted at 0.1, 1, 10 and 100 mg/L under static conditions. At the start of the test all solutions were clear and colourless. Analysis of the fatty acid (azelate) was between 91 and 93% nominal and the lithium concentration was between 99 and 101% of nominal throughout the test. The total organic carbon (TOC) measured at the start of the test was 56 mg/L and at the end of the test was 55 mg/L for the highest test concentration. 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 effects on the mobility of Daphnia Magna were observed in the test the EC50 is > 100 mg/L dilthium azelate.
- Endpoint:
- short-term toxicity to aquatic invertebrates
- 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/EWG, C.2; OECD 202
- GLP compliance:
- yes
- Details on test solutions:
- Identity and concentration of auxiliary solvent for dispersal: Entfällt, da die Testsubstanz direkt im Testmedium gelöst wird.
"ENGLISH"
Not applicable because the test substance is directly dissolved in test medium. - Test organisms (species):
- other aquatic crustacea: DM
- Hardness:
- 250 mg CaCO3/L
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- > 100 mg/L
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- > 100 mg/L
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- 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 source
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, C.2; OECD 202
- GLP compliance:
- yes
- Details on test solutions:
- Identity and concentration of auxiliary solvent for dispersal: Entfällt, da die Testsubstanz direkt im Testmedium gelöst wird.
"ENGLISH"
Not applicable because the test substance is directly dissolved in test medium. - Test organisms (species):
- other aquatic crustacea: DM
- Hardness:
- 250 mg CaCO3/L
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- > 100 mg/L
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- > 100 mg/L
Referenceopen allclose all
Time (h) |
Replicate |
Nominal concentration Dilithium azelate (mg/L) |
||||
Control |
0.10 |
1.0 |
10 |
100 |
||
0 |
A |
5 |
5 |
5 |
5 |
5 |
B |
5 |
5 |
5 |
5 |
5 |
|
C |
5 |
|
|
|
5 |
|
D |
5 |
|
|
|
5 |
|
Total introduced |
20 |
10 |
10 |
10 |
20 |
|
24 |
A |
0 (1) |
0 |
0 |
0 |
0 |
B |
0 |
0 |
0 |
0 |
0 |
|
C |
0 |
|
|
|
0 |
|
D |
0 |
|
|
|
1 |
|
Total immobilised |
0 |
0 |
0 |
0 |
1 |
|
Effect % |
0 |
0 |
0 |
0 |
5 |
|
|
|
|
|
|
||
48 |
A |
0 |
0 |
0 |
0 |
0 |
B |
0 |
0 |
0 |
0 |
0 |
|
C |
1 |
|
|
|
0 |
|
D |
0 |
|
|
|
1 |
|
Total immobilised |
1 |
0 |
0 |
0 |
1 |
|
Effect % |
5 |
0 |
0 |
0 |
5 |
|
Parameter |
Nominal concentration Dilithium azelate (mg/L) |
24-48h-EC50 |
>100 |
Concentration K2Cr2O7 (mg/L) |
Number Exposed |
% immobile |
Expected response (%) After 48 hours1 |
|||
24h |
48h |
Minimal |
Maximal |
|||
control |
20 |
0 |
0 |
0 |
102 |
|
0.10 |
20 |
0 |
0 |
0 |
10 |
|
0.18 |
20 |
0 |
0 |
0 |
10 |
|
0.32 |
20 |
0 |
10 |
0 |
30 |
|
0.56 |
20 |
10 |
100 |
0 |
100 |
|
1.0 |
20 |
95 |
100 |
40 |
100 |
|
1.8 |
20 |
100 |
100 |
100 |
100 |
|
( ) between brackets: number of Daphnia observed trapped at the surface of the test solutions. This organism was reimmersed into the respective solution before recording of mobility.
1 – Based on historical data of the previous years (n>60).
2 – A maximum response of 10% does not invalidate the results of the test.
Time (h) |
Replicate |
Nominal concentration Dilithium azelate (mg/L) |
||||
Control |
0.10 |
1.0 |
10 |
100 |
||
0 |
A |
5 |
5 |
5 |
5 |
5 |
B |
5 |
5 |
5 |
5 |
5 |
|
C |
5 |
|
|
|
5 |
|
D |
5 |
|
|
|
5 |
|
Total introduced |
20 |
10 |
10 |
10 |
20 |
|
24 |
A |
0 (1) |
0 |
0 |
0 |
0 |
B |
0 |
0 |
0 |
0 |
0 |
|
C |
0 |
|
|
|
0 |
|
D |
0 |
|
|
|
1 |
|
Total immobilised |
0 |
0 |
0 |
0 |
1 |
|
Effect % |
0 |
0 |
0 |
0 |
5 |
|
|
|
|
|
|
||
48 |
A |
0 |
0 |
0 |
0 |
0 |
B |
0 |
0 |
0 |
0 |
0 |
|
C |
1 |
|
|
|
0 |
|
D |
0 |
|
|
|
1 |
|
Total immobilised |
1 |
0 |
0 |
0 |
1 |
|
Effect % |
5 |
0 |
0 |
0 |
5 |
|
Parameter |
Nominal concentration Dilithium azelate (mg/L) |
24-48h-EC50 |
>100 |
Concentration K2Cr2O7 (mg/L) |
Number Exposed |
% immobile |
Expected response (%) After 48 hours1 |
|||
24h |
48h |
Minimal |
Maximal |
|||
control |
20 |
0 |
0 |
0 |
102 |
|
0.10 |
20 |
0 |
0 |
0 |
10 |
|
0.18 |
20 |
0 |
0 |
0 |
10 |
|
0.32 |
20 |
0 |
10 |
0 |
30 |
|
0.56 |
20 |
10 |
100 |
0 |
100 |
|
1.0 |
20 |
95 |
100 |
40 |
100 |
|
1.8 |
20 |
100 |
100 |
100 |
100 |
|
( ) between brackets: number of Daphnia observed trapped at the surface of the test solutions. This organism was reimmersed into the respective solution before recording of mobility.
1 – Based on historical data of the previous years (n>60).
2 – A maximum response of 10% does not invalidate the results of the test.
Description of key information
For dilthium azelate and for reaction mixture of hydrogenated tallow alkyl amines with sebacic acid and calcium hydroxide the 48-h EC50 values are > 100 mg/L.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 100 mg/L
Additional information
No data is available for the substance reaction mass of amines, hydrogenated tallow alkyl and azelaic acid and lithium hydroxide. Read across from dilithium azelate and reaction mixture of hydrogenated tallow alkyl amines with sebacic acid and calcium hydroxide is used to complete the short term toxicity to aquatic invertebrates endpoint.
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 mobility of Daphnia magna were observed in both studies, therefore the 48-h EC50 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 202 guideline and EC method C2 and are GLP-compliant, therefore are considered reliable and suitable for this endpoint.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
