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Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
18-04-1990 till 18-05-1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The test was performed in three separate tests with different fish batches. The LC50 is however determined in the last of the three tests in which also the LC0 and LC100 was determined. No quantification of the exposure concentration by chemical analyses. No purity/impurity data of the test substance is available
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
(1984)
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
(1984)
Principles of method if other than guideline:
The test was performed in three steps
First: 1 mg/L and control were tested
Second: 0.1 mg/L and control were tested
Third: 0.22, 0.5 and control were tested
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
The test substance was brought into test water and homogenized using ultra-Turrax and a sonicationbath. The test solutions were homogenized in the test vessels during 2 hours. Test concentrations: 0, 0.1, 0.22, 0.5 and 1 mg/L
At 0.22 and 0. 5 mg/L inhomogenity was observed as deposits at the water surface and bottom of the test vessels. This was not observed at the other test concentrations.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Barchydanio rerio
- Strain: (Hamilton-Buchanan)
- Source: West Aquarium 3422 Bad Lauterberg
- Age at study initiation (mean and range, SD):
Hatching date: 19.10.89/ 01.02.90/07.02.90
Date of receival: 09.01.90/24.04.09/03.05.90
- Length at study initiation (length definition, mean, range and SD):
Batch 1/90/L2 23.04.90 n=10 range: 2.9 - 3.4 average: 3.2 S = 0.16
Batch 4/90/L2 07.05.90 n=10 range: 2.4 - 2.9 average: 2.7 S = 0.18
Batch 5/90/L3 14.05.90 n=10 range: 2.7 - 3.4 average: 3.0 S = 0.24

ACCLIMATION
- Acclimation period: 14 days, 10 days for batch 5/90/L3
- Acclimation conditions (same as test or not): 22 deg C
- Type and amount of food: Tetramin twice a day ad libitum
- Health during acclimation (any mortality observed): No remarkable observations

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Remarks on exposure duration:
in reconstitued lab wate
Hardness:
according to ISO/DIS 7346/1
Test temperature:
21.2 - 22.5 deg C
pH:
7.6 - 8.3
Dissolved oxygen:
7.1 - 9.2 mg/L
Salinity:
according to ISO/DIS 7346/1
Nominal and measured concentrations:
test concentrations: 0, 0.1, 0.22, 0.5 and 1 mg/L (nominal)
Details on test conditions:
Glass aquaria of L/B/H of 30/22/24 cm with a volume of 10 L. Thermostrated at 22 deg C. 12 hours light/12 hours darkness about 700 Lux. Without aeration. Dilution water according to ISO/DIS 7346/1 pH 8.1 - 8.3
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
0.1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.148 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
0.22 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
At 0.1 and 0.5 mg/L sublethal effects were observed like: reduced activity, change in appearance and breathing rate.
At 1 mg/L none of these effects could be observed because the fish died before the first evaluation moment.
Fish that had died appeared shiny metallic,
Results with reference substance (positive control):
-
Reported statistics and error estimates:
LC50 is determined as geometrical mean between LC0 and LC100 in the absence of partial effects.
Sublethal observations / clinical signs:

48 h       96 h

0        0/30      0/30

0.1      0/10      0/10

0.22     10/10     10/10         

0.5       10/10     10/10

1        10/10     10/10

Validity criteria fulfilled:
no
Remarks:
There is no evidence demonstrating that the test substance concentration has been maintained
Conclusions:
The validity is of the test is hampered by the absence of purity data and the absence of evidence demonstrating that the test substance concentration has been maintained during the test. Despite the fact that the test substance is most likely stable during the test the observation that deposits have been observed at the LC0 and LC100 test concentrations which makes the LC50 less reliable.
The information presented in the report is sufficient and transparent which should allow a repetition of the test
It is not expected that a repetition of the test will lead to significantly different results
Executive summary:

The short -term (96 h) toxicity of Genamin SHP 100 (CAS no: 68603 -64 -5) to Danio rerio was observed to be 0.148 mg/L (LC50 96 h). The test substance is poorly water soluble and therefore mechanical equipment was used to prepare the test solutions. No chemical analyses was performed in the absence of suitable analytical techniques, which means that the effect data are based on nominal concentrations.

Description of key information

No toxicity tests with fish have been performed with "Reaction mass of Amines, N-tallow alkyltrimethylenedi-, (2-ethylhexanoates), Amines, N-tallow alkyltrimethylenedi-, acetates and n-tallow-1,3 -diaminopropane ditallate" (R814M). This substance is the salt of tallow-1,3 -diaminopropane (CAS no 1219010 -04 -4) and a mixture of talloil fatty acids, 2 -ethylhexoic and acetic acid.

Under aquatic environmental conditions a large extend of the salt is expected to be dissociated and ecotoxicity observed will originate mainly from tallow-1,3 -diaminopropane. No effects (NOEL>=100 mg/L) were observed for the WAF of tall oil fatty acid to algae and daphnids and for 2 -ethyl hexanoic acid the lowest NOEC (21d daphnia) was 25 mg/L (ECHA) . Therefore available ecotoxicity data on alkyl-1,3-diamines were included in the dataset. The ecotoxicity of tallow-1,3 -diaminopropane is expected to be reduced when forming a salt with talloil fatty acids or 2 -ethylhexoic acid but as a worst-case the available ecotoxicity data of tallow-1,3 -diaminopropane (CAS no 1219010 -04 -4) will be used as a worst-case. The results of tallow-1,3 -diaminopropane will be recalculated to R814M using the tallow-1,3 -diaminopropane of 52.2% in R814M.

 

For alkyl-1,3 -diaminopropanes, seven acute toxicity tests with fish are available for various alkyl-1,3 -diaminopropanes with C12 -18 chains (all reliability 2) which were used for read across to tallow-1,3 diamino propane. The available fish tests reveal a comparable toxicity for the diamines with alkyl chain lengths ranging from C12 to C18, independent of the alkyl chain length.

The acute fish tests with the alkyl-1,3 -diaminopropanes were considered to be valid with restrictions for various reasons. The test concentrations were not analytically verified because a reliable specific method of analysis was not available at the time when the tests were performed. Further concerns are related to the poor solubility of the test substances and partial sorption onto the walls of test vessels.

The available acute fish toxicity data with alkyl-1,3 -diaminopropanes are all determined with the same species, endpoint, test duration, life stage and testing conditions and they have the same reliability rating. As the results are not more than order of magnitude apart (96h LC50 range 0.08 - 0.35 mg/L), they were harmonised by a geometric mean according to REACH Guidance document Chapter R.7b.

The geometric mean LC50 for all 7 alkyl-1,3 -diaminopropane fish tests has been calculated to be 0.150 mg/L.

For one of the salts of R814M, i.e. tallow-1,3 -diaminopropane acetate there is acute fish test available (AkzoNobel 1990b, CAS no 61791 -54 -6). This study is of a similar quality as the other alkyl-1,3 -diaminopropane studies. The observed 96h LC50 of 0.150 mg/L of the acetate salt of tallow-1,3 -diaminopropane is exactly the same as the geometric mean derived for the alkyl-1,3 -diaminopropanes. Considering the comparable quality of the studies and similar test results the geometric mean of 0.150 mg/L as calculated for the alkyl-1,3 -diaminopropanes is used for R814M.

R814M consists for 52.2% out of Tallow-1,3 -diaminopropane and because the amine fraction is considered to be the toxic fraction the geometric mean of 0.150 mg/L should be corrected to 0.287 mg/L

There is also an acute fish study available with oleyl-1,3 -diaminopropane oleate (AkzoNobel 2012, CAS no 34140 -91 -5; 96h LC50 = 1.3 mg/L) which can be considered to be a comparable substance to the talloil fatty acid salt of tallow-1,3 -diaminopropane. This study has however been performed with natural river water and is therefore difficult to compare with the other available acute fish test study results. This study result however indicates that a significantly lower toxicity to fish may be expected for the tallow-1,3 -diaminopropane tallate when it is tested in natural river water.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
0.287 mg/L

Additional information

For alkyl-1,3 -diaminopropanes, seven acute toxicity tests with fish are available for various alkyl-1,3 -diaminopropanes with C12 -18 chains (all reliability 2) which were used for read across to tallow-1,3 diamino propane. The available fish tests reveal a comparable toxicity for the diamines with alkyl chain lengths ranging from C12 to C18, independent of the alkyl chain lenght.

The acute fish tests with the alkyl-1,3 -diaminopropanes were considered to be valid with restrictions for various reasons. The test concentrations were not analytically verified because a reliable specific method of analysis was not available at the time when the test was performed. Further concerns related to the poor solubility of the test substances and partial sorption onto the walls of test vessels.

The available acute fish toxicity data with alkyl-1,3 -diaminopropanes are all determined with the same species, endpoint, test duration, life stage and testing conditions and they have te same reliability rating. As the results are not more than order of magnitude apart (96h LC50 range 0.08 - 0.35 mg/L), they were harmonised by a geometric mean according to REACH Guidance document Chapter R.7b.

The geometric mean of all 7 tests with alkyl-1,3 -diaminopropanes has been calculated resulting in LC50 of 0.150 mg/L. Based on a comparison of the available acute fish, daphnia and algae data, it can be concluded that fish are less sensitive to the alkyl-1,3 -diamines than daphnia and algae using the geometric mean of all available acute test data. It can therefore be concluded that the fish toxicity will not be a critical endpoint for the PNEC derivation, Classification and PBT assessment.

Acute toxicity to fish of alkyl-1,3 -diaminopropanes

CAS no

Species/test

Result

Reference

Remarks

90640-43-0

Danio rerio

0.1<96h-LC50 < 0.35 mg/L

Clariant 1985

Reliability 2, GLP

68603-64-5 (old)

133779 -11 -0 (new)

Danio rerio

96h-LC50 = 0.148 mg/L

Clariant 1990

Reliability 2,

GLP

7173-62-8

Danio rerio

96h-LC50 = 0.32 mg/L

Clariant 1991

Reliability 2,

GLP

7173-62-8

Danio rerio

96h-LC50 = 0.16 mg/L

CECA 1997

 

Reliability 2,

GLP

61791-55 -7 (old)

1219010 -04 -4 (new)

Danio rerio

96h-LC50 = 0.1 mg/L

Akzo Nobel 1990

Reliability 2,

GLP

61791 -63 -7 (old)

68155-37-3 (new)

Danio rerio

96h-LC50 = 0.08 mg/L

Akzo Nobel 1993

Reliability 2,

GLP

61791-63-7 (old) 

68155-37-3(new)

Danio rerio

96h-LC50 = 0.15 mg/L

Clariant 1990

Reliability 2, GLP