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Long-term toxicity to fish

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Description of key information

No data available; however, long-term effects on fish are not expected.

Key value for chemical safety assessment

Additional information

Long-term toxicity testing on fish (Annex IX, Section 9.1.6.1.)

Description of available data

Ecotoxicity

Short-term toxicity data are available for all three trophic levels (fish, aquatic invertebrates and algae).

In case of fish, the key study by Brooke et al. (1984) was performed according to an APHA method (1980) using Pimephales promelasas test species. Exposure conditions were flow-through. Test concentrations were analytically verified. The 96-h LC50 was determined to be 1010 mg/L (meas.) using pH-adjusted test solutions. In a further study this values was supported with a 96-h LC50 of 1267 mg/L (meas., pH-adj.,P. promelas; Broderius et al., 1995).

It is reasonable to conclude that the substance is with high probability acutely not harmful to fish after pH-adjustment (96-h LC50 > 100 mg/L).

No further data on the toxicity to fish, aquatic invertebrates and algae are available for 1,2-propanediamine (CAS 78-90-0). Therefore, a read-across was performed to the structurally similar substance 1,3-propanediamine (CAS 109-76-2) for data on aquatic invertebrates and algae.

It was concluded that the substance is acutely harmful to aquatic invertebrates based on a guideline study withDaphnia magna(48-h EC50 = 27.0 mg/L; nom.; BASF AG, 1989; report no. 1/0498/2/89-0498/89). Long-term effects on aquatic invertebrates were investigated in a reproduction study withD. magnaas test species according to OECD 211. The 21-d NOEC was determined to 10 mg/L (nom., analyt. verified), which was the highest tested concentration (BASF SE, 2014, report no. 51E0218/02E009). Therefore, long-term effects on aquatic invertebrates are not expected.

The substance is with high probability acutely not harmful to freshwater algae (Desmodesmus subspicatus). Long-term effects are not expected. In a study according to DIN 38412-9, the 72-h NOEC (based on growth rate) was determined to be > 500 mg/L (nom.) in pH-adjusted test solutions (BASF AG, 1990, report no. 2/w498/89).

 

Classification

With regard to CLP, 1,2-propanediamine is not to be classified as acutely or chronically hazardous to the environment based on the available acute and chronic data. In accordance with Regulation (EC) No 1272/2008, Annex VI Table 3.2, the substance is not officially classified with regard to environmental hazards.

The substance is not to be classified as acutely hazardous to the aquatic environment, since the lowest acute effect value is >> 1 mg/L (aquatic invertebrates: EC50 = 27 mg/L).

Chronic toxicity data are available for daphnids (NOEC10 mg/L) and algae (NOEC > 500 mg/L). According to the criteria outlined in Table 4.1.0(b)(ii) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008 for rapidly degradable substances), the substance is not to be classified as chronically hazardous to the aquatic environment.

Fish is the trophic level which is not covered by chronic data. Therefore, classification is based on the respective acute data; for fish, the LC50 was determined to be 1010 mg/L. The substance is readily biodegradable (see IUCLID Ch. 5.2.1); the log Kow is < 4 (log Kow = -1.20; see IUCLID Ch. 4.7). According to the criteria outlined in Table 4.1.0(b) (iii) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008), the substance is not to be classified as chronically hazardous to the aquatic environment.

 

Long-term toxicity to fish

For reasons of animal welfare and in accordance with the REACH Guidance R.7b,R.7.8.5.3,the information requirements for fish of Annex IX can be adapted by omitting the long-term toxicity test with fish according to Annex I and IX of Regulation (EC) No 1907/2006. The applied method is the relative species sensitivity. 

In case of 1,2-propanediamine (CAS 78-90-0), long-term toxicity data are available for aquatic invertebrates and algae by means of read-across, but not for fish. Regarding acute toxicity, aquatic invertebrates have a higher sensitivity than fish or algae (48-h EC50 = 27 mg/L. For algae , the 72-h ErC50 is greater than 500 mg/L by means of pH-adjusted test solutions. The 96-h LC50 for fish is 1010 mg/L with pH-adjustment. The resulting factor between aquatic invertebrates and fish is greater than 10 (factor = 37.4).

The available long-term toxicity data for aquatic invertebrates and algae support the conclusion that aquatic invertebrates are the most sensitive trophic level. In addition, the data lead to the conclusion that long-term effects are not to be expected. No effects were observed for aquatic invertebrates up to and including the highest tested concentration of 10 mg/L. For algae, an ErC10 of 126.8 mg/L was determined without pH-adjustment and a NOEC of > 500 mg/L after pH-adjustment.

Considering the possibility for the prediction of relative species sensitivities according to the REACH Guidance Document R.7b, chapter R.7.8.5.3, further testing on fish would not contribute to improve the current knowledge of the substance and/or its associated risk when released to the aquatic compartment.

 

Overall conclusion on long-term toxicity testing on fish

1.    Experimental acute toxicity data are available for all three trophic levels (fish, aquatic invertebrates and algae).

a.    Fish:         96-h LC50 = 1010 mg/L (meas., pH-adjusted)

b.   Aq. inv.:    48-h EC50 = 27 mg/L (nom., not pH-adjusted)

c.    Algae:       72-h ErC50 = 175.1512 mg/L (nom., not pH-adjusted)
                  72-h ErC50 > 500 mg/L (nom., pH-adjusted)

2.    Experimental long-term toxicity data are available for aquatic invertebrates and algae:

a.    Aq. inv.:    21-d NOEC10 mg/L (meas., not pH-adjusted)

b.   Algae:       72-h ErC10 = 126.8 mg/L (nom., not pH-adjusted)

                  72-h NOErC > 500 mg/L (nom., not pH-adjusted)

3.    Relative species sensitivity: Based on the available experimental acute toxicity data, the factor between the least sensitive species (aquatic invertebrates, EC50 = 27.0 mg/L) and fish (LC50 = 1010 mg/L) is 37.4. This value is > 10 as stated in section R.7.8.5.3 of the REACH Guidance Document R.7b.
It can be concluded that fish is the least sensitive trophic level. Reliable and valid long-term toxicity data are available for the more sensitive trophic levels aquatic invertebrates and algae. Therefore, further long-term toxicity testing on fish would not improve the current knowledge of 1,2-propanediamine and/or its associated risk when released to the aquatic compartment.

4.    In addition, 1,2-propanediamine is not a PBT nor a vPvB substance.

5.    Further, it should be taken into consideration that 1,2-propanediamine is not officially classified with regard to environmental hazards and is also not to be classified as acutely or chronically hazardous to the environment according to CLP.

6.    Waiver for the endpoint “Long-term toxicity testing on fish” (Annex IX, Section 9.1.6. of the REACH Regulation):
In Annex IX, Section 9.1.6, Column 2 of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity testing on fish shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on fish. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to CLP-Regulation (EC) No 1272/2008 and its second adaptation 286/2011 or is assessed to be a PBT or vPvB.
The hazard assessment of the substance reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment.
 
Considering the possibility for the prediction of relative species sensitivities according to the REACH Guidance Document R.7b (ECHA, June 2017, v4.0), chapter R.7.8.5.3, further testing on fish would not contribute to improve the current knowledge of the substance and/or its associated risk when released to the aquatic compartment. This conclusion is based on a factor of greater than 10 for fish to aquatic invertebrates.
In Annex XI, Section 3, it is laid down that testing in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report (“Substance-Tailored Exposure-Driven Testing”). In accordance with Annex XI Section 3, it can be demonstrated in the risk assessment that the manufacture and the use of the substance do not pose an unacceptable risk for all environmental compartments as the risk characterization ratios (RCRs) of the chemical safety assessment are below 1 for all compartments (see Chemical Safety Report Ch. 10).
 

Therefore, and for reasons of animal welfare, a chronic test in fish is not provided.