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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Fish

LC50 (96 h, freshwater) = 32 mg/L

LC50 (96 h, marine water) = 24 mg/L

Aquatic invertebrates

EC50 (48 h) = 8.2 mg/L (geometric mean of EC0 and EC100; mean measured)

NOEC (7 -d, reprod.) = 1.09 mg/L (TWM measured)

Algae

ErC50 (72 h) = 17 mg/L (geometric mean measured)

ErC10 (72 h) = 3.7 mg/L (geometric mean measured)

Microorganisms

NOEC (Pseudomonas putida; 16 h) = 800 mg/L (buffered)

Additional information

Summary of aquatic toxicity

Fish

LC50 (96 h, freshwater) = 32 mg/L

LC50 (96 h, marine water) = 24 mg/L

The acute LC50 values for fresh water fish range between 32 and 268 mg/L (Dawson et al., 1975 and Geiger et al., 1985, respectively). They were obtained under non-neutralised (Dawson) and neutralized (Geiger) conditions, such that basicity is concluded to contribute to toxicity considerably.

Dawson et al. (1975) studied in addition toxicity to salt water / marine water fish. The tested salt water species was Tidewater Silverside (Menidia beryllina), and a LC50 (96 h) of 24 mg/L was determined.

The acute toxicity values relevant for classification are located between 10 and 100 mg/L. The result obtained on marine fish (LC50 = 24 mg/L) corresponds to that found with freshwater fish [Dawson et al. 1975].

Aquatic invertebrates

EC50 (48 h) = 8.2 mg/L (geometric mean of EC0 and EC100; mean measured)

NOEC (7 -d, reprod.) = 1.09 mg/L (TWM measured)

In the only acute study conducted on daphnids (Ceriodaphnia dubia) over 48 h, the EC50 value was found to be < 10 mg/L [Collins 1994]. The other two studies resulting in EC50 values > 10 mg/L were run for 24 h only, hence are not considered to be reliable studies [Bringmann and Kühn 1982].

In a chronic study with Ceriodaphnia dubia following the US EPA method 1002.0 (Daphnid, Ceriodaphnia dubia, Survival and Reproduction Test), a 7 -d NOEC of 1.09 mg/L for effects on reproduction (and survival) was determined based on time weighted mean measured concentrations [Collins 1994]. The method is equivalent to OECD 211 using Ceriodaphia dubia which has a shorter generation period as Daphnia magna and is able to produce 3 broods witin 7 d.

Algae

ErC50 (72 h) = 17 mg/L (geometric mean measured)

ErC10 (72 h) = 3.7 mg/L (geometric mean measured)

The key study is a GLP-guideline study according to OECD 201 performed with the freshwater algae Desmodesmus subspicatus. The concentrations are analytically verified. The ErC50 was determined at 17 mg/L, the ErC10 at 3.7 mg/L (Muckle, 2013). Based on this result, the substance is supposed to be acutely harmful to aquatic algae. Non-reliable data are available on Microcystis aeruginosa and Scenedesmus quadricauda (Bringmann/Kühn). In these studies, major methodological deficiencies are obvious: pre-cultures up to 10 days old were used for the tests: cannot be in logarithmic growth phase anymore; test duration over 8 days instead of 3 (non-logarithmic); stagnant culture, shaken only once per day; number and spacing of tested concentrations not reported; "toxic threshold" concentration derived via absorption measurements equivalent to yield - growth rates not determined; accordingly, these studie must be regarded to be invalid.

Microorganisms

NOEC (Pseudomonas putida; 16 h) = 65 mg/L (unbuffered) / 800 mg/L (buffered)

In a cellular growth inhibition test using a pure bacteria culture of Pseudomonas putida, the toxicity threshold (TTC) was determined to be 65 mg/L (NOEC) under unbuffered conditions [Bringmann and Kühn 1977, 1980]. Upon neutralisation, the corresponding toxicity threshold (TTC, approximately equivalent to an EC03) was 800 mg/L. It must be assumed that sewage is neutralized to an acceptable pH range before discharge into STP. Further, sewage will have a buffer capacity on its own such that extreme pH values will not occur. Therefore, the TTC of 800 mg/L is the relevant value to be used in hazard and risk assessment for STP microorganisms.

In support of this value is the Zahn-Wellens test on inherent biodegradability (1977/1980). The initial concentration applied was 1000 mg/L COD (neutralized), and very rapid biodegradation was observed (90 % within 2 days, 100% within 5 days). This allows to exclude any relevant inoculum toxicity at this concentration.

In a 7-d toxicity pre-test preceding the main biodegradation study, 100 mg n-butylamine/L failed to inhibit the metabolism of the inoculum (here: activated sludge), indicated by highly efficient metabolic oxidation of glucose and n-butylamine itself (Yoshimura et al. 1980: see Section 5.2.1).

The other three pioneer studies referred to are based on pure cultures of non-standard test organisms (protozoae). All three organisms are of low relevance for the STP process (organisms feeding on bacteria). No standardized testing protocols do exist and thus reliability of the study outcome is not assessable. In conclusion, these are unsuitable test systems, and studies on Entosiphon and Chilomonas are disregarded [Bringmann and Kühn 1978 - 1982].

Summary of aquatic toxicity results for n-butylamine

Endpoint

Organism group

Species

Value [mg/L]

Reliability

Remarks

Source

FISH

96h LC50

Fish, freshwater

Lepomis macrochirus

32 (not buffered)

2

(Key study #1)

nominal, static

Dawson et al. 1975

96h LC50

Fish, freshwater

Pimephales promelas

268 (neutral)

1
(Supp. study)

analytically verified, flowthrough

Geiger et al. 1985

96h LC50

Fish, salt water

Menidia beryllina

24 (not buffered)

2
(Key study #2

nominal, static

Dawson et al. 1975

48h LC50

Fish, freshwater

Leuciscus idus

171 / 236

(not buffered)

3

nominal, static
(2 studies)

Juhnke and Lüdemann 1978

48h LC0

Fish, freshwater

Leuciscus idus

100

4

nominal, static

Hoechst AG 1977

DAPHNIA

48h LC50

Aquatic invertebrates

Ceriodaphnia dubia

8.2

1
(Key study)

Analytically verifed, semi-static

Collins 1994 (Springborn)

24h EC50

Aquatic invertebrates

Daphnia magna

43

3

nominal, static

Bringmann and Kühn 1982

24h EC50

Aquatic invertebrates

Daphnia magna

75

3

nominal, static

Bringmann and Kühn 1982

7d NOEC
mortality / reproduction
(long-term)

Aquatic invertebrates

Ceriodaphnia dubia

1.5 (reprod.)

3 (mortality)

2

(Key study)

Analytically verified,
semi-static

Collins 1994 (Springborn)

ALGA / CYANOBACTERIA

72h ErC50 / ErC10

algae

Desmodesmus subspicatus

17 / 3.7

1

(Key study)

nominal, static

Muckle 2013

8d EC0 (long-term)

algae

Scenedesmus quadricauda

0.54-0.55

3

nominal, static

Bringmann and Kühn 1977 -1980

8d EC0 (long-term)

cyano bacteria / blue algae

Microcystis aeruginosa

0.14

3

nominal, static

Bringmann and Kühn 1977 -1980

MICROORGANISM

16h NOEC

Microorganisms:

bacteriae

P. putida

65 (alkaline)
800 (neutral)

2

(Key study)

nominal, static

Bringmann and Kühn 1977, 1980

72h EC0

Microorganisms:

protozoae

Entosiphon sulcatum

8.8 (neutral)

3, disregarded

nominal, static

Bringmann and Kühn 1978, 1980

48h EC0

Microorganisms:

protozoae

Chilomonas paramaecium

53 (neutral)

3, disregarded

nominal, static

Bringmann and Kühn 1980, 1981

20h EC0

Microorganisms:

protozoae

Uronema parduzci

1752 (neutral)

3

nominal, static

Bringmann and Kühn 1980