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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Description of key information

According to the study on hydrolysis (CIBA Inc. 2009), the substance EC 401-280-0 hydrolyses instantly when it comes into contact with water. Therefore, available aquatic toxicity studies performed with substance EC 401-280-0 are regarded as valid since the test organisms are exposed to the environmentally relevant degradation products.

Following experimental data with substance EC 401-280-0 on aquatic toxicity are available: Short term toxicity to fish, Short-term toxicity to aquatic invertebrates, Toxicity to aquatic algae and Toxicity to microorganisms.

The EC50 values for fish, Daphnia and algae range between 1 and 10mg/L indicating acute toxicity to aquatic organisms. A slight toxicity was also observed in a toxicity test with acitvated sludge (EC 50 = 100mg/L). However, no long-term toxicity tests with the substance EC 401-280-0 on fish and aquatic invertebrates are available. Additionally, the test on short-term toxicity to aquatic invertebrates showed toxicity but the exposure was only 24 hours instead of 48 hours.

Data on the degradation products were additionally evaluated. After hydrolysis the degradation products will consist mainly of bis(2-ethylhexyl)amine (ca 70%), about 20% of the hydrolysate will be 1H-1,2,4-triazole and about 10% formaldehyde (taking into account the individual molecular masses).

Additional information

Hydrolysis products:

bis(2-ethylhexyl)amine

The major hydrolysis product bis(2-ethylhexyl)amine is classified as Aquatic Chronic 1 (M-Factor 1) according to Regulation (EC) No 1272/2008. It does not fulfil the criteria for PBT or vPvB according to Regulation (EC) No 1907/2006. The water solubility is 14mg/L, it is not readily biodegradable and of limited mobility in soil. Both data on short-term and long-term aquatic toxicity are available and show adverse effects.The acute L(E)C50 values for fish and aquatic invertebrates were determined to be in the same magnitude. Based on the results from a long-term reproduction study with Daphnia magna, the substance is classified as Chronic Category 1. A long-term toxicity study with fish is not available and will not provide any relevant additional information.

1H-1,2,4-triazole

1H-1,2,4-triazole is not classified for environmental hazards according to CLP (Regulation (EC) No 1272/2008) and is not PBT or vPvB according to Regulation (EC) no 1907/2006. It is well soluble in water but not readily biodegradable. However, significant degradation was observed in soil. The substance is expected to be mobile in soil. The EC50 of the short term toxicity data on Daphnia is > 100mg/L. The EC50 for fish is 97 mg/L. No toxicity to microorgamisms was observed. Based on the ErC50 72h algae is the most sensitive organism (ErC50 10-100mg/L), however the ErC10 72h algae is > 1mg/L. Chronic aquatic toxicity data are only available on fish (OECD 215) showing no effect on growth rate and mortility (NOEC 28d > 100mg/L) (ECHA disseminated REACH Dossier, 16 July 2014). Based on these data no chronic toxicity in Daphnia is expected. 1H-1,2,4-triazole is only a minor degradation product of EC 401-280-0.Thus, aquatic toxicity data on 1H-1,2,4-triazole are not regarded as relevant to evaluate the acute and chronic aquatic toxicity of the substance EC 401-280-0 and its hydrolysate and is therefore not separately considered.

Formaldehyde

Formaldehyde is not classified for environmental hazards according to CLP (Regulation (EC) No 1272/2008) and is not PBT or vPvB according to Regulation (EC) No 1907/2006. It is well soluble in water and readily biodegradable and is expected to be mobile in soil if not biodegraded. Acute toxicity data on fish, Daphnia and algae indicate that formaldehyde is acutely toxic to aquatic orgnaisms (EC50 values 1 -10mg/L). Formaldehyde is toxic to microorganisms (EC50 19mg/L) which is to be expected as formaldehyde is used as disinfectant. No data from guideline studies on chronic fish toxicity is available or reliable data on long-term toxicity on aquatic invertebrates are available, respectively. As formaldehyde is readily biodegradable, data on chronic toxicity are not considered to be relevant to assess chronic toxicity of the substance EC 401-280- 0 and its hydrolysate. It is only a minor part of the hydrolysis products.

Overall, aquatic toxicity data on formaldehyde are not separately considered to evaluate the acute and chronic aquatic toxicity of the substance EC 401-280-0 or its mixture of hydrolysis products, respectively.

Conclusion

Comparing the available aquatic toxicity data on the substance EC 401 -280 -0 with the data of the major hydrolysis product bis(2 -ethylhexyl)amine shows that aquatic toxicity is in the same range. In most cases the derived effect concentrations of bis(ethyhexyl)amine are lower. Therefore, aquatic toxicity data of the most hazardous component of the hydrolysate (bis(2-ethylhexyl)amine) is used as worst case to assess the acute toxicity to aquatic invertebrates and chronic aquatic toxicity of the substance EC 401-280-0 and its hydrolysate.

Relevant data:

 

EC 401-280-0

Bis(2-ethylhexyl)amine

Short-term toxicity to fish

EC50 (96h) 1.1mg/L

EC50 (96h) >1.5 – 2.2 mg/L

Long-term toxicity to fish

No data

No data

Short-term toxicity to aquatic invertebrates

EC50 (24h) 9.3 mg/L

EC50 (48h) 2.2 mg/L

Long-term toxicity to aquatic invertebrates

No data

NOEC (21d) 0.069 mg/L

Toxicity to aquatic algae

ErC50 (72h) > 1mg/L

NOErC (72h) 0.32mg/L

ErC50 (72h) 1.55 mg/L

ErC10 (72h) 0.14 mg/L

Toxicity to microorganisms

EC50 (3h) 100 mg/L

EC50 (3h) 89 mg/L