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Short-term toxicity to fish

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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:
other: Experimental determination according to national guideline, no information about GLP
Qualifier:
according to guideline
Guideline:
other: ISRA (Rome, 1973): Saggio di tossicita con animali acquatici
Principles of method if other than guideline:
Test with rainbow trout Salmo gairdneri to establish the 96h LC50 (lethal concentration for 50 % of the animals at 96 h).
Additionally, seven days soft water acclimated rainbow trout were tested in water having a 20 mg CaCo3/L hardness instead of 320 mg CaCO3/L.
GLP compliance:
not specified
Analytical monitoring:
not specified
Vehicle:
no
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Test type:
not specified
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96
Hardness:
320 mg CaCO3/L (a) - hard water test
20 mg CaCO3/L (b) - soft water test
Test temperature:
15 °C
pH:
7.4
Dissolved oxygen:
more than 95 % saturation
Reference substance (positive control):
not specified
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
118 mg/L
Nominal / measured:
not specified
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Remarks on result:
other: hard water test (320 mg CaCO3/L)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
17 mg/L
Nominal / measured:
not specified
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Remarks on result:
other: soft water test (20 mg CaCO3/L)
Details on results:
Toxicity increased with decreasing total hardness of water.
Validity criteria fulfilled:
yes
Conclusions:
LC50 (96 h) = 118 mg/L (hard water test, 320 mg CaCO3/L)
LC50 (96h) = 17 mg/L (soft water test, 20 mg CaCO3/L)
Executive summary:

Calamari D. et.al. performed an experiment to test the acute toxicity of dimethylamine (and other amines) to rainbow trout Salmo gairdneri (new name: Oncorhynchus mykiss) in 1980. This test establish the 96 h LC50 (lethal concentration for 50 % of the animals at 96 h) in hard water (320 mg CaCO3/L) as well as in soft water (20 mg CaCO3/L). The experimental guideline according "ISRA (Rome, 1973): Saggio di tossicita con animali acquatici" was used. As results LC50 (96h) of 118 mg/L and LC50 (96h) of 17 mg/L were reported for hard water and soft water conditions, respectively.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
96 hours
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions.
Qualifier:
no guideline available
Guideline:
other: Microscopic observation of embryo development
Principles of method if other than guideline:
Development of zebrafish eggs was observed microscopically for 96 hours beginning with the 8 cell stage. Twelve eggs were used in the control group and for each test concentration group.
GLP compliance:
not specified
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
The test substance was dissolved in reconstituted water
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Eggs were obtained as follows:
- Four female and eight male mature zebrafish were kept together overnight for spawning at dawn simulated by neon lighting.
- The eggs were fertilized extracorporally by the delivered sperm of the males.
- The spawn was collected on the bottom of a glass box covered by a steel wire net; the eggs were separated and cultured at 25 deg C individually using micro plates containing 100 uL reconstituted water.
Test type:
not specified
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
- The eggs were observed microscopically for approx. 96 hours until hatching for mortality and abnormal signs in development.
- Development stages were determined according to Hisaoka and Battle (1958).
Hardness:
200 mg/L as CaCO3
Test temperature:
25 °C
pH:
adjusted to pH 8 by HCl
Details on test conditions:
Exposure:
- At the 8 cell stage 100 µL of test substance in reconstituted water were added
- A concentration range from 2 - 500 mM was tested, additionally, untreated eggs were used as controls
- Twelve eggs per test concentration were tested

- Development was studied microscopically until hatching after about 96 hours
- Marked signs of development were recorded
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
other: NOEL
Effect conc.:
45.08 mg/L
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
396.7 mg/L
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
4 508 mg/L
Details on results:
- No deaths or morphological changes were observed in the controls
- N-methylamine did not induce any malformations and hatched embryos developed normally
Reported statistics and error estimates:
- Embryo lethality was calculated based on the method of Litchfield and Wilcoxon from 1949
- A t-test, asymptotic normal distribution test, was used for statistical comparisons of differences
Validity criteria fulfilled:
yes
Conclusions:
LC50 = 396.7 mg/L
The results obtained in fish embroys may have a predictive value for the assessment of possible hazards of chemicals in wildlife and humans.
Executive summary:

LC50 = 396.7 mg/L

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given (no information given on test conditions, i.e. temperature, pH, dissolved oxygen)
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
not specified
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material: No surrogate or analogue material was used.
Analytical monitoring:
not specified
Details on sampling:
No details available.
Vehicle:
no
Details on test solutions:
No details available.
Test organisms (species):
Poecilia reticulata
Details on test organisms:
No further details available.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
No post exposure observation period.
Hardness:
No details available.
Test temperature:
No details available.
pH:
No details available.
Dissolved oxygen:
No details available.
Salinity:
No details available.
Nominal and measured concentrations:
No details available.
Details on test conditions:
- semi-static: renewal of test solutions every 24 h
Reference substance (positive control):
not specified
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
210 mg/L
Nominal / measured:
not specified
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95 % CL: 127 to 349 mg/L
Details on results:
No further details available.
Results with reference substance (positive control):
Not applicable.
Reported statistics and error estimates:
Effect values and their 95 % confidence intervals were calculated according to the Litchfield and Wilcoxon (1949) method.
Validity criteria fulfilled:
not specified
Remarks:
Basic data given.
Conclusions:
Basic data given. Concerning the obtained value (LC50(96h): 210 mg/L) the substance is not toxic to fish.
Executive summary:

The acute toxicity of the test substance towards Pecilia reticulata was investigated according to OECD Guideline 203 (Van Leeuwen et al., 1985). Only basic data are reported, no detailled description of the test conditions. A semi-static mode was conducted whereby the test solutions were renewed every 24 hours. As result, a LC50(96h) value of 210 mg/L ist reported.

Description of key information

LC50(96h): 118 mg/L (result of the key study, Salmo gairdneri, Calamari et al., 1980),
LC50(96h): 396.70 mg/L, LC100(96h): 4508 mg/L, NOEL(96h): 45.08 mg/L (Brachydanio rerio, Groth et al., 1993),
LC50(96h): 210 mg/L (Poecilia reticulata, Van Leeuwen et al., 1985),

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
118 mg/L

Additional information

Calamari et al. (1980) performed an experiment to test the acute toxicity of dimethylamine (and other amines) to rainbow trout Salmo gairdneri (new name: Oncorhynchus mykiss). This test establishes LC50(96h) values (meaning the lethal concentration for 50 % of the animals at 96 h) in hard water (320 mg CaCO3/L) as well as in soft water (20 mg CaCO3/L). The experimental guideline according "ISRA (Rome, 1973): Saggio di tossicita con animali acquatici" was used. As results LC50 (96h) of 118 mg/L and LC50 (96h) of 17 mg/L were reported for hard water and soft water conditions, respectively.

Additionally, the acute toxicity to fish of dimethylamine was investigated by Groth et al. (1993). Development of Brachydanio rerio (new name: Danio rerio) eggs was observed microscopically for 96 hours beginning with the 8 cell stage. The following results were obtained: LC50: 396.7 mg/L, LC100: 4508 mg/L and NOEL: 45.08 mg/L. 

Furthermore, the acute toxicity towards Pecilia reticulata was investigated according to OECD Guideline 203 (Van Leeuwen et al., 1985). Only basic data are reported, no detailed description of the test conditions. A semi-static mode was conducted whereby the test solutions were renewed every 24 hours. As result, a LC50(96h) value of 210 mg/L is reported.