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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Refer to the analogue approach justification provided in IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
48 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks:
(including mortality)
Remarks on result:
other: 95% CL: 27 to 75 mg/L
Validity criteria fulfilled:
yes
Conclusions:
Based on the available read-across data, it is concluded that the key value for the short-term toxicity of the target substance to aquatic invertebrates is an EC50 (48 h) of 48 mg/L and the corresponding NOEC (48 h) is 32 mg/L.
Executive summary:

The short-term toxicity of the the source substance Accelerator (PT 25E or PT 25E/2) was assessed according to OECD guideline 202. In a static test, Daphnia magna were exposed to the nominal concentrations of 0 (blank control), 10, 18, 32, 56 and 100 mg/L for 48 h. Accelerator (PT 25E or PT 25E/2) did not induce significant acute immobilisation of Daphnia magna at 32 mg/L after 48 hours of exposure. The 48h-EC50 was 48 mg/L based on analytically confirmed nominal exposure concentrations (95% confidence interval between 27 and 75 mg/L). The study is considered to be reliable without restrictions.

The target substance is expected to have a similar ecotoxicological profile as the source substance based on the high degree of structural and chemical similarity between the source and the target substances. Therefore, it is concluded that the key value for the short-term toxicity of the target substance to aquatic invertebrates is an EC50 (48 h) of 48 mg/L and the corresponding NOEC (48 h) is 32 mg/L.

Description of key information

EC50 (48 h) = 48 mg/L = 26.4 mg a.i./L (nominal, OECD 202, D. magna); read-across

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
26.4 mg/L

Additional information

There is no study available, in which the short-term toxicity of the target substance N,N-Dihydroxyethyl-p-toluidine (CAS 3077-12-1) to aquatic invertebrates was assessed. Therefore, read-across to the structurally and chemically closely related source substance Reaction mass of 2,2'-[(4-methylphenyl)imino]bisethanol and Ethanol 2-[[2-(2-hydroxyethoxy)ethyl](4-methylphenyl)amino]- (EC 911-490-9) was performed in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5 in order to meet the standard information requirements laid down in Annex VIII of REACh Regulation (EC) No 1907/2006. Based on the high degree of physico-chemical similarity between the target and source substance, the selected source substance is considered a suitable representative for the assessment of the short-term toxicity of the target substance to aquatic invertebrates. A detailed read-across approach justification is provided in IUCLID section 13.

In the available study with the source substance, a static test according to OECD guideline 202 was performed, in which water fleas (Daphnia magna) were exposed to the nominal test item concentrations of 10, 18, 32, 56, and 100 mg/L including a negative control. The test item concentrations in the test vessels were analytically verified and it was shown that the substance concentration was stable throughout the exposure.

After 48 h, no effects were observed up to the nominal concentration of 32 mg/L, resulting in a NOEC (48 h) of 32 mg/L and an EC50 (48 h) of 48 mg/L.

Based on the high degree of structural and chemical similarity between the target and the source substance and since the target substance is the main constituent of the source substance, the target substance is expected to exhibit a similar ecotoxicological profile as the selected source substance. Therefore, it is concluded that the key value for the short-term toxicity of the target substance N,N-Dihydroxyethyl-p-toluidine (CAS 3077-12-1) to aquatic invertebrates is an EC50 (48 h) of 48 mg/L, corresponding to 26.4 mg a.i./L based on the percentage of target substance content in the source substance.