Propanoic acid, 2-hydroxy-, ammonium salt (1:1), (2S)-

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

fish early-life stage toxicity

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Justification for type of information:

For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Duration:

20 d

Dose descriptor:

EC10

Effect conc.:

ca. 2.19 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

other: total ammonia nitrogen (TAN)

Basis for effect:

reproduction

Details on results:

All three concentrations of ammonia tested in this study significantly reduced fecundity after 20 days of exposure (Dunnett's test, p ≤ 0.05 for each treatment). The lowest un-ionized ammonia concentration (0.06 mg/L at a pH of 7.3 and temperature of 25.1 °C) tested during this study resulted in a 29 % decrease in cumulative fecundity. Because all tested ammonia concentrations caused an effect on P. promelas reproduction, the no effect concentration was estimated to be 0.025 mg/L un-ionized ammonia (2.19 mg/L total ammonia–nitrogen). This estimate was determined using the U.S. EPA Toxicity Relationship Analysis Program to calculate the 10% effect concentration of ammonia on P. promelas reproduction.

Conclusions:

The NOEC was estimated to be 0.025 mg/L un-ionized ammonia (2.19 mg/L total ammonia–nitrogen).

Executive summary:

The 20-day chronic toxicity of ammonium chloride to early life stage of Pimephales promelas was studied under flow through conditions. 168 six-month old Pimpephales promelas were exposed to control, solvent control, and test chemical of three ammonia concentrations. The test system was maintained at 25 °C. The 20-day NOEC value, based on reproduction, was 2.19 mg/L (total ammonia nitrogen, TAN). There was a significant difference in cumulative egg production among treatments (ANOVA; F = 10.167, p ≤ 0.01, df = 3). All three concentrations of ammonia tested in this study significantly reduced fecundity after 20 days of exposure (Dunnett's test, p ≤ 0.05 for each treatment). The lowest test concentration (4.33 mg/L TAN at a pH of 7.3 and temperature of 25.1 °C) tested during this study resulted in a 29 % decrease in cumulative fecundity.

The methodology of this study is similar to OECD test guideline no. 229. Results can therefore be regarded as reliable.

Results synopsis

Test organism size/age: Males: 3.5 ± 0.5 g, females: 1.0 ± 0.5 g, 6 months old

Test type: flow-through

NOEC: 2.19 mg/L (TAN); 16.75 mg/L (ammonium lactate)

Endpoint(s) effected: Reproduction

This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reference 2

Endpoint:

fish early-life stage toxicity

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Justification for type of information:

For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Duration:

28 d

Dose descriptor:

NOEC

Remarks:

Pimephales promelas

Effect conc.:

ca. 11.8 mg/L

Nominal / measured:

meas. (not specified)

Duration:

28 d

Dose descriptor:

LOEC

Remarks:

Pimephales promelas

Effect conc.:

ca. 18.7 mg/L

Nominal / measured:

meas. (not specified)

Details on results:

Embryo survival showed no concentration-related effects, with hatching success ranging from 97.5 to 100 %. There was a significant (alpha = 0.05) decrease in the number of normal larvae at hatch at the 18.7 mg NH4Cl/L level and higher abnormalities such as small, poorly developed larvae and scoliosis were the most frequently observed effects. Larval survival showed a concentration-related response, with a significant (alpha = 0.05) decrease at 18.7 mg NH4Cl/L and higher. There was no significant (alpha = 0.05) decrease in growth at any of the concentrations tested; however, there was a significant increase in weight at the 11.8 mg NH4Cl/L level and higher. The increase in weight may be attributed to smaller numbers of fish at the higher concentrations, which reduced crowding effects and also resulted in more food on individual fish. The MATC, which was based on survival and percent normal larvae at hatch, was between 11.8 and 18.7 mg NH4Cl/L, and was 15.3 mg NH4Cl/L when expressed at the geometric mean of the high and low chronic values. Ranges for dissolved oxygen concentrations, pH and room temperature recorded during the test were 5.0-8.5 mg/L, 7.75-8.42, 23.7-25.8 °C, respectively.

Table 1: Results of fathead minnow embryo-larval toxicity test with ammonia.

Ammonia conc. [mg NH3-N/L]	% hatched	% normal at hatch	% survival at 28 d	Weight [mg]	Length [mm]
Control	100	98.3± 1.9	75± 3.3	45.9± 5.1	14.4± 0.6
0.10± 0.03	99.2± 1.7	98.3± 2.0	68.1± 4.0	52.7± 3.2	14.4± 0.5
0.17± 0.03	97.5± 1.7	100± 0.0	65.9± 8.3	56.0± 5.3	14.9± 0.5
0.26± 0.07	99.2± 1.7	89.9± 6.3	56.3± 9.3	56.5± 5.9	14.9± 0.4
0.37± 0.07	97.5± 3.2	89.7± 8.5	33.5± 10.3	55.9± 7.0	14.6± 0.6
0.59± 0.07	99.2± 1.7	91.6± 3.3	9.2± 4.1	73.3± 19.0	15.9± 1.1
0.93± 0.14	98.3± 1.9	81.3± 7.3	0.9± 1.7	2	8

Validity criteria fulfilled:

not applicable

Conclusions:

NOEC (pimephales promelas): 11.8 mg/L NH4Cl/L
LOEC (pimephales promelas): 18.7 mg/L NH4Cl/L

Executive summary:

The 28-day chronic toxicity of ammonium chloride to early life stage of Pimephales promelas was studied under flow through conditions. Embryos (30) of Pimephales promelas were exposed to control, solvent control, and test chemical nominal concentrations of 0.10, 0.17, 0.26, 0.37, 0.59, 0.93 mg NH₃-N/L. The test system was maintained at 24 °C and a pH of 8.2 to 8.4. The 28-day LOEC and NOEC values, based on survival, were 18.7 and 11.8 mg/L, respectively. Embryo survival showed no concentration-related effects, with hatching success ranging from 97.5 to 100 %. There was a significant (alpha = 0.05) decrease in the number of normal larvae which hatch at the 18.7 mg NH₄Cl/L level and higher abnormalities such as small, poorly developed larvae and scoliosis were the most frequently observed effects. Larval survival showed a concentration-related response, with a significant (alpha = 0.05) decrease at 18.7 mg NH₄Cl/L and higher. There was no significant (alpha = 0.05) decrease in growth at any of the concentrations tested; however, there was a significant increase in weight at the 11.8 mg NH₄Cl/L level and higher. The increase in weight may be attributed to smaller numbers of fish at the higher concentrations, which reduced crowing effects and also resulted in more food per individual fish.

The study makes use of appropriate methods as outlined in the OECD test guideline 210. Results can therefore be regarded as reliable in this study.

Results synopsis

Test organism size/age: Embryos less than 24 h old

Test type: Flow-through

LOEC: 18.7 mg/L

NOEC: 11.8 mg/L

Endpoint(s) effected: Survival

This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reference 3

Endpoint:

fish short-term toxicity test on embryo and sac-fry stages

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Justification for type of information:

For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

ca. 8 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

weight

Duration:

28 d

Dose descriptor:

LOEC

Effect conc.:

ca. 16 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

weight

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

ca. 65 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

28 d

Dose descriptor:

LOEC

Effect conc.:

ca. 141 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

Measured concentrations were used to calculate. Salinity; 31 g/kg, pH; between 7 and 8, dissolved oxygen; not shown.
NH3 toxicity to inland silversides was greatest at pH 7.0 and 9.0 and lowest at pH 8.0. In silversides at a salinity of 11 g/kg, NH3 toxicity was less at pH 7.0, greater at pH 8, and slightly less at pH 9, relative to the toxicity at a salinity of 31 g/kg.
28 d NOEC (survival) = 65.0 mg/L
28 d LOEC (survival) = 141 mg/L
28 d NOEC (growth weight) = 8.0 mg/L
28 d LOEC (growth weight) = 16.0 mg/L

Conclusions:

NOEC (survival) = 65.0 mg/L
LOEC (survival) = 141 mg/L
NOEC (growth weight) = 8.0 mg/L
LOEC (growth weight) = 16.0 mg/L

Executive summary:

The 28-day chronic toxicity of ammonium chloride to early life stage of Menidia beryllina was studied under static renewal conditions. 20 fish embryos of Menidia beryllina were exposed to 5 ammonia concentrations. The test system was maintained at 23.5 to 25 °C and a pH of 7.36 to 7.86. The 28-day NOEC and LOEC values, based on weight and survival, were 8 and 16 mg/L (weight) and 65 and 141 mg/L (survival), respectively.

The study is considered as supporting evidence since it only is available through a secondary source and cannot be assessed in detail. The effects reported can generally be considered reliable.

Results synopsis

Test type: Static

Based on weight:

LOEC: 16 mg/L (ammonium chloride)

NOEC: 8 mg/L (ammonium chloride)

Based on survival:

LOEC: 141 mg/L (ammonium chloride)

NOEC: 65 mg/L (ammonium chloride)

Endpoint(s) effected: Weight, survival

This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reference 4

Endpoint:

fish short-term toxicity test on embryo and sac-fry stages

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Justification for type of information:

For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Duration:

61 d

Dose descriptor:

NOEC

Effect conc.:

ca. 11 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

calculated from 1.2 ppb NH3

Basis for effect:

other: length, weight of fry at migration

Duration:

61 d

Dose descriptor:

LOEC

Effect conc.:

ca. 22 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

calculated from 2.4 ppb NH3

Basis for effect:

other: length, weight of fry at migration

Details on results:

The highest concentration of ammonia caused significant decreases in weight of exposed fry in all three exposure groups. At 2.4 ppb un-ionized ammonia, the groups held for 40 and 61 days were significntly smaller in length and weight but at 1.2 ppb un-ionized ammonia there was no significant difference. Effects were consistently more adverse for groups held 61 days.
LOEC (61 d) = 22 mg/l (NH4)2SO4 (calculated from 2.4 ppb NH3)
NOEC (61 d) = 11 mg/l (NH4)2SO4 (calculated from 1.2 ppb NH3)

Conclusions:

LOEC (61 d) = 22 mg/l (NH4)2SO4 (calculated from 2.4 ppb NH3)
NOEC (61 d) = 11 mg/l (NH4)2SO4 (calculated from 1.2 ppb NH3)

Executive summary:

The 61-day chronic toxicity of ammonium sulphate to the early life stage of Oncorhynchus gorbuscha was studied under flow through conditions. Alevins were exposed to the test chemical at nominal concentrations of 0 to 4 ppb. The test system was maintained at 3.7 to 4.8 °C and a pH of 6.3 to 6.5. The LOEC and NOEC values, based on length, weight of fry at migration, were 22 and 11 mg/L respectively. The highest concentration of ammonia caused significant decreases in weight of exposed fry in all three exposure groups. At 2.4 ppb un-ionized ammonia, the groups held for 40 and 61 days were significantly smaller in length and weight but at 1.2 ppb un-ionized ammonia there was no significant difference. Effects were consistently more adverse for groups held 61 days.

The study is considered as supporting evidence. The effects reported can generally be considered reliable.

Results synopsis

Test type: Flow-through

LOEC: 22 mg/L (ammonium sulphate)

NOEC: 11 mg/L (ammonium sulphate)

Endpoint(s) effected: Length, weight of fry at migration

This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reference 5

Endpoint:

long-term toxicity to fish, other

Remarks:

endocrine changes

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Justification for type of information:

For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Duration:

12 mo

Dose descriptor:

LOEC

Remarks:

Clarias batrachus

Effect conc.:

ca. 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: hypertrophy of the cortical and medullary cells, inhibition of thyroid function

Details on results:

Prolonged exposure of Clarias batrachus to sublethal doses of ammonium sulfate fertilizer induced marked hypertrophy of the cortical and medullary cells of the interrenal gland and inhibition of thyroid function evident from the follicular hypertrophy, hyperplasia, and reduced colloid content with correlative histological changes in the pituitary corticotrophs and thyrotrophs of the experimentals.

The thyrotrophes of the control fish were small, and their nuclei and nucleoli were less prominent.

Results were similar in ammonium sulfate and thiourea treated fish.

LOEC (12 Months) = 100 mg/L

Conclusions:

LOEC (12 months) = 100 mg/L (endocrine changes: hypertrophy of the cortical and medullary cells, inhibition of thyroid function)

Executive summary:

In a 12-months long-term toxicity study, adult fish of the species Clarias batrachus were exposed to ammonium sulphate at nominal concentrations of 0.01 % under renewal conditions to investigate endocrine changes. The results were compared to effects obtained from treatment with radioiodine and thiourea (10 fish per treatment group). The LOEC of ammonium sulphate based on hypertrophy of the cortical and medullary cells of the interrenal gland was 100 mg/L.

The following abnormalities were noted: Marked hypertrophy of the cortical and medullary cells of the interrenal gland and inhibition of thyroid function evident from the follicular hypertrophy, hyperplasia, and reduced colloid content with correlative histological changes in the pituitary corticotrophs and thyrotrophs of the experimentals. The thyrotrophes of the control fish were small, and their nuclei and nucleoli were less prominent.

The study is considered as supporting evidence. The effects reported can generally be considered reliable.

Results synopsis

Test organism: Clarias batrachus

Test type: Static renewal

12-months LOEC: 100 mg/L

Endpoint(s) effected: Endocrine changes

This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reference 6

Endpoint:

fish early-life stage toxicity

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Justification for type of information:

For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Duration:

6 mo

Dose descriptor:

LOEC

Remarks:

Channa punctatus

Effect conc.:

ca. 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: ovarian growth

Duration:

6 mo

Dose descriptor:

LOEC

Remarks:

Channa punctatus

Effect conc.:

ca. 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: testicular development

Details on results:

Ovarian changes:
Maturation of oocytes through stages I,II and III was inhibited in the exposed fish. In stage III oocytes, the nucleus exhibited degenerative changes.
No external manifestation of toxicity was observed, but ovarian growth was significantly reduced (gonadosomatic index of 1.13 vs 1.80 for the control).
Testicular development:
In testes of the 100 ppm group, spermatogenesis did not progress beyond spermatocyte stage and sperm were totally absent. Necrosis of spermatogenic elements and other effects were also noted. In the 500 ppm group, testes exhibited disorganization of lobules, significant inhibiton of spermatogenesis, extensive necrosis, and disintegration of spermatogenic elements. The gonado-systemic indices (= total gonad weight : total body weight × 100) were significantly reduced in the 100 ppm (0.125) and 500 ppm (0.117) treated groups relative to the control (0.166). Correlative histological changes were also observed in the pituitary gonadotrophs, in fish of both experimental groups, being smaller, involuted, inactive and less in number. The authors concluded that ammonium sulfate is inhibiting testicular development and inducing deleterious changes in spermatogenic elements either by direct action on the testis itsself or indirectly via the hypothalamic-pituitary-testicular axis in this species.

Conclusions:

Ovarian growth: LOEC: 100 mg/L
Testicular development: LOEC: 100 mg/L

Executive summary:

The 6-month chronic toxicity of ammonium sulphate to early life stage of Channa punctatus was studied under semi-static conditions. 10 adult fish (ovarian changes) and 30 adult fish of Channa punctatus were exposed to control, solvent control, and test chemical nominal concentrations of 100 ppm (ovarian changes), and 100 ppm and 500 ppm (testicular development). The test system was maintained at 20, 23, 27, 31, 32 and 35 °C (seasonal changes in temperature) and a pH of 7.2. The 6-month LOEC values, based on ovarian growth and testicular development, were both 100 mg/L. The sublethal effects included degenerative changes in the nucleus of early vitellogenic oocytes of C. punctatus. In C. punctatus exposed to 100 ppm ammonium sulphate for six months, the ovarian growth was inhibited which is characterised by the presence of large number of stage-l, less number of stage-II and few stage-III oocytes whereas the control ovary was fully matured having large number of stage-IV vitellogenic matured oocyte, few stage III, II and I oocytes. The most sensitive point was at 100 ppm ammonium sulphate.

The results of the study can be regarded as reliable concerning the effects detected. As effects were observed for the lowest concentration tested, no NOEC could be determined.

Results synopsis

Test organism size/age (mean wet weight or length): 45 ± 4 g, adult stage

Test type: Semi-static

LOEC: ≤100 mg/L

LOEC: ≤100 mg/L

Endpoint(s) effected: Ovarian changes, testicular development

This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reference 7

Endpoint:

fish early-life stage toxicity

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Reference 8

Endpoint:

fish, juvenile growth test

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Justification for type of information:

For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

pH:

7.3 (median value)

Duration:

10 d

Dose descriptor:

NOEC

Effect conc.:

ca. 66.6 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

element

Remarks:

NH3-N

Basis for effect:

weight

Remarks:

and length

Duration:

10 d

Dose descriptor:

LOEC

Effect conc.:

ca. 118 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

element

Remarks:

NH3-N

Basis for effect:

weight

Remarks:

and length

Duration:

10 d

Dose descriptor:

NOEC

Effect conc.:

ca. 134 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

element

Remarks:

NH3-N

Basis for effect:

weight

Remarks:

and length

Duration:

10 d

Dose descriptor:

LOEC

Effect conc.:

ca. 1 021 mg/L

Basis for effect:

other: length and weight

Details on results:

The NOEC for the juvenile fish, which were 6 weeks old at the start of the 10 day test, was 66.6 mg/L ammonium nitrogen. The corresponding LOEC was 118.0 mg/L ammonium nitrogen.
The NOEC for the juvenile fish, which were 9 weeks old at the start of the 10 day test, was 134.0 mg/L ammonium nitrogen. The corresponding LOEC was 227.0 mg/L ammonium nitrogen.

Conclusions:

Length and weight at pH 7.3; 6 weeks old juvenile fish:
NOEC = 66.6 mg/L NH3-N
LOEC = 118 mg/L NH3-N
Length and weight at pH 7.2; 9 weeks old juvenile fish:
NOEC = 134 mg/L NH3-N
LOEC= 227 mg/L NH3-N

Executive summary:

The 10-day chronic toxicity of ammonium sulphate to early life stage of Pimephales promelas was studied under static conditions. Juvenile fish of Pimephales promelas were exposed to control, solvent control, and test chemical concentrations of 211.2 ± 17.5, 118.0 ± 9.8, 66.6 ± 7.7, 37.0 ± 4.6, 17.4 ± 3.8 and 0 mg/L. The test system was maintained at 20 °C and a pH of 7.3. The 10-day LOEC and NOEC values, based on length and weight, were 531 and 300 mg/L for 6 weeks old juvenile fish, and 1021 and 603 mg/L for 9 weeks old fish respectively.

Results synopsis

Test organism size/age (mean wet weight or length): juvenile, 6 and 9 weeks old

Test type: Static

LOEC: 118 mg/L NH3-N (6 weeks old fish)

LOEC: 227 mg/L NH3-N (9 weeks old fish)

NOEC: 66.6 mg/L NH3-N (6 weeks old fish)

NOEC: 134 mg/L NH3-N (9 weeks old fish)

Endpoint(s) effected: Length and weight

This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reference 9

Endpoint:

fish short-term toxicity test on embryo and sac-fry stages

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Rationale for reliability incl. deficiencies:

other:

Justification for type of information:

For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

GLP compliance:

no

Duration:

44 d

Dose descriptor:

NOEC

Effect conc.:

ca. 23.9 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Duration:

44 d

Dose descriptor:

LOEC

Effect conc.:

ca. 53.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Details on results:

Hatching success was unaffected by exposure to un-ionised ammonia concentrations from control through 0.91 mg/L NH3 (p > 0.05).
The mean hatching success for all treatments, as measured by numbers of normal live larvae produced, was 73 % of the original embryos in the samples. However, by 3-4 days post-hatching 87 % (46 of 53 - one complete replicate was lost due to procedural error) of the surviving larvae in the highest exposure concentration (0.91 mg/L NH3) had developed recognisable deformities. Observed deformities were various degrees of curvature of the spine and/or pericardial oedema. Deformities among the larvae in all lower exposure concentrations were 13%.
The 10 days following hatching are a most critical period, when larval fish must make the transition from endogenous to exogenous feeding (Toetz, 1966). Mortalities during this period were extensive and reached 100 % in both replicates of the highest ammonia concentration. Once the conversion to feeding on live brine shrimp nauplii was accomplished, mortality rates were reduced but not eliminated. These results indicate that the maximum no observed adverse effect concentration, based on growth inhibition, is 0.22 mg/L NH3 and the minimum adverse effect concentration is 0.49 mg/L NH3. The geometric mean of these two values, an estimate of the chronic effect concentration, is 0.33 mg/L NH3. At 1.02 mg/L NH3 complete mortality of all larvae occurred within 10 days of hatching. Even among the second lots of fish introduced into the two replicates of the highest exposure concentration, mortalities continued to occur until termination of the study; the growth of survivors was severely retarded.

Conclusions:

NOEC = 23.9 mg/L
LOEC = 53.2 mg/L based on growth rate

Executive summary:

The 44-day chronic toxicity of ammonium chloride to early life stage of Lepomis cyanellus was studied under flow through conditions. Fertilized eggs/embryos of Lepomis cyanellus were exposed to control, solvent control, and test chemical of 5 ammonia concentrations. The test system was maintained at 22 °C and a pH of 7.9. The 44-day NOEC and LOEC values, based on growth inhibition, were 23.9 and 53.2 mg/L respectively. Hatching success was unaffected by exposure to un-ionised ammonia concentrations from control through 0.91 mg/L NH₃ (p > 0.05). The mean hatching success for all treatments, as measured by numbers of normal live larvae produced, was 73 % of the original embryos in the samples. However, by 3–4 days post-hatching 8 % (46 of 53 – one complete replicate was lost due to procedural error) of the surviving larvae in the highest exposure concentration (0 .91 mg/L NH₃) had developed recognisable deformities. Observed deformities were various degrees of curvature of the spine and/or pericardial oedema. Deformities among the larvae in all lower exposure concentrations were 13 %.

Results synopsis

Test organism size/age (mean wet weight or length): n.a.

Test type: Flow-through

LOEC: 53.2 mg/L (ammonium chloride)

NOEC: 23.9 mg/L (ammonium chloride)

Endpoint(s) effected: Growth

This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reference 10

Endpoint:

fish short-term toxicity test on embryo and sac-fry stages

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Justification for type of information:

For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

GLP compliance:

no

Specific details on test material used for the study:

´

Duration:

36 d

Dose descriptor:

LC50

Remarks:

Salmo clarki

Effect conc.:

ca. 0.56 mg/L

Conc. based on:

other: NH3 (un-ionized)

Basis for effect:

mortality

Duration:

36 d

Dose descriptor:

LC50

Remarks:

Salmo clarki

Effect conc.:

ca. 30.8 mg/L

Conc. based on:

other: total NH3-N

Basis for effect:

mortality

Details on results:

Median lethal concentration (LC50) values for ammonia (mg/liter unionized NH3) were 0.5-0.8 for 96 hours, and 0.3-0.6 for 36 days. Tissues of fish exposed for 29 days to 0.34 mg/liter unionized ammonia evidenced degenerative changes in gills, kidneys, and livers. Cutthroat trout fry are comparable to rainbow trout (Salmo gairdneri) fry in their susceptibility to acute toxicity from aqueous ammonia.

The LC50 (36 days) was determined to be 0.56 mg/L NH3 (un-ionized)
The LC50 (36 days) was determined to be 30.8 mg/L (total NH3-N)

Conclusions:

The LC50 (36 days) was determined to be 0.56 mg/L NH3 (un-ionized)
The LC50 (36 days) was determined to be 30.8 mg/L (total NH3-N)

Executive summary:

The 36-day chronic toxicity of ammonium chloride to early life stage of cutthroat trout, Salmo clarki, was studied under flow-through conditions. 20 fry of Salmo clarki were exposed to control, solvent control, and test chemical 5 ammonia concentrations. The 36-day LC₅₀ values, based on mortality, were 0.56 mg unionized NH₃/L and 30.8 mg total NH₃-N/L respectively. The sublethal effects included were degenerative changes in gills, kidneys, and livers.

Results synopsis

Test organism size/age (mean wet weight or length): Fry (1–3 g)

LC₅₀: 0.56 mg unionized NH₃/L

LC₅₀: 30.8 mg total NH₃-N/L

Endpoint(s) effected: Mortality

This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Description of key information

According to REACH Annex IX 9.1 column 2, chronic toxicity tests shall only be proposed if the chemical safety assessment of a substance indicates the need to further investigate the effects on fish. The hazard assessment of ammonium-S-lactate does not indicate that the substance is hazardous to the environment. Therefore, long-term studies in fish are not considered to be required. Nevertheless, a total of 9 existing studies on ammonium salts (ammonium chloride and ammonium sulphate) are presented as additional evidence for the absence of environmental toxicity in a read-across approach, covering the ammonium moiety of ammonium-S-lactate. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

The NOEC values observed for ammonium-S-lactate (obtained by stoichiometric conversion from ammonium sulphate and ammonium chloride) range from 8.92 mg/L in a toxicity test on embryo and sac-fry stages (Rice and Bailey, 1980) to 509 mg/L in a growth test on juvenile fish (Nebeker and Schuytema, 2000). This range is explained by different test methods, the use of different species and the pH-dependent toxicity of ammonium in its ionizied versus un-ionized form.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

NOEC

Effect concentration:

ca. 8.92 mg/L

Marine water fish

Marine water fish

Dose descriptor:

NOEC

Remarks:

Meridia beryllina (Miller et al., 2003), stoichiometric conversion from NH4Cl to NH4-lactate

Effect concentration:

ca. 16 mg/L