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

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

long-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:

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

Reason / purpose for cross-reference:

read-across source

GLP compliance:

no

Duration:

21 d

Dose descriptor:

other: MATC

Effect conc.:

ca. 0.6 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

other: reproduction and mortality

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 0.42 - < 0.87 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

other: reproduction and mortality

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

>= 0.87 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

other: reproduction and mortality

Details on results:

The mean analysed concentrations were within 82 to 92 % of the corresponding nominal values. The ranges of the temperature, pH and dissolved oxygen measurements for all renewal periods during the study were 19.5 to 20.0°C, 8.3 to 8.6 and 8.8 to 9.2 mg/L, respectively. Survival, mean total young per daphnid and mean brood size were equally sensitive and differed significantly from the controls at 0.87 mg NH3-N/L and higher. The MATC, expressed as the geometric mean of 0.42 and 0.87, was 0.60 mg NH3-N/L.

Table 1: Results of chronic exposure Daphnia magna to ammonia for 21 d.

Mean analyzed concentration (mg NH3-N/L)	Survival (%)	Mean total young/Daphnid	Mean total number of broods/Daphnid	Mean brood size/Daphnid
0	100	66.7±4.3	4.0±0.3	17.5±0.6
0.22±0.05	95±10	67.6±6.4	3.6±0.7	17.7±0.5
0.42±0.07	100	62.7±5.2	3.6±0.5	17.4±0.2
0.87±0.13	85±10	49.3±4.2	3.4±0.7	14.7±0.6
1.88±0.16	35±25	28.3±3.3	2.6±1.5	9.1±0.3
3.65±0.25	0	0	0	0

Validity criteria fulfilled:

yes

Remarks:

Conducted according to ASTM guideline, but OECD 202 validity criteria are fulfilled.

Conclusions:

The 21‐d chronic value, presented as the maximum acceptable toxicant concentration (MATC), was between 0.42 and 0.87 mg NH3‐N/L. Expressing the chronic value as the geometric mean of 0.42 and 0.87 resulted in an MATC of 0.60 mg NH3‐N/L.

Executive summary:

The 21-d chronic toxicity of ammonium chloride to Daphnia magna was studied under semi-static conditions. Daphnids were exposed to the control and the test chemical for 21 d at measured concentrations between 0 and 3.65 mg/L (see Table 1 under Results). Mortality was observed daily. The 21-d chronic value, presented as the maximum acceptable toxicant concentration (MATC), was at 0.60 mg NH3-N/L.

Although this study is conducted according to thestatic renewal method described by Gersich (1984), methods align with the OECD Test Guideline No. 211.Results can therefore be regarded as valid and a Klimisch 2 has been assigned for this study.

Results synopsis

Test organism age: Neonates (< 24 h)

Test type: semi-static

MATC: 0.60 mg NH₃-N/L -> 41.3 total NH3-N/L (ammonium-(S)-lactate)

NOEC: >= 0.42 - < 0.87 mg NH₃ -N/L -> >= 28.67 - < 59.39 mg/L (ammonium-(S)-lactate)

LOEC: 0.87 mg NH₃ -N/L -> 59.39 mg/L (ammonium-(S)-lactate)

Endpoint(s) effected: Mortality and reproduction

The study is used in a read-across approach to assess the toxicity of ammonium-S-lactate and the observed MATC of 0.60 mg NH3 -N/L corresponds to a MATC of 41.3 total NH3 -N/L for ammonium-S-lactate. For details and justification of read-across please refer to the attached report in section 13 of IUCLID.

Reference 2

Endpoint:

long-term toxicity to aquatic invertebrates

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Description of key information

According to REACH Annex IX 6.1, column 2, further investigations of effects on aquatic invertebrates are not indicated when the substance is not classified as dangerous to the environment, and not assessed to be a PBT or vPvB substance. Neither criteria apply to ammonium-S-lactate and therefore, a long-term toxicity study in aquatic invertebrates in not considered to be required.

Nevertheless, a study on ammonium chloride is available to cover the ammonia moiety of the substance and is used in a read across approach. In this 21-day semi-static study (Gersich and Hopkins, 1986) the NOEC was determined at ≥ 0.42–< 0.87 mg NH₃-N/L (corresponding to ≥ 28.67–< 59.39 mg/L ammonium-S-lactate) and the LOEC was observed to be 0.87 mg NH₃-N/L (corresponding to 59.39 mg/L amonnium-S-lactate) based on mortality and reproduction of Daphnia magna. This observation confirms findings from short-time studies and supports the conclusion on innocuousness of ammonium-S-lactate in the environment. The study is combined with a waiver because no separate study is available for the lactate moiety of ammonium-S-lactate. Neither lactate nor ammonium-S-lactate (outlined above) are hazardous to the environment, therefore further testing is not considered to be required and in line with REACH Annex IX, 9.6.1 requirements.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

NOEC

Effect concentration:

ca. 28.67 mg/L