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EC number: 201-155-9 | CAS number: 78-90-0
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
No data available; however, long-term effects on fish are not expected (72 -h NOEC =9.4 mg/L).
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 two trophic levels (fish and algae). Long-term toxicity data are available for aquatic invertebrates, therefore, no short-term toxicity data are available for aquatic invertebrates. 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. 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).
In Annex VII, Section 9.1.1, Column 2 of Regulation (EC) No 1907/2006, it is laid down that short-term toxicity testing on invertebrates (preferred species Daphnia) does not need to be conducted if there a long-term aquatic toxicity study on invertebrates is available, or shall be proposed by the registrant. A long-term toxicity study with aquatic invertebrates is available for propylenediamine (BASF SE, .rep. no.: 51E0497/09E044, 2021), therefore, an acute test with aquatic invertebrates is not provided. Long-term effects on aquatic invertebrates were investigated in a reproduction study with D. magna as test species according to OECD 211. The 21-d NOEC was determined to be > 12 mg/L, which was the highest tested concertation during the study (nom., analyt. verified). Therefore, long-term effects on aquatic invertebrates are not expected. An algal Inhibition test was performed according to EU Method C.3. The 72-h ErC50 the substance was determined to be 68 mg/L and the NOEC was found to be 9.4 mg/L (nom., Bayer AG, 1992). No analytical verification was performed during the study. However, it is assumed that the test concentrations remained stable over the exposure period based on a sufficient water solubility, a low Henry's Law constant and a low adsorption potential (log Kow and log Koc < 3).
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 (algae: EC50 = 68 mg/L).
Chronic toxicity data are available for daphnids (NOEC>12 mg/L) and algae (NOEC = 9.4 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, but not for fish. Regarding acute toxicity, algae have a higher sensitivity than fish (72-h EC50 = 68 mg/L). The 96-h LC50 for fish is 1010 mg/L with pH-adjustment. The resulting factor between algae and fish is greater than 10 (factor = 14.8).
The available long-term toxicity data for aquatic invertebrates and algae support the conclusion that algae 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 12 mg/L. For algae, a NOEC of 9.4 mg/L was determined.
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 two trophic levels (fish and algae). For aquatic invertebrates long-term data available, therefore, no short-term with aquatic invertebrates study was performed.
a. Fish: 96-h LC50 = 1010 mg/L (meas., pH-adjusted)
b. Algae: 72-h ErC50 = 68 mg/L (nom., not-pH-adjusted)
2. Experimental long-term toxicity data are available for aquatic invertebrates and algae:
a. Aq. inv.: 21-d NOEC > 12 mg/L (meas., not pH-adjusted)
b. Algae: 72-h NOEC = 9.4 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 (algae, EC50 = 68.0 mg/L) and fish (LC50 = 1010 mg/L) is 14.8. 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.
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