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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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) > 100 mg/L (nominal, OECD 203,Oncorhynchus mykiss, read-across from sodium anisate CAS 536-45-8)

Aquatic invertebrates: EC50 (48 h) = 943 mg/L (nominal, similar to OECD 202, Daphnia magna)

Algae/aquatic plant: ErC50 (72 h) > 320 mg/L (nominal, OECD 201, Pseudokirchneriella subcapitata, read-across from sodium anisate CAS 536-45-8)

Algae/aquatic plant: ErC10 (72 h) > 320 mg/L (nominal, OECD 201, Pseudokirchneriella subcapitata, read-across from sodium anisate CAS 536-45-8)

Additional information

The acute toxicity of the test item to aquatic invertebrates was investigated in a study by Kamaya et al. (2005). Daphnia magna was exposed for 48 hours to the test material at nominal concentrations of 2 mmol/L (304.3 mg/L) to 12 mmol/L (1825.8 mg/L). Samples from all concentrations and the control were checked before and after (48 h) exposure experiments by the UV spectra (400–200 nm). The EC50 (48 h) was determined at 943 mg/L.

No data are available on the toxicity of p-anisic-acid (CAS No. 100-09-4) towards fish, aquatic algae, and microorganisms. Therefore, data from the analogue substance sodium anisate (CAS 536-45-8) were used for read across. This read-across is in accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance was used for the assessment. This read-across is justified in within the analogue justification in IUCLID Section 13.

Experimental studies for sodium anisate (CAS 536-45-8) are available investigating the short-term effects on fish, aquatic algae, and microorganisms. The studies were performed according to internationally accepted guidelines in accordance with GLP.

One experimental study is available investigating the toxicity of the substance to fish. The study was conducted according to OECD 203 and 126 (GLP) using the rainbow trout Oncorhynchus mykiss under semi-static conditions. The absence of mortality at 100 mg/L indicated that fish was not the most sensitive group of test organisms and that the LC50 is greater than the limit test concentration. The measured content of the test item in the fresh as well as in aged test solution was 106% of nominal. Since the content of active ingredient in the samples was between 80 and 120% of nominal, the toxicological endpoints were evaluated using nominal test item concentrations. The LC50 (96 h) of the test item was determined to be > 100 mg/L test item (nominal). The corresponding NOEC (mortality) (96 h) was 100 mg/L test item (nominal). No sublethal effects were observed in the control and test item concentration 100 mg/L after 96 h.

One experimental study is available investigating the toxicity of the substance to aquatic freshwater algae. The study was conducted according to OECD 201 (GLP) using the freshwater algae Pseudokirchneriella subcapitata. The definitive test was carried out with the following concentration range: control, 3.2, 10, 32, 100 and 320 mg test item/L (nominal). The measured concentrations of the test item at test start (0h) and test end ranged between 90% and 109% of the nominal values. Thus, it is justified that the effect concentrations are based on the nominal concentrations. Inhibition of growth was recorded resulting in an ErC10 and ErC50 (72h) of >320 mg/L. Inhibition of yield was recorded resulting in an EyC10 of 115 mg/L and EyC50 (72 h) of >320 mg/L.

To cover the endpoint toxicity to microorganisms a biodegradation test according to OECD guideline 301F is available. The test includes a toxicity control, which contains 102.7 mg/L of the test item and 104.1 mg/L mg/L of sodium benzoate. The toxicity control attained 30% degradation after 14 days of incubation. Hence, the substance is not toxic to aquatic microorganisms in the toxicity control and the test item concentration of 102.7 mg/L can be used as NOEC.