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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Justification for type of information:
Due to insufficient reporting of the experimental details, this study was rated with a Klimisch score of 4 (‘not assignable’). As none of the available studies can serve as a key study with a sufficiently detailed reporting justifying a Klimisch score of 1 or 2 for the given endpoint, several independent sources were used in a weight of evidence approach. ‘Using weight of evidence implies that no single study of sufficient quality and reliability exists, and that information from several independent sources is required to be able to reach a conclusion on a particular property of the substance.’ (guidance document How to prepare registration and PPORD dossiers, p. 87)
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
Version: 1984
Deviations:
no
GLP compliance:
not specified
Specific details on test material used for the study:
- Analytical purity: not specified
Analytical monitoring:
yes
Test organisms (species):
Daphnia magna
Test type:
semi-static
Water media type:
freshwater
Remarks:
tap water filtrated by activated carbon (pH7.4~7.9, Ca/Mg=3.5~4.l, Na/K=5.5~6.4, hardness 20~32)
Total exposure duration:
48 h
Test temperature:
20 ± 1 °C
pH:
7.4-7.9
Dissolved oxygen:
8-9 ppm
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
14.27 mg/L
Remarks on result:
other: ± 2.07 (CV=14.5)
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
9.74 mg/L
Remarks on result:
other: ± 1.20 (CV=12.3)
Details on results:
CV= coefficient of variation
It is not clearly indicated in the results table, whether the reported results for 3-nitrotoluene were obtained with or without surfactant.
Validity criteria fulfilled:
not specified
Executive summary:

Kodoma, 2003


The toxicity of 3-nitrotoluene to the aquatic invertebrate Daphnia magna was evaluated in a 48 h study performed in accordance with OECD TG 202 (1984). The 48h-EC50 value was determined to be 9.74 mg/L and the 48h-LC50 value was reported as 14.27 mg/L. It is not clearly indicated in the results table, whether the reported results for 3-nitrotoluene were obtained with or without surfactant.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
Basic data given. Restrictions of the method are: - Test period only 4 instead of 48h (represents only 8% of the in the OECD and other current guidelines suggested test period)-Temperature during the test was higher (25 °C) than the one suggested by OECD and other current guidelines (22 °C) - Yeast is not a standard food for Daphnia
Justification for type of information:
Due to methodological deficiencies, this study was rated with a Klimisch score of 3 (‘not reliable’). As none of the available studies can serve as a key study with a sufficiently detailed reporting justifying a Klimisch score of 1 or 2 for the given endpoint, several independent sources were used in a weight of evidence approach. ‘Using weight of evidence implies that no single study of sufficient quality and reliability exists, and that information from several independent sources is required to be able to reach a conclusion on a particular property of the substance.’ (guidance document How to prepare registration and PPORD dossiers, p. 87). Despite being considered not  reliable (Klimisch 3), the experimental value obtained in this study still supports the WoE conclusion confirming that the EC50 is in the order of magnitude of the concluded key value.
Principles of method if other than guideline:
not specified
GLP compliance:
not specified
Specific details on test material used for the study:
purity more than 98%, purchased from E. Merck, Darmstadt, Germany.
Test organisms (species):
Daphnia pulex
Details on test organisms:
Daphnia (Daphnia pulex) was obtained from Plant Toxicology Department, Taiwan Agricultural Chemicals and Toxic Substances Research Institute, Taichung, Taiwan.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
4 h
Test temperature:
25 ± 1°C
pH:
6.6
Dissolved oxygen:
4.9 mgL/L
Salinity:
hardness 215 mg/L as CaCO3
Details on test conditions:
Daphnia were fed with yeast in a 224 (diameter) x 46 (height)-cm circular plastic pool. Before the experiment, the test organisms were acclimatized in aquaria for 2 weeks under conditions similar to those under which the tests were performed.

Twenty daphnia, within 24 hr after hatching, were introduced in each 250-mL beaker containing 100 mL of test chemical solution with different concentrations. Adequate
concentrations of 2-nitrotoluene were prepared individually in duplicate for each test chemical. Mortality of daphnia was observed after an incubation period of 4 h. If the appropriate concentration for mortality was beyond the test range, the experiment was carried out once more with a more appropriate concentration.
Duration:
4 h
Dose descriptor:
LC50
Effect conc.:
84.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Validity criteria fulfilled:
not specified
Remarks:
Restrictions of the method: - Test period only 4 instead of 48h -Temperature during the test was higher (25 °C) than 22 °C - Yeast is not a standard food for Daphnia
Executive summary:

Yen, 2002: In a short-term toxicity test on Daphnia pulex an LC50 value of 0.845 mg/l after a 4-h exposure period was obtained for 3-nitrotoluene. After request, one of the authors (Wang 2003) communicated that the reported values are below the observed values by a factor of 100. Thus, the correct LC50 is 84.5 mg/l. Despite being considered not  reliable (Klimisch 3, Restrictions of the method: - Test period only 4 instead of 48h -Temperature during the test was higher (25 °C) than 22 °C - Yeast is not a standard food for Daphnia), the experimental value obtained in this study still supports the WoE conclusion confirming that the EC50 is in the order of magnitude of the concluded key value. 

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Test procedure according to national standards.
Justification for type of information:
Due to insufficient reporting of the experimental details, this study was rated with a Klimisch score of 4 (‘not assignable’). As none of the available studies can serve as a key study with a sufficiently detailed reporting justifying a Klimisch score of 1 or 2 for the given endpoint, several independent sources were used in a weight of evidence approach. ‘Using weight of evidence implies that no single study of sufficient quality and reliability exists, and that information from several independent sources is required to be able to reach a conclusion on a particular property of the substance.’ (guidance document How to prepare registration and PPORD dossiers, p. 87)
Principles of method if other than guideline:
Method by US-EPA 1975 (EPA-660/3-75-009)
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (as cited in study report): 3-Nitrotoluene
- Analytical purity: no data; unknown source
Analytical monitoring:
yes
Details on test solutions:
- Stock solution: The stock solution was prepared by dissolving a measured amount of chemical in a known volume of water.
No carrier was used. The mixing time was about 24 h. The stock solution was filtered through a 5 µm filter and analyzed for the chemical.
Test organisms (species):
Daphnia magna
Details on test organisms:
The invertebrate species were from stocks reared in the laboratory at SRI International where the study was performed.
No food provided during the test.
Test type:
static
Water media type:
freshwater
Total exposure duration:
48 h
Hardness:
33.8 ± 19 mg/L as CaCO3
Test temperature:
20°C
pH:
7.7 ± 0.35
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
28.1 mg/L
Remarks on result:
other: 25.3-31.6
Executive summary:

Liu, 1983


The toxicity of 3-nitrotoluene to the aquatic invertebrate Daphnia magna was evaluated in a 48 h study performed in accordance with US-EPA method 1975 (EPA-660/3-75-009). The 48h-EC50 (mobility) was determined to be 28.1 mg/L.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Test procedure in accordance with national standard methods, with acceptable restrictions
Justification for type of information:
Due to insufficient reporting of the experimental details, this study was rated with a Klimisch score of 4 (‘not assignable’). As none of the available studies can serve as a key study with a sufficiently detailed reporting justifying a Klimisch score of 1 or 2 for the given endpoint, several independent sources were used in a weight of evidence approach. ‘Using weight of evidence implies that no single study of sufficient quality and reliability exists, and that information from several independent sources is required to be able to reach a conclusion on a particular property of the substance.' (guidance document How to prepare registration and PPORD dossiers, p. 87)
Principles of method if other than guideline:
Protocol of the Dutch Standards Organisation NEN 6501
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (as cited in study report): 3-nitrotoluene
- Analytical purity: > 98%
Analytical monitoring:
not specified
Details on test solutions:
synthetic test medium (NPR 6503, 1980)
Test organisms (species):
Daphnia magna
Details on test organisms:
< 24 h old
Test type:
static
Water media type:
freshwater
Total exposure duration:
48 h
Hardness:
200 mg/L as CaCO3
Test temperature:
20 ± 0.5
pH:
8.4 ± 0.1
Dissolved oxygen:
not less than 7.9 mg/L
Duration:
48 h
Dose descriptor:
IC50
Effect conc.:
7.5 mg/L
Details on results:
Results expressed as Log IC50=1.74 to show 48-h IC50 in µmol/l to the waterflea, Daphnia magna
Executive summary:

Deneer et al., (1989) performed a 48-h immobilisation test for D. magna in static test conditions, according to the protocol of the Dutch Standards Organization, NEN 6501 (1980). During the tests, daphnids were fed with Chlorella pyrenidosa, which at the start of the experiments was present at a concentration of 1·108 cells/l. All daphnids used were <24 hours old at the beginning of the experiments. A 48h-LC50 of 7.5 mg/l was determined. 

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Justification for type of information:
Due to insufficient reporting of the experimental details, this study was rated with a Klimisch score of 4 (‘not assignable’). As none of the available studies can serve as a key study with a sufficiently detailed reporting justifying a Klimisch score of 1 or 2 for the given endpoint, several independent sources were used in a weight of evidence approach. ‘Using weight of evidence implies that no single study of sufficient quality and reliability exists, and that information from several independent sources is required to be able to reach a conclusion on a particular property of the substance.' (guidance document How to prepare registration and PPORD dossiers, p. 87)
Qualifier:
equivalent or similar to guideline
Guideline:
other: OECD proposal (1979)
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (as cited in study report): 3-Nitrotoluene
- Analytical purity: > 99.5 %
Analytical monitoring:
yes
Test organisms (species):
Daphnia magna
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Details on test conditions:
closed system due to stability (see details on analytical methods).
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
17.6 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
7.4 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mobility
Executive summary:

Canton et al. 1985


The toxicity of 3-nitrotoluene to the aquatic invertebrate Daphnia magna was evaluated in a 48 h study performed in accordance with the OECD proposal (1979). The 48h-EC50 (mobility) was determined to be 7.4 mg/L and the 48h-LC50 was determined to be 17.6 mg/L.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Method not validated; test conducted for 24 hs.
Justification for type of information:
Due to methodological deficiencies, this study was rated with a Klimisch score of 3 (‘not reliable’). As none of the available studies can serve as a key study with a sufficiently detailed reporting justifying a Klimisch score of 1 or 2 for the given endpoint, several independent sources were used in a weight of evidence approach. ‘Using weight of evidence implies that no single study of sufficient quality and reliability exists, and that information from several independent sources is required to be able to reach a conclusion on a particular property of the substance.’ (guidance document How to prepare registration and PPORD dossiers, p. 87). Despite being considered not  reliable (Klimisch 3), the experimental value obtained in this study still supports the WoE conclusion confirming that the EC50 is in the order of magnitude of the concluded key value.
Principles of method if other than guideline:
24-hour immobilization test; static method
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (as cited in study report): 3-nitrotoluene
- Analytical purity: > 95%
Analytical monitoring:
no
Test organisms (species):
Daphnia magna
Details on test organisms:
- Daphnids were cultured parthenogenetically in an environmental chamber at 22 ± 1 °C
- Photoperiod of 14 hours daylight, 10 hours darkness
- Daphnids were fed with a diet of green algae
- 6 to 24 hours old daphnids were used for toxicity test
Test type:
static
Water media type:
freshwater
Total exposure duration:
24 h
Test temperature:
22 ± 1 °C
Details on test conditions:
- 5 replicates for every concentration
- Results were considered valid, when oxygen concentration was > 60 % of saturation, and if immobilization in controls was zero at the end of experiment
- Endpoint: immobilization
Duration:
24 h
Dose descriptor:
IC50
Effect conc.:
20.8 mg/L
Basis for effect:
mobility
Remarks on result:
other: observed value

Measured result was reported to be log 1/IC50 = 3.82, calculated result was reported to be log 1/IC50 = 3.98.

Validity criteria fulfilled:
yes
Remarks:
- Results were considered valid, when oxygen concentration was > 60 % of saturation, and if immobilization in controls was zero at the end of experiment
Executive summary:

Zhao, 1995


The toxicity of 3-nitrotoluene to the aquatic invertebrate Daphnia magna was evaluated in a 24 h static test. The 24h-IC50 (mobility) was determined to be 20.8 mg/L. This result has been included as additional information. Despite being considered not  reliable (Klimisch 3, the exposure time was too short: 24 h instead of the required 48h), the experimental value obtained in this study still supports the WoE conclusion confirming that the EC50 is in the order of magnitude of the concluded key value.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Method not validated; test conducted for 24 hs
Justification for type of information:
Due to methodological deficiencies, this study was rated with a Klimisch score of 3 (‘not reliable’). As none of the available studies can serve as a key study with a sufficiently detailed reporting justifying a Klimisch score of 1 or 2 for the given endpoint, several independent sources were used in a weight of evidence approach. ‘Using weight of evidence implies that no single study of sufficient quality and reliability exists, and that information from several independent sources is required to be able to reach a conclusion on a particular property of the substance.’ (guidance document How to prepare registration and PPORD dossiers, p. 87). Despite being considered not  reliable (Klimisch 3), the experimental value obtained in this study still supports the WoE conclusion confirming that the EC50 is in the order of magnitude of the concluded key value.
Principles of method if other than guideline:
other: 24-h immobilization test according to Bringmann G and Kuehn R
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): 3-Nitrotoluol
- Analytical purity: no data
Analytical monitoring:
no
Test organisms (species):
Daphnia magna
Test type:
static
Water media type:
freshwater
Total exposure duration:
24 h
Hardness:
corresponding to 286 mg/l CaCO3
Test temperature:
20-22 °C
pH:
7.6-7.7
Reference substance (positive control):
yes
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
24 mg/L
Duration:
24 h
Dose descriptor:
EC0
Effect conc.:
13 mg/L
Duration:
24 h
Dose descriptor:
EC100
Effect conc.:
51 mg/L

- Effect endpoint: immobilization
- Effect values refer to nominal test substance concentrations

Validity criteria fulfilled:
not specified
Executive summary:

Bringmann and Kühn (1982) carried out an acute short test on Daphnia magna. The effects of 3-nitrotoluene were measured on 24-h individuals after 24-h exposure period. Following results are provided: an EC0 of 13 mg/l, an EC50 of 24 mg/l and an EC100 of 51 mg/l. This result has been included as additional information. Despite being considered not  reliable (Klimisch 3, the exposure time was too short: 24 h instead of the required 48h), the experimental value obtained in this study still supports the WoE conclusion confirming that the EC50 is in the order of magnitude of the concluded key value.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Method not validated; test conducted for 24 hs
Justification for type of information:
Due to methodological deficiencies, this study was rated with a Klimisch score of 3 (‘not reliable’). As none of the available studies can serve as a key study with a sufficiently detailed reporting justifying a Klimisch score of 1 or 2 for the given endpoint, several independent sources were used in a weight of evidence approach. ‘Using weight of evidence implies that no single study of sufficient quality and reliability exists, and that information from several independent sources is required to be able to reach a conclusion on a particular property of the substance.’ (guidance document How to prepare registration and PPORD dossiers, p. 87). Despite being considered not  reliable (Klimisch 3), the experimental value obtained in this study still supports the WoE conclusion confirming that the EC50 is in the order of magnitude of the concluded key value.
Principles of method if other than guideline:
other: 24 h-immobilization test according to Bringmann G and Kuehn R
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): 3-Nitrotoluol
- Analytical purity: no data
Analytical monitoring:
no
Test organisms (species):
Daphnia magna
Test type:
static
Water media type:
freshwater
Total exposure duration:
24 h
Hardness:
corresponding to 286 mg/l CaCO3
Test temperature:
20-22 °C
pH:
7.6-7.7
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
35 mg/L
Duration:
24 h
Dose descriptor:
LC0
Effect conc.:
11 mg/L
Duration:
24 h
Dose descriptor:
LC100
Effect conc.:
88 mg/L

- Effect endpoint: immobilization
- Effect values refer to nominal test substance concentrations

Validity criteria fulfilled:
not specified
Executive summary:

Bringmann and Kühn (1977) carried out an acute short test on Daphnia magna. The effects of 3-nitrotoluene were measured on 24-h individuals after 24-h exposure period. Following results are provided: an LC0 of 11 mg/l, an LC50 of 35 mg/l and an LC100 of 88 mg/l. This result has been included as additional information. Despite being considered not  reliable (Klimisch 3, the exposure time was too short: 24 h instead of the required 48h), the experimental value obtained in this study still supports the WoE conclusion confirming that the EC50 is in the order of magnitude of the concluded key value.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Justification for type of information:
Due to insufficient reporting of the experimental details, this study was rated with a Klimisch score of 4 (‘not assignable’). As none of the available studies can serve as a key study with a sufficiently detailed reporting justifying a Klimisch score of 1 or 2 for the given endpoint, several independent sources were used in a weight of evidence approach. ‘Using weight of evidence implies that no single study of sufficient quality and reliability exists, and that information from several independent sources is required to be able to reach a conclusion on a particular property of the substance.' (guidance document How to prepare registration and PPORD dossiers, p. 87)
Principles of method if other than guideline:
NEN 6501: Determination of acute toxicity with Daphnia magna (1980) with slight modifications (Van Leeuwen et al. 1985).
48 h-LC50 value and the 95 % confidence interval were calculated according to Litchfield JT and Wilcoxon F (1949).
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (as cited in study report): 3-nitrotoluene
- Analytical purity: > 98 %
- Molecular weight: 137.14
Analytical monitoring:
not specified
Test organisms (species):
Daphnia magna
Details on test organisms:
For each concentration, 10 daphnids were used, one animal per jar containing 50 ml medium.
The daphnids were fed on 1x10E+8 cells/L unicellular green algae (C. pyrenidosa).
Test type:
static
Water media type:
freshwater
Total exposure duration:
48 h
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
7.5 mg/L
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL; (5.6-10)
Executive summary:

Maas-Diepeveen and van Leeuwen, 1986


A test on the acute toxicity of 3-nitrotoluene to the invertebrate Daphnia magna was performed according to the Dutch Standardization Organization Method NEN 6501. For a test period of 48 hours an LC50 value of 7.5 mg/l was reported.

Description of key information

In order to fulfill the data requirements a weight of evidence (WoE) approach (REACh Regulation (EC) No. 1907/2006, Annex XI Section 1.2) was chosen. This approach is a possible adaptation to the standard information requirements which ‘should be undertaken to maximise the use of existing data and minimise the commissioning of new in vivo testing’ (ECHA Guidance R.7a, 2017, p. 364). The WoE approach serves to reduce or avoid animal testing, which should only be performed as last resort (REACh, article 25). The individual study reports were conducted in accordance with standardized guidelines. The study reports nevertheless show some deficiencies with respect to the comprehensiveness of the presented experimental details. Therefore, a reliability of 1 or 2 and thus adequacy as key study was not assignable for any of the individual studies. Consequently, the studies were assigned a Klimisch score of 4 (according to guidance document R.4, ‘not assignable: studies or data […] which do not give sufficient experimental details […]). Collectively, these experimental studies can be used to conclude on this endpoint and to satisfy the information requirement.


Maas-Diepeveen and van Leeuwen, 1986


A test on the acute toxicity of 3-nitrotoluene to the invertebrate Daphnia magna was performed according to the Dutch Standardization Organization Method NEN 6501. For a test period of 48 hours an LC50 value of 7.5 mg/l was reported.


Canton et al. 1985


The toxicity of 3-nitrotoluene to the aquatic invertebrate Daphnia magna was evaluated in a 48 h study performed in accordance with the OECD proposal (1979). The 48h-EC50 (mobility) was determined to be 7.4 mg/L and the 48h-LC50 was determined to be 17.6 mg/L.


Deneer et al., (1989) performed a 48-h immobilisation test for D. magna in static test conditions, according to the protocol of the Dutch Standards Organization, NEN 6501 (1980). During the tests, daphnids were fed with Chlorella pyrenidosa, which at the start of the experiments was present at a concentration of 1·108 cells/l. All daphnids used were <24 hours old at the beginning of the experiments. A 48h-EC50 (immobilization) of 7.5 mg/l was determined. 


Liu, 1983


The toxicity of 3-nitrotoluene to the aquatic invertebrate Daphnia magna was evaluated in a 48 h study performed in accordance with US-EPA method 1975 (EPA-660/3-75-009). The 48h-EC50 (mobility) was determined to be 28.1 mg/L.


Yen, 2002


In a short-term toxicity test on Daphnia pulex an LC50 value of 0.845 mg/l after a 4-h exposure period was obtained for 3-nitrotoluene. After request, one of the authors (Wang 2003) communicated that the reported values are below the observed values by a factor of 100. Thus, the correct LC50 is 84.5 mg/l. Despite being considered not  reliable (Klimisch 3, Restrictions of the method: - Test period only 4 instead of 48h -Temperature during the test was higher (25 °C) than 22 °C - Yeast is not a standard food for Daphnia), the experimental value obtained in this study still supports the WoE conclusion confirming that the EC50 is in the order of magnitude of the concluded key value. 


Kodoma, 2003


The toxicity of 3-nitrotoluene to the aquatic invertebrate Daphnia magna was evaluated in a 48 h study performed in accordance with OECD TG 202 (1984). The 48h-EC50 value was determined to be 9.74 mg/L and the 48h-LC50 value was reported as 14.27 mg/L. It is not clearly indicated in the results table, whether the reported results for 3-nitrotoluene were obtained with or without surfactant.


The results obtained by Zhao et al. (1995) and those obtained by Bringmann et al.  (1982, 1977) were  included in the WoE approach despite being considered not reliable (Klimisch 3) due to methodological deficiencies. The reported 24-h EC50 values are in the same order of magnitude. 


Zhao, 1995


The toxicity of 3-nitrotoluene to the aquatic invertebrate Daphnia magna was evaluated in a 24 h static test. The 24h-IC50 (mobility) was determined to be 20.8 mg/L. This result has been included as additional information. Despite being considered not  reliable (Klimisch 3, the exposure time was too short: 24 h instead of the required 48h), the experimental value obtained in this study still supports the WoE conclusion confirming that the EC50 is in the order of magnitude of the concluded key value.


Bringmann and Kühn (1982) carried out an acute short test on Daphnia magna. The effects of 3-nitrotoluene were measured on 24-h individuals after 24-h exposure period. Following results are provided: an EC0 of 13 mg/l, an EC50 of 24 mg/l and an EC100 of 51 mg/l. This result has been included as additional information. Despite being considered not  reliable (Klimisch 3, the exposure time was too short: 24 h instead of the required 48h), the experimental value obtained in this study still supports the WoE conclusion confirming that the EC50 is in the order of magnitude of the concluded key value.


Bringmann and Kühn (1977) carried out an acute short test on Daphnia magna. The effects of 3-nitrotoluene were measured on 24-h individuals after 24-h exposure period. Following results are provided: an LC0 of 11 mg/l, an LC50 of 35 mg/l and an LC100 of 88 mg/l. This result has been included as additional information. Despite being considered not  reliable (Klimisch 3, the exposure time was too short: 24 h instead of the required 48h), the experimental value obtained in this study still supports the WoE conclusion confirming that the EC50 is in the order of magnitude of the concluded key value.


 


Conclusion
The EC50 and LC50 values obtained from these studies are in a similar order of magnitude.


48h-EC50: 7.4 mg/l - 28.1 mg/L
48h-LC50: 7.5 mg/l - 17.6 mg/L
24h-EC50: 20.8 - 24 mg/L
24h-LC50: 35 mg/l


The most conservative 48h-LC50 value of 7.5 mg/L  (Deneer 1989, Maas-Diepeveen 1986) is chosen as key value for assessment.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
LC50
Effect concentration:
7.5 mg/L

Additional information