Recyclamine R 501

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

accepted calculation method

Justification for type of information:

Data is from computational model developed by USEPA

Qualifier:

according to guideline

Guideline:

other: Modelling database

Principles of method if other than guideline:

Estimation 48 hrs LC50 value of test chemical on aquatic invertebrates by EPI Suite ECOSAR version 1.11.

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea

Test type:

static

Water media type:

freshwater

Total exposure duration:

48 h

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

531.896 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Neutral Organic SAR (Baseline Toxicity)

Validity criteria fulfilled:

not specified

Conclusions:

Based on effect of test chemical on the mobility of the test organism Daphnia magna, the 48 hrs LC50 value was estimated to be 531.896 mg/l.

Executive summary:

The short-term toxicity of the test chemical to aquatic invertebrates was predicted using EPI Suite ECOSAR version 1.11. On the basis of effect of test chemical observed in a static system on the mobility of the test organism during the 48 hr exposure duration, the lethal effect concentration (LC50) for the test chemical was estimated to be 531.896 mg/l. Thus, based on the LC50 value, test chemical was considered as non-toxic and hence, considered to be 'not classified' as per the CLP classification criteria.

Description of key information

The short-term toxicity of the test chemical to aquatic invertebrates was predicted using EPI Suite ECOSAR version 1.11. On the basis of effect of test chemical observed in a static system on the mobility of the test organism during the 48 hr exposure duration, the lethal effect concentration (LC50) for the test chemical was estimated to be 531.896 mg/l. Thus, based on the LC50 value, test chemical was considered as non-toxic and hence, considered to be 'not classified' as per the CLP classification criteria.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

531.8 mg/L

Additional information

Predicted data of the target chemical and various supporting weight of evidence studies for its read across analogue were reviewed for short term toxicity to aquatic invertebrates endpoint which are summarized as below:

 

The short-term toxicity of the test chemical to aquatic invertebrates was predicted using EPI Suite ECOSAR version 1.11. On the basis of effect of test chemical observed in a static system on the mobility of the test organism during the 48 hr exposure duration, the lethal effect concentration (LC50) for the test chemical was estimated to be 531.896 mg/l.

 

In a supporting weight of evidence study from study report,to evaluate the influence of the test item on the mobility and survival of Daphnia magna an Acute Immobilisation Test according to OECD TG 202, EU Method C.2. and US EPA OCSPP 850.1010 was carried out under static conditions and in compliance with the GLP principles. Five animals in four replicates were exposed for 48 hours to nominal test item concentrations of 6.25, 12.5, 25, 50 and 100 mg/L. In addition, a blank control including the test medium but without the test item was performed. The test item concentrations were analytically verified by using HPLC-UV to be 5.715, 12.43, 25.93, 50.37 and 102.66 mg/L after 48 hours. The test item concentration was thus 91 – 104 % of the nominal at the end of the experimental phase (at the start of the test: 95 –100 of the nominal). Therefore, all biological results are based on nominal concentrations. The suitability of the test system was confirmed by a positive control with the reference substance potassium dichromate (24h EC50 = 1.12 mg/L). All validity criteria of the test guidelines were fulfilled. The mobility of the test animals was recorded after 24 and 48 hours of exposure. As a result, the 48-hour EC50 of the test item was determined to be >100 mg/L in nominal (95 % conf. limits: 91.4 – 331.8 calculated). The 48-hour EC10 was found to be 66.1 mg/L in nominal (95 % conf. limits: 18.7 – 82.5 mg/L).

 

For the test chemical, an acute Immobilisation Test according to OECD TG 202, EU Method C.2. and US EPA OCSPP 850.1010 was carried out under static conditions and in compliance with the GLP principles. Five animals in four replicates were exposed for 48 hours to nominal test item concentrations of 6.25, 12.5, 25, 50 and 100 mg/L. In addition, a blank control including the test medium but without the test item was performed. The test item concentrations were analytically verified by using HPLC-UV to be 5.715, 12.43, 25.93, 50.37 and 102.66 mg/L after 48 hours. The test item concentration was thus 91 – 104 % of the nominal at the end of the experimental phase (at the start of the test: 95 –100 of the nominal). Therefore, all biological results are based on nominal concentrations. The suitability of the test system was confirmed by a positive control with the reference substance potassium dichromate (24h EC50 = 1.12 mg/L). All validity criteria of the test guidelines were fulfilled. The mobility of the test animals was recorded after 24 and 48 hours of exposure. As a result, the 48-hour EC50 of the test item was determined to be >100 mg/L in nominal (95 % conf. limits: 91.4 – 331.8 calculated). The 48-hour EC10 was found to be 66.1 mg/L in nominal (95 % conf. limits: 18.7 – 82.5 mg/L).

 

On the basis of the above results, test chemical was considered as non-toxic to aquatic invertebrates at environmental relevant concentrations and hence, considered to be 'not classified' as per the CLP classification criteria.