Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan 3 - 5, 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study similar to a guideline study
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Qualifier:
according to
Guideline:
other: Procter and Gamble Internal SOP for acute toxicity testing
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
no
Analytical monitoring:
not specified
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION- Method: Test material stock solutions were prepared by diluting the test substance in distilled water.- Evidence of undissolved material (e.g. precipitate, surface film, etc): none
Test organisms (species):
Ceriodaphnia dubia
Details on test organisms:
TEST ORGANISM- Common name: Ceriodaphnia dubia- Strain: Not available- Source: Virginia Polytechnic Institute and State University In-house breeding culture- Age at study initiation: <24 hours- Weight, Length at study initiation: Not available- Method of breeding: C. dubia were cultured in 50 mL glass beakers with 20 mL culture medium- Feeding during test: not fedACCLIMATION- Acclimation period: Not available- Acclimation conditions (same as test or not): Not available- Type and amount of food: trialgal diet containing equal portions of Chlamydomonas reinhardtii, Chlamydomonas vulgaris and Ankistrodesmus falcatu- Feeding frequency: Not available- Health during acclimation (any mortality observed): Not available
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
114 - 205 mg/L as CaCO3
Test temperature:
25C +/- 2
pH:
7.4 - 8.0
Dissolved oxygen:
6.4 - 7.5 mg/L
Nominal and measured concentrations:
The test concentrations were 0 (control), 0.38, 1.56, 4.88, 10.9, ~30, and 101 mg/L. The study report does not clearly state whether these are nominal or measured concentrations.
Details on test conditions:
TEST SYSTEM- Test vessel: Test chamber is an open 35 mL disposable polystyrene cup fitted with 120-µM Nitex mesh on opposite sides- Aeration: no- Type of flow-through: peristaltic- Renewal rate of test solution: 360 mL per hour- No. of organisms per vessel: 10- No. of vessels per concentration (replicates): 2- No. of vessels per control (replicates): 2- Biomass loading rate: 10 daphnids/35 mLTEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: reconstituted water as described by Lauth et al. (1990)- Culture medium different from test medium: no- Alkalinity: 76.3 - 80-7 mg/L as CaCO3- Conductivity: 306 - 576 µmhos/cm- Intervals of water quality measurement: at the beginning and the end of the testOTHER TEST CONDITIONS- Photoperiod: 16/8 light/dark photoperiod- Light intensity: 150-400 foot candlesEFFECT PARAMETERS MEASURED: Mortality was determined daily throughout the test period.TEST CONCENTRATIONS- Spacing factor for test concentrations: 2.2 to 4.1- Range finding study: no
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
5.55 mg/L
Nominal / measured:
not specified
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: 4.28 - 7.20 mg/L
Details on results:
- Mortality of control: 0%- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No- Effect concentrations exceeding solubility of substance in test medium: No
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
The LC50 and 95% fiducial limits were calculated by Spearman-Karber (Hamilton et al., 1977)
Validity criteria fulfilled:
not specified
Remarks:
The study report provides no details to support whether the validity criteria were met or not. We are sure the study was conducted appropriately and was in strict accordance with the protocol cited.
Conclusions:
The 48-hr LC50 of C12AS (dodecyl alkyl sulfate) to Ceriodaphnia dubia was 5.55 (4.28 - 7.20) mg/L. It is uncertain as to whether the LC50 is based on nominal or measured concentrations. In a 48-hr acute toxicity study, Ceriodaphnia dubia were exposed to C12-AS at a range of concentrations of 0 (control), 0.38 - 101 mg/L and included seven treatments. The 48-hr LC50 value based on mortality was 5.55 mg/L with 95% C.I. of 4.28 - 7.20 mg/L. It is uncertain as to whether the LC50 is based on nominal or measured concentrations. However, the analytical verification of the test substance concentration for the chronic tests also given in the publication by Dyer et al. (1997) clearly indicate that the nominal concentrations are adequately maintained using the specific flow-through method developed. Thus, the toxicity study is classified as reliable and acceptable for hazard assessment.
Executive summary:

In a 48-hr acute toxicity study, Ceriodaphnia dubia were exposed to C12-AS at a range of concentrations of 0 (control), 0.38 - 101 mg/L and included seven treatments. The 48-hr LC50 value based on mortality was 5.55 mg/L with 95% C.I. of 4.28 - 7.20 mg/L. It is uncertain as to whether the LC50 is based on nominal or measured concentrations. However, the analytical verification of the test substance concentration for the chronic tests also given in the publication by Dyer et al. (1997) clearly indicate that the nominal concentrations are adequately maintained using the specific flow-through method developed. Thus, the toxicity study is classified as reliable and acceptable for hazard assessment.

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:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Reason / purpose:
read-across source
Analytical monitoring:
not specified
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION- Method: Test material stock solutions were prepared by diluting surfactants in distilled water- Controls: in dilution water without test substance added.- Evidence of undissolved material (e.g. precipitate, surface film, etc): none
Test organisms (species):
Ceriodaphnia dubia
Details on test organisms:
TEST ORGANISM- Common name: Ceriodaphnia dubia- Source: Virginia Polytechnic Institute and State University In-house breeding culture- Age at study initiation: <24 hours- Method of breeding: C. dubia were cultured in 50 mL glass beakers with 20 mL culture medium- Feeding during test: not fedACCLIMATION- Type and amount of food: trialgal diet containing equal portions of Chlamydomonas reinhardtii, Chlamydomonas vulgaris and Ankistrodesmus falcatus.
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
Not applicable
Hardness:
Not available
Test temperature:
25 ºC +/- 2 ºC
pH:
Not available
Dissolved oxygen:
Not available
Salinity:
Not available
Nominal and measured concentrations:
The test concentrations were 0 (control), 0.38, 1.56, 4.88, 10.9, ~30, and 101 mg/L. The study report does not clearly state whether these are nominal or measured concentrations.
Details on test conditions:
TEST SYSTEM- Test vessel: - Type: open - Material: Test chamber is a 35 mL disposable polystyrene cup fitted with 120-µM Nitex mesh on opposite sides - Aeration: No (test was flow-through)- Type of flow-through: peristaltic- Renewal rate of test solution: 360 mL per hour- No. of organisms per vessel: 10- No. of vessels per concentration (replicates): 2- No. of vessels per control (replicates): 2- Biomass loading rate: 10 daphnids/35 mLTEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: Reconstituted water as described by Lauth et al. (1990)- Culture medium different from test medium: NoOTHER TEST CONDITIONS- Adjustment of pH: Not available- Photoperiod: 16/8 light/dark photoperiod- Light intensity: 150-400 foot candlesEFFECT PARAMETERS MEASURED: mortality was determined dailyTEST CONCENTRATIONS- Spacing factor for test concentrations: 2.2 to 4.1- Range finding study: no
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
5.55 mg/L
Nominal / measured:
not specified
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: 4.28 - 7.20
Details on results:
- Behavioural abnormalities: Not available- Mortality of control: 0%- Other adverse effects control: Not available- Abnormal responses: Not available- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No- Effect concentrations exceeding solubility of substance in test medium: No
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
The LC50 and 95% fiducial limits were calculated by Spearman-Karber (Hamilton et al., 1977)
Validity criteria fulfilled:
not specified
Remarks:
The study report provides no details to support whether the validity criteria were met or not. We believe the study was conducted appropriately and was in strict accordance with the protocol cited.
Conclusions:
The 48-h LC50 of C12AS (dodecyl alkyl sulfate) to Ceriodaphnia dubia was 5.55 (4.28 – 7.20) mg/L. It is uncertain as to whether the LC50 is based on nominal or measured concentrations.
Executive summary:

In a 48-h acute toxicity study, Ceriodaphnia dubia were exposed to C12-AS at a range of concentrations of 0 (control), 0.38 - 101 mg/L and included seven exposures. The 48-h LC50 value based on mortality was 5.55 mg/L with 95% C.I. of 4.28 - 7.20 mg/L. It is uncertain as to whether the LC50 is based on nominal or measured concentrations. This toxicity study is classified as acceptable.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions.
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Principles of method if other than guideline:
Method: other: AFNOR T.90301 (1974), no further information
GLP compliance:
no
Analytical monitoring:
no
Test organisms (species):
Daphnia magna
Details on test organisms:
Daphnia magna Straus
Water media type:
freshwater
Total exposure duration:
24 h
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
800 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
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:
other: National guideline study with acceptable restrictions.
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Principles of method if other than guideline:
Method: other: Norme Francaise Homologue, 1983, NF T90-31, no further information
GLP compliance:
no
Analytical monitoring:
no
Details on test solutions:
Distilled water solution of the surfactant was used.
Test organisms (species):
Daphnia magna
Water media type:
freshwater
Total exposure duration:
24 h
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
470 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles. Peer reviewed data during the ICCA HPV program
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Static mortality test on Artemia nauplii using 6 concentrations of test substance in culture dishes
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION- Method: A 10 g/L stock solution is prepared by dissolving 1 g in 100 mL of artificial seawater. Amounts of this stock solution was diluted to give certain desired test concentrations.
Test organisms (species):
Artemia salina
Test type:
static
Water media type:
saltwater
Limit test:
no
Total exposure duration:
48 h
Test temperature:
20 °C
pH:
8.0
Salinity:
34.5 ‰
Nominal and measured concentrations:
Nominal: 1, 1.8, 3.2, 5.6, 10 and 18 mg/L
Details on test conditions:
TEST SYSTEM- Test vessel: 2Carolina culture dishes containing 100 mL test solutionTEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: synthetic seawater - Culture medium different from test medium: no- Intervals of water quality measurement: not specifiedOTHER TEST CONDITIONS- Adjustment of pH: yes EFFECT PARAMETERS MEASURED: Mortality was recorded after 48h test duration.
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
3.15 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Validity criteria fulfilled:
not applicable
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Reason / purpose:
read-across source
Analytical monitoring:
no
Test organisms (species):
Daphnia magna
Details on test organisms:
Daphnia magna Straus
Water media type:
freshwater
Total exposure duration:
24 h
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
800 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Reason / purpose:
read-across source
Analytical monitoring:
no
Details on test solutions:
Distilled water solution of the surfactant was used.
Test organisms (species):
Daphnia magna
Water media type:
freshwater
Total exposure duration:
24 h
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
470 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Reason / purpose:
read-across source
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Artemia salina
Test type:
static
Water media type:
saltwater
Limit test:
no
Total exposure duration:
48 h
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
3.15 - 3.8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

Description of key information

48h EC50 (Daphnia magna) >= 5.5 mg/L (freshwater, nominal concentration)
48h LC50 (Artemia salina) >= 3.15 mg/L (marine water, nominal concentration)

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
5.5 mg/L
EC50/LC50 for marine water invertebrates:
3.15 mg/L

Additional information

Since no reliable short-term test involving aquatic invertebrates is available for C9-12AS Na, in accordance to Regulation (EC) 1907/2006 Annex XI, 1.5, a read-across to other structurally related category members was conducted. Read-across data from C10AS Na (CAS 142-87-0) and C12AS Na (CAS 151-21-3) were used, since toxicity of alkyl sulfates is dependent on carbon chain length.

Two short-term studies with aquatic invertebrates are available for C12AS Na (CAS 151-21-3). In a key, non-GLP test Ceriodaphnia dubia was exposed to six test concentrations of C12AS Na (CAS 151-21-3) up to 101 mg/L (Lauth, 1996). The test was performed under flow-through conditions, no special guideline was followed. Mortality of daphnids was evaluated daily; the EC50 value determined after 48 hours of exposure was 5.55 mg/L.

Furthermore, a non-GLP study with CAS 151-21-3 using a common marine species (Artemia salina) is available (Zillioux, 1973). In this static test mortality of Artemia was determined in culture dishes using six concentrations of test substance up to 18 mg/L (nominal concentrations). The LC50 value after 48 hours of exposure ranged between 3.15 and 3.8 mg/L (nominal concentration).

Moreover, two 24-hour tests with Daphnia magna are available for C10AS Na (CAS 142-87-0). The first non-GLP study was performed following an AFNOR T.90301 (1974) method (Lundahl and Cabridenc, 1978). The obtained results showed that the 24-hour EC50 value was 800 mg/L (nominal concentrations). Analytical measurements are not available.

The other non-GLP study with Daphnia magna followed a method described by Norme Francaise Homologue, 1983, NF T90-31 (Sanchez Leal, 1991). The 24-hour EC50 value was 470 mg/L. Analytical check of the test concentrations was not provided.

Due to structural and property similarities with the tested category member, it can be concluded that the above result applies also to C9-12AS Na . The 48-hour EC50 value to the aquatic invertebrates is assumed to be 5.5 mg/L for freshwater invertebrates and 3.15 mg/L for marine invertebrates.