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Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16.10.1990-18.10.1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
MONITORING OF TEST SUBSTANCE CONCENTRATION:
Analytical monitoring at the beginning and the end of test.
Vehicle:
no
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: waterflea (Daphnia magna)
- Source: RCC own breeding
- Age at study initiation (mean and range, SD): <24 h
- Method of breeding: Breeding was performed in about 10 L glass vessels in mixtures of pond and reconstituted water with slight aeration. They were fed with algae and kept under the same temperature and light conditions as used in the test itself.
- Feeding during test: no

ACCLIMATION
- Acclimation period: not necessary
- Acclimation conditions (same as test or not): yes
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Test temperature:
20.0 - 20.5 °C
pH:
8.3 - 8.4 (start), 8.2 - 8.4 (end)
Dissolved oxygen:
8.0 - 8.1 mg/L (start), 7.9 - 8.3 mg/L (end)
Nominal and measured concentrations:
Concentrations:
6.25; 12.5; 25; 50; 100 mg product/L (nominal)
1.9, 3.75, 7.5, 15, 30 mg active substance/L (nominal)
Details on test conditions:
TEST SYSTEM
- Test vessel: 50 mL beaker
- Material, size, headspace, fill volume: glass/50 mL/-/20 mL
- Aeration: not reported
- Type of flow-through (e.g. peristaltic or proportional diluter): test performed under static conditions
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water prepared acc. to EEC Directive
- Culture medium different from test medium: no
- Intervals of water quality measurement: pH and oxygen were measured at the beginning and at the end of the test

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h illumination
- Light intensity: 500-2000 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobilization

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study: performed (test conditions/concentrations not specified in this report)
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
6.5 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Remarks on result:
other: 95% C.I.: 4.8 - 8.4 mg a.i./L
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 30 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Details on results:
RESULTS: EXPOSED
- Nominal/measured concentrations: nominal
48h-EC0: 5.3 mg product/L
48h-EC50: 21.5 mg product/L
48h-EC100: 89.3 mg product/L

Assuming a content of 30% active substance:
48h-EC0: ca. 1.6 mg active substance/L
48h-EC50: ca. 6.5 mg active substance/L
48h-EC100: ca. 26.8 mg active substance/L
Reported statistics and error estimates:
The 48 h EC50 was estimated using the Logit-model and EC0, EC50, and EC100 values were determined by linear regression of values used for the Logit estimation.
The acute toxicity of C8 -18 AAPB to Daphnia magna was investigated in a study conducted according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) and EU Method C.2 (Acute Toxicity for Daphnia). The results were compiled in the following table. Table 1: Effect of TEGO Betain on immobilisation of Daphnia magna

Treatment (mg a.i./l)
[nominal conc. ]

No. of organ-isms at test begin

Observation period

24 h

48 h

Cumul. no. of dead

% morta-lity

Cumul. no. of dead

% morta-lity

Control (dilution water only)

Replicate #1

 10

 0

 0

 0

 0

Replicate #2

 10

 0

 0

 0

 0

1.9

Replicate #1

 10

 0

 0

 1

 10

Replicate #2

 10

 0

 0

 0

 0

3.75

Replicate #1

 10

 0

 0

 3

 30

Replicate #2

 10

 0

 0

 1

 10

7.5

Replicate #1

 10

 4

 40

 7

 70

Replicate #2

 10

 1

 10

8

 80

15

Replicate #1

10

1

10

8

80

Replicate #2

10

3

30

7

70

30

Replicate #1

 10

 4

 40

 10

 100

Replicate #2

 10

 5

 50

 10

 100

48h-EC0: 5.3 mg product/L

48h-EC50: 21.5 mg product/L

48h-EC100: 89.3 mg product/L

Assuming a content of 30% active substance:

48h-EC0: ca. 1.6 mg active substance/L

48h-EC50: ca. 6.5 mg active substance/L

48h-EC100: ca. 26.8 mg active substance/L

Validity criteria fulfilled:
yes
Conclusions:
The 48 h EC50 of C8-18 AAPB to Daphnia magna was determined to be 6.5 mg a.i./L nominal in a study conducted according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) and EU Method C.2 (Acute Toxicity for Daphnia).
Executive summary:

The 48 hr-acute toxicity of C8 -18 AAPB (30% active matter) to Daphnia magna was investigated in a study conducted according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) and EU Method C.2 (Acute Toxicity for Daphnia) under static conditions. Daphnids were exposed to control and test chemical at nominal concentrations of 6.25; 12.5; 25; 50; 100 mg product/L for 48 hr. The test material concentrations were analysed via UV absorption at 485 nm. The C8 -18 AAPB concentrations were >80% (exception: 72.2% at the start in the 6.25 mg product/L group). The 48 h EC50 was determined to be 6.5 mg a.i./L.

This study is classified as reliable without restriction.

Results Synopsis
Test Organism/Age (e.g. 1st instar): Daphnia magna/<24h
Test Type: Static
48 h EC50:  6.5 mg a.i./L;
95% C.I.: 4.8 to 8.4 mg a.i./L nominal
Endpoint(s) Effected:  Immobilization

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
see "General Justification for Read-Across" attached to IUCLID section 13

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Mutual read across from the AAPBs to one another is justified:

a) Based on the information given in section 1, it can be concluded that all AAPBs mentioned above are similar in structure, since they are manufactured from similar resp. identical precursors under similar conditions and all contain the same functional groups. Thus a common mode of action can be assumed.
b) The content of minor constituents in all products are comparable and differ to an irrelevant amount.
c) The only deviation within this group of substances is a minor variety in their fatty acid moiety, which is not expected to have a relevant impact on intrinsic toxic or ecotoxic activity and environmental fate. Potential minor impact on specific endpoints will be discussed in the specific endpoint sections.

The read-across hypothesis is based on structural similarity of target and source substances. Based on the available experimental data, including key physico-chemical properties and data from toxicokinetic, acute toxicity, irritation, sensitisation, genotoxicity and repeated dose toxicity studies, the read-across strategy is supported by a quite similar toxicological profile of all five substances.
The respective data are summarised in the data matrix; robust study summaries are included in the Technical Dossier in the respective sections.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
see "General Justification for Read-Across" attached to IUCLID section 13

3. ANALOGUE APPROACH JUSTIFICATION
see "General Justification for Read-Across" attached to IUCLID section 13

4. DATA MATRIX
see "General Justification for Read-Across" attached to IUCLID section 13
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across: supporting information
Key result
Duration:
48 h
Dose descriptor:
EC50
Remarks:
freshwater invertebrates
Effect conc.:
ca. 1.9 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Remarks on result:
other: 95% CL: 1.37 - 2.69 mg a.i./L
Key result
Duration:
48 h
Dose descriptor:
LC50
Remarks:
marine invertebrates
Effect conc.:
7 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: 95% c.i.: 5.4 - 8.3 mg a.i./L
Conclusions:
For freshwater invertebrates (Daphnia magna) the lowest 48 h EC50 was determined to be 1.9 mg a. i./L (nominal), and for the marine copepod Acartia tonsa  the 48 h EC50 was 7.0 mg a.i./L (nominal).

Description of key information

The acute toxicity of Coco AAPB to Daphnia magna was investigated in four studies conducted according to OECD guideline 202. The study with the lowest 48 h EC50 was selected as key study. Additional data were available for C8-18 AAPB from an OECD 202 guideline study with Daphnia magna. The acute toxicity of Coco AAPB to the marine copepod Acartia tonsa was investigated in a study conducted according to ISO 14669 (1999) Water 
Quality - Determination of the acute lethal toxicity to marine capepods (Copepoda; Crustacea).

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
1.9 mg/L
EC50/LC50 for marine water invertebrates:
7 mg/L

Additional information

Reliable results on the acute toxicity of C8-18 AAPB and the closely related source substance C8-18 and C18 unsatd. AAPB to fresh water invertebrates obtained in guideline studies are available, as well as data on the acute toxicity of C8-18 and C18 unsatd. AAPB to salt water invertebrates.

A justification for read-across is given below.

 

Freshwater invertebrates

The acute toxicity of Coco AAPB to Daphnia magna was investigated in a study conducted according to OECD TG 202 / part I (1984) under static conditions. Daphnia magna was exposed to 6 nominal concentrations ranging from 0.5 to 16 mg product/L. A 48 h LC50 of ca. 1.9 mg a.i/L (nominal) was determined based on an active matter content of 30%.

 

The 48 hr-acute toxicity of C8-18 AAPB (30% active matter) to Daphnia magna was investigated in a study conducted according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) and EU Method C.2 (Acute Toxicity for Daphnia) under static conditions. Daphnids were exposed to control and test chemical at nominal concentrations of 6.25; 12.5; 25; 50; 100 mg product/L for 48 hr. The test material concentrations were analysed via UV absorption at 485 nm. The C8-18 AAPB concentrations were >80% (exception: 72.2% at the start in the 6.25 mg product/L group). The 48 h EC50 was determined to be 6.5 mg a.i./L based on nominal concentrations.

 

Two further supporting studies are available:

The acute toxicity of Coco AAPB to Daphnia magna was investigated in a study conducted according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) and EU Method C.2 (Acute Toxicity for Daphnia). The daphnids were exposed to nominal concentrations of 0 (control), 0.56, 1.0, 1.8, 3.2, 5.6, and 10.0 mg a.i./L for 48 h under semi-static conditions (renewal of the test solutions after 24 h). The 48 h EC50 was found to be 4.1 mg a.i./L (nominal).

 

The 48-hr-acute toxicity of Coco AAPB to Daphnia magna was investigated in a study conducted according to EU Method C.2 (Acute Toxicity for Daphnia) under static conditions. Daphnids were exposed to control and test chemical at (nominal/measured) concentration of 3.5; 6; 10; 17; 30 mg dry residue/L for 48 hr. Immobilization were observed. The 48 h EC50 was 6.6 mg a.i./L nominal.

 

Marine invertebrates

The acute toxicity of Coco AAPB to the marine copepod Acartia tonsa was investigated in a study conducted according to ISO 14669 (1999) Water Quality - Determination of the acute lethal toxicity to marine capepods (Copepoda; Crustacea). Acartia tonsa were exposed to nominal Coco AAPB static conditions for 48 h. The 48 h NOEC and LC50 values were determined to be 3.6 mg a. i./L and 7.0 mg a.i./L nominal, respectively. The 48 h LC50 of 7.0 mg a i./L nominal was used for further assessment.

 

Conclusion

For freshwater invertebrates (Daphnia magna) the lowest 48 h EC50 was determined to be 1.9 mg a. i./L (nominal), and for the marine copepod Acartia tonsa  the 48 h EC50 was 7.0 mg a.i./L (nominal).

 

Justification for read-across

For details on substance identity and detailed (eco)toxicological profiles, please refer also to the general justification for read-across given at the beginning of the CSR and attached as pdf document to IUCLID section 13.

 

This read-across approach is justified based on structural similarities. All AAPBs contain the same functional groups. Thus a common mode of action can be assumed.

The only deviation within this group of substances is a minor variety in their fatty acid moiety (chain length and degree of unsaturation), which is not expected to have a relevant impact on intrinsic ecotoxicological properties.

 

a. Structural similarity and functional groups

Alkylamidopropyl betaines (AAPBs) are – with the exception of C12 AAPB - UVCB substances (Substances of Unknown or Variable composition, Complex reaction products or Biological materials), which are defined as reaction products of natural fatty acids or oils with dimethylaminopropylamine and further reaction with sodium monochloroacetate. AAPBs are amphoteric surfactants, which are characterized by both acidic and alkaline properties.

 

Their general structure is:

 

R-C(O)-NH-(CH2)3-(N(CH3)2)+-CH2-C(O)O-

R = fatty acid moiety

 

The fatty acids have a mixed, slightly varying composition with an even numbered chain length from C8 to C18. Unsaturated C18 may be included. Consequently, the AAPBs differ by their carbon chain length distribution and the degree of unsaturation in the fatty acid moiety. However, Lauramidopropyl betaine (C12 fatty acid derivate) is the major ingredient of all AAPBs covered by this justification as listed in table 1 “Substance identities” of the general justification for read-across.

 

The substances under evaluation share structural similarities with common functional groups (quaternary amines, amide bonds and carboxymethyl groups), and fatty acid chains with differences in chain length and degree of saturation.

 

b. Differences

Differences in acute ecotoxicity of the AAPBs could potentially arise from the following facts:

-Different amounts of different carbon chain lengths (carbon chain length distribution):

Higher amounts of higher chain lengths and corresponding lower amounts of lower chain length could result in a rising average lipophilicity. However, the main component for all AAPBs is C12 AAPB. Relevant effects on ecotoxicity are not to be expected.

- Different amounts of unsaturated fatty ester moieties:

Effects may be expected for e.g. physical state, but are not considered to be of relevance for ecotoxicity.

 

Comparison of short-term invertebrate toxicity data

 

Endpoints

Source substance

Target substance

 

C8-18 and C18 unsatd. AAPB

C8-18 AAPB

Short-term toxicity to aquatic invertebrates

key.Short-term toxicity to aquatic invertebrates: 61789-40-0_9.1.1_KAO Corporation_1992_OECD 202

 

key study

 

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) (part I, 24h EC50 Acute Immobilization Test (1984))


Daphnia magna, static, freshwater

 

48 h EC50 ca. 1.9 mg/Lact. ingr. (nominal) based on: mobility (95% CL: 1.37 - 2.69 mg a.i./L)

 

Reliability: 2 (reliable with restrictions), GLP

 

key_Short-term toxicity to aquatic invertebrates: 97862-59-4_9.1.1_THG_1991c_OECD 202

 

key study

 

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Daphnia magna, static, freshwater

 

48 h EC50 = 6.5 mg/Lact. ingr. (nominal) based on: mobility (95% C.I.: 4.8 - 8.4 mg a.i./L)


24 h EC50 > 30 mg/L
act. ingr. (nominal) based on: mobility

 

Reliability: 1 (reliable without restriction), GLP

 

 

key (marine).Short-term toxicity to aquatic invertebrates.61789-40-0_9.1.1__Marine_48h_AcartiaTonsa_Rhodia_Mirataine-BET-C37_ISO_2008

 

key study

 

ISO 14669 (1999) Water Quality - Determination of the acute lethal toxicity to marine copepods (Copepoda; Crustacea)


Acartia tonsa, static,
saltwater


48 h NOEC = 10 mg/L
test mat. (nominal) based on: mobility (95% c.i.: 14.85-23.01 mg/L)


48 h NOEC = 3.6 mg/L
act. ingr. (nominal) based on: mobility (95% c.i.: 5.4 - 8.3 mg a.i./L)

 

48 h LC50 = 19.38 mg/Ltest mat. (nominal) based on: mobility (95% c.i.: 14.85-23.01 mg/L)


48 h LC50 = 7 mg/L
 act. ingr. (nominal) based on: mobility (95% c.i.: 5.4 - 8.3 mg a.i./L)

 

Reliability: 1 (reliable without restriction), GLP

 

sup.Short-term toxicity to aquatic invertebrates.61789-40-0_9.1.1_Acute_Daphnia_Unilever_A17-AT-L17-01

supporting study


OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

 

Daphnia magna, semi-static, freshwater

 
48 h EC50 = 4.1 mg/L
act. ingr. (nominal) based on: mobility (95% c.i.: 3.3-5.3 mg a.i./L)

 

Reliability: 2 (reliable with restrictions), GLP

 

sup.Short-term toxicity to aquatic invertebrates: 61789-40-0_9.1.1_Hüls_1996_EEC 92-69 C2

 

supporting study

 

EU Method C.2 (Acute Toxicity for Daphnia)


Daphnia magna, static, freshwater

 

48 h EC0 < 3 mg/Lact. ingr. (nominal) based on: mobility
48 h EC100 > 25 mg/L
act. ingr. (nominal) based on: mobility
48 h EC50 = 6.6 mg/L
act. ingr. (nominal) based on: mobility (95% c.i. 4 - 11 mg/L)

 

Reliability: 2 (reliable with restrictions), GLP

 

The 48 h EC50 values of C8-18 AAPB and C8-18, C18 unsatd. AAPB to Daphnia magna were in the range of 1.9 – 6.6 mg a.i./L. The sensitivity of the marine invertebrate Acartia tonsa was in the same order of magnitude (48 h EC50 = 7 mg a.i./L)

 

Quality of the experimental data of the analogues:

The available data are adequate and sufficiently reliable to justify the read-across approach.

The studies with Daphnia magna were conducted according to OECD Guideline 202 or EU Method C.2 and were reliable or reliable with restrictions (RL1-2, GLP).

A further study with the saltwater organism Acartia tonsa was conducted according to ISO 14669 (RL1, GLP)

The test materials used in the respective studies represent the source substance as described in the hypothesis in terms of substance identity and minor constituents.

Overall, the study results are adequate for the purpose of classification and labelling and risk assessment.

 

Conclusion

Based on structural similarities of the target and source substancesas presented above and in more detail in the general justification for read across, it can be concluded that the available data from the source substance C8-18 and C18 unsatd. AAPB are also valid for the target substance C8-18 AAPB.

 

For freshwater invertebrates (Daphnia magna) the lowest 48 h EC50 was determined to be 1.9 mg a. i./L (nominal), and for the marine copepod Acartia tonsa the 48 h EC50 was 7.0 mg a.i./L (nominal).