2,2'-[(4-methylphenyl)imino]bisethanol

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

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:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

yes

Conclusions:

Based on the available read-across data, it is concluded that the target substance does not cause any visible or lethal effects in carp up to the analytically confirmed concentration of 100 mg/L (NOEC). The LC50 (96 h) exceeds 100 mg/L.

Executive summary:

The short-term toxicity of the source substance Accelartor (PT 25 E or PT 25E/2) was assessed according to OECD guideline 203. In a static limit test, carp (Cyprinus carpio) were exposed to Accelerator (PT 25E or PT 25E/2) at the nominal concentration of 0 (blank-control) and 100 mg/L for 96 h. After 96 h, Accelerator (PT 25E or PT 25E/2) induced no visible or lethal effects in carp at an analytically confirmed concentration of 100 mg/L. The 96h-LC50 exceeded 100 mg/L based on analytically confirmed exposure concentrations. 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 target substance does not cause any visible or lethal effects in carp up to a nominal concentration of 100 mg/L. The LC50 (96 h) exceeded 100 mg/L.

Description of key information

LC50 (96 h) > 100 mg/L (nominal, OECD 203, C. carpio); read-across

Additional information

There is no guideline study available, in which the short-term toxicity of the target substance N,N-Dihydroxyethyl-p-toluidine (CAS 3077-12-1) to fish 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 fish. A detailed read-across approach justification is provided in IUCLID section 13.

 

By means of the read-across approach one key study is available for the source substance (reliability 1, according to Klimisch score) and an additional supporting study with the target substance itself (reliability 4, according to Klimisch score due to insufficient documentation).

In the available study with the source substance, a static limit test according to OECD guideline 203 was performed, in which carp (Cyrpinus carpio) were exposed to a limit concentration of 100 mg/L for 96 h. A negative control was run in parallel and test item concentrations in the test vessels were analytically verified. After 96 h, no visible or lethal effects were observed at the analytically confirmed test item concentration of 100 mg/L, resulting in an LC50 (96 h) of > 100 mg/L.

This result is confirmed by the available supporting study with the target substance itself where no toxicity to fish was recorded after an exposure of 96 h up to a concentration of 100 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 target substance N,N-Dihydroxyethyl-p-toluidine (CAS 3077-12-1) does not cause acute toxic effects to fish up to a nominal concentration of 100 mg/L. This is further confirmed by the available study for the target substance itself.