m-toluidinium chloride

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

not given

Reliability:

3 (not reliable)

Justification for type of information:

As m-toluidine hydrochloride dissociates into m-toluidine and hydrochloride the studies concerning the ecotoxicology of m-toludine are considered relevant for the registration according to REACH.

Data source

Reference

Reference Type:

publication

Title:

SIDS initial assessment profile: m-Toluidine (CAS No. 108-44-1)

Author:

OECD

Year:

2001

Bibliographic source:

SIAM 11, 23-26 January 2001, pp1-2

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

m-toluidine

EC Number:

203-583-1

EC Name:

m-toluidine

Cas Number:

108-44-1

Molecular formula:

C7H9N

IUPAC Name:

m-toluidine

Test material form:

not specified

Sampling and analysis

Analytical monitoring:

not specified

Details on sampling:

not given

Test solutions

Vehicle:

yes

Details on test solutions:

Stock solutions preparation: DMSO was used as a solvent (Final concentration: 6.12-648 mg/L)

Test organisms

Test organisms (species):

Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)

Details on test organisms:

ATC 22662

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Test temperature:

23 to 25 °C

Nominal and measured concentrations:

6.8 mg/L, 12.4 mg/L, 22.2 mg/L, 40 mg/L, 72 mg/L (nominal)

Details on test conditions:

Growth/test medium: OECD medium
Shaking: Occasional shaking
Exposure vessel type: 100 mL-medium in a 300 mL-Erlenmeyer flask with a silicon cap which allow ventilation
Light levels and quality during exposure: 4000-7000 Lux, continuous
Number of replicates: 3 parallel runs for each concentration
Initial cell number: 1.0*10000 cells/mL
Controls with and without vehicle were taken for test

Reference substance (positive control):

not required

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

53.11 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 2

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

17.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

biomass

Effect concentrations 3

Duration:

72 h

Dose descriptor:

EC10

Effect conc.:

24.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 4

Key result

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

< 6.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

biomass

Details on results:

In the report of the reference the toxicity of m-Toluidine to algae was calculated on the basis of bio mass. According to the Guidance on information requirements and chemical safety assessment R.7b (ECHA, 2012) results based on the biomass should not be used for assessment since biomass results depend on the growth rate of the species as well as the test duration and other elements of the test design.

Reported statistics and error estimates:

statistical method: probit method

Applicant's summary and conclusion

Validity criteria fulfilled:

no

Conclusions:

For m-toluidine on the green algae Selenastrum capricornutum a 72h-EC10 of 24.8 mg/L and a 72h-EC50 of 53.11 mg/L were obtained based on growth rate.

Executive summary:

As m-toluidine HCl dissociates in aqueous solution into m-toluidine and hydrochloride the studies concerning the ecotoxicology of m-toludine are considered relevant for the registration according to REACH.

Following the OECD Guideline 201 (Alga, Growth Inhibition Test) a 72h-EC10 of 24.8 mg/L and a 72h-EC50 of 53.11 mg/L was received on Selenastrum capricornutum (new name: Pseudokirchnerella subcapitata). The values are based on nominal concentration as no analytical monitoring was performed.

In the report of the reference the toxicity of m-Toluidine to algae was calculated on the basis of bio mass. According to the Guidance on information requirements and chemical safety assessment R.7b (ECHA, 2012) results based on the biomass should not be used for assessment since biomass results depend on the growth rate of the species as well as the test duration and other elements of the test design.

The study cannot be fully validated. Thus, the information given has been rated as Klimisch 3 (not reliable). The information cannot be used to classify m-toluidine HCl as toxic to algae.