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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Short-term toxicity to fish

The 96-hour LL50 value based on nominal loading rates was > 1000 mg/L loading rate WAF and correspondingly the No Observed Effect Loading rate was 1000 mg/L loading rate WAF (OECD 203 and EU Method C.1).

 

Short-term toxicity to aquatic invertebrates

The 48-hour EL50 for the test material to Daphnia magna based on nominal loading rates was 150 mg/L loading rate filtered WAF with 95 % confidence limits of 130 - 160 mg/L loading rate filtered WAF. The No Observed Effect Loading rate was 100 mg/L loading rate filtered WAF (OECD 202 and EU Method C.2).

 

Long-term toxicity to fish:

The 33-day nominal No Observed Effect Loading Rate (NOELR) reported in an investigation offathead minnowearly life stage was 10 mg/L based on body length and wet weight (OECD 210).

Long-term toxicity to aquatic invertebrates:

Key study

The 21-day nominal No Observed Effect Loading Rate (NOELR) reported in an investigation of Daphnia magna was 45 mg/L based on reproduction and body length (OECD 211 and EU Method C.20).

Supporting study

The 14 and 21 -day EL50 (immobilisation) values, based on the nominal loading rates, for the parental Daphnia generation were calculated to be 48 and 27 mg/L loading rate filtered WAF with 95% confidence limits of 33 -69 mg/L loading rate filtered WAF and 15 -48 mg/L loading rate filtered WAF respectively. The 21 -day EL50 (reproduction) was calculated to be 31 mg/L loading rate filtered WAF with 95% confidence limits of 37 -37 mg/L. The LOEC is considered to be 48 mg/L loading rate filtered WAF on the basis that at this loading there were significant mortalities (immobilisation) observed in the parental generation. The NOEC is considered to be 15 mg/L loading rate filtered WAF on the basis that at this loading rate there were no mortalities (immobilisation) observed in the parental generation and that there were no significant differences between the control and the 15 mg/L loading rate filtered WAF test group in terms of the number of live young produced per adult by day 21 (OECD 211).

 

Toxicity to algae

Key study

Exposure ofRaphidocelis subcapitatato the test item gave EL50 values of 22 mg/L loading rate WAF based on growth rate and 9.7 mg/L loading rate WAF based on yield. The corresponding No Observed Effect Loading Rates were determined to be 4.5 mg/L loading rate WAF based on growth rate and yield. The Lowest Effect Loading Rates were 10 mg/L loading rate WAF based on growth rate and yield(OECD 201 and EU Method C.3).

Supporting study

Exposure of Scenedesmus subspicatus to the test material gave an EbLR50 (72 h) value of 14 mg/L loading rate Water Soluble Fraction (WSF): 95 % confidence limits 13 to 15 mg/L loading rate WSF and an ErLR50 (0-72 h) value of 16 mg/L loading rate WSF: 9 5% confidence limits 15 to 17 mg/L loading rate WSF. The No Observed Effect Loading Rate was found to be 6.25 mg/L loading rate WSF (OECD 201 and EU Method C.3).

Toxicity to microorganisms

The respiration rates of the sludge-associated microbes exposed to the 5 nominal concentrations of test item were 36.9, 31.7, 31.8, 29.5, and 20.2 mg O2/L*hr respectively. The EC50 was calculated to be > 10000 mg/L (OECD 209).

Additional information

Analysis does not identify the entirety of components that are present in solution and, whilst measured effect levels demonstrate exposure of an aquatic species to the test material, these data cannot describe toxicity of the UVCB substance as a whole. The Water Accommodated Fraction (WAF) approach to Investigation of aquatic toxicity ensures that differences in solubility and volatility of constituents within a complex substance are taken into account. Reporting of results in terms of nominal loading rates therefore reflects the composition and chemistry of the UVCB as a whole and is considered more appropriate to exposure/risk assessment.

Short-term toxicity to fish

The key study was performed to assess the acute toxicity of the test material to rainbow trout (Oncorhynchus mykiss). The method followed that described in the OECD Guidelines for Testing of Chemicals (1992) No 203, "Fish, Acute Toxicity Test'' referenced as Method C.l of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC), US CFR Title 40, Part 797, Section 1400 and US EPA Draft Ecological Effects Test Guideline OPPTS 850.1075.

 

Following a preliminary range-finding study fish were exposed, in two groups of ten, to a Water Accommodated Fraction (WAF) of the test material, at a single nominal loading rate of 1000 mg/L for a period of 96 hours under static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the study until termination after 96 hours.

The 96-Hour LL50 based on nominal loading rates was greater than 1000 mg/L loading rate WAF and correspondingly the No Observed Effect Loading rate was 1000 mg/L loading rate WAF. It was considered unnecessary and unrealistic to test at loading rates in excess of 1000 mg/L.

 

Short-term toxicity to aquatic invertebrates

The key study was performed to assess the acute toxicity of the test material to Daphnia magna. The method followed that described in the OECD Guidelines for Testing of Chemicals (1984) No 202, "Daphnia sp, Acute Immobilisation Test and Reproduction Test" referenced as Method C.2 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

 

Following a preliminary range-finding study, twenty daphnids (2 replicates of 10 animals) were exposed to filtered Water Accommodated Fractions (WAFs) of the test material at nominal loading rates of 10, 18, 32, 56, 100, 180, 320, 560 and 1000 mg/L for 48 hours under static test conditions. The number of immobilised Daphnia were recorded after 24 and 48 hours.

 

The 48-Hour EL50 for the test material to Daphnia magna based on nominal loading rates was 150 mg/L loading rate filtered WAF with 95% confidence limits of 130 - 160 mg/L loading rate filtered WAF. The No Observed Effect Loading rate was 100 mg/L loading rate filtered WAF.

Analysis of the test solutions at 0 hours showed the measured concentrations to range from 0.284 to 6.82 mg/L. At 48 hours the measured concentrations were shown to range from 0.178 to 6.28 mg/L. Measured concentrations were based on total peak area. At both 0 and 48 hours increasing measured concentrations were shown with increasing loading rates. Inspection of these results indicated a small decline in measured test concentrations over 48 hours for the 10, 32, 320 and 1000 mg/L loading rates. However, given the very low concentrations determined, it was considered that these slightly lower values were due to analytical variation as a result of measuring multiple peaks.

 

Given that the toxicity cannot be attributed to any one or more of the components in the WAF, but to the mixture as a whole, the results are based on nominal loading rates only.

 

Long-term toxicity to fish

A study was performed to assess the effects of the test item on the early life stages of the fathead minnow (Pimephales promelas). The method followed that described in the OECD Guidelines for Testing of Chemicals (2013) No 210, "Fish, Early-Life Stage Toxicity Test”.

 

Due to the low aqueous solubility and complex nature of the test item for the purposes of the test the test item was prepared as a Water Accommodated Fraction (WAF).

 

Based on the results of a preliminary range-finding test, newly fertilized fathead minnow eggs (four replicates of 20 eggs per group) were exposed to WAFs of the test item for a period of 33 days at a temperature of 23 to 26 ºC under semi-static test conditions. The test solutions were renewed three times per week throughout the test. The test item solutions were prepared by stirring a nominal loading rates of test item (2.2, 4.5, 10, 22 and 45 mg/L) in test water using a magnetic stirrer using a stirring rate such that a vortex was formed to give a dimple at the water surface for 3 hours. After the stirring period the mixtures allowed to stand for 1 hour before the aqueous phases or WAFs were removed by mid-depth siphoning to give the 2.2, 4.5, 10, 22 and 45 mg/L loading rate WAFs.

 

The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were recorded daily until termination of the test (28 days post-hatch). At test termination the length and wet weight of the surviving fish were measured.

 

Chemical analysis of the fresh test preparations on Days 0, 5, 12, 19, 26 and 30 showed measured boron concentrations (corrected for boron concentrations in the control media) ranged from less than the limit of quantification to 0.461 mg boron/L, corresponding to test item concentrations of less than the limit of quantification and 39 mg/L. Chemical analysis of the old test preparations on Days 2, 7, 14, 21, 28 and 33 showed corrected measured boron concentrations ranged from less than the limit of quantification to 0.458 mg boron/L, corresponding of less than the limit of quantification and 39 mg/L. The limit of quantification for boron was determined to be 0.12 mg/L corresponding to test item concentration of 10 mg/L.

 

Given that the toxicity cannot be attributed to a single component or a mixture of components but to the test item as a whole, the results were based on nominal loading rates only.

Exposure of the early-life stages of fathead minnow to the test item gave the following results based on the nominal test concentrations:

Parameter

Endpoint

Concentration (mg/L loading rate WAF)

Number hatched

LL10

> 45

Number hatched

LL20

> 45

Number hatched

LL50

> 45

Number hatched

No Observed Effect Loading Rate

45

Number hatched

Lowest Observed Effect Loading Rate

Not determined

Post-hatch survival

LL10

> 45

Post-hatch survival

LL20

> 45

Post-hatch survival

LL50

> 45

Post-hatch survival

No Observed Effect Loading Rate

45

Post-hatch survival

Lowest Observed Effect Loading Rate

Not determined

Body length

EL10

> 45

Body length

EL20

> 45

Body length

EL50

> 45

Body length

No Observed Effect Loading Rate

10

Body length

Lowest Observed Effect Loading Rate

22

Wet weight

EL10

26

(95% confidence limits 11 to 62)

Wet weight

EL20

> 45

Wet weight

EL50

> 45

Wet weight

No Observed Effect Loading Rate

10

Wet weight

Lowest Observed Effect Loading Rate

22

Long-term toxicity to aquatic invertebrates

 

Key study

The key study was performed to assess the chronic toxicity of the test item to Daphnia magna. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (2012) No 211, "Daphnia magna Reproduction Test" referenced as Method C.20 of Commission Regulation (EC) No. 440/2008.

Due to the low aqueous solubility and complex nature of the test item, for the purposes of the test, the test medium was prepared as Water Accommodated Fractions (WAFs). Based on the results of a preliminary range‑finding test, Daphnia magna were exposed (10 replicates of a single daphnid per group) to a WAF of the test item over a range of nominal loading rates of 4.5, 10, 22, 45 and 100 mg/L for a period of 21 days. The test solutions were renewed three times per week throughout the test. The numbers of live and dead adult Daphnia and young daphnids (live and dead) were determined daily. The Daphnia were fed daily with algal suspension, supplemented with fish food suspension on Days 0, 1, 2 and 3.

Chemical analysis of the fresh test preparations on Days 0, 5, 12 and 19 showed measured boron concentrations (corrected for boron concentrations in the control media) were between 0.037 and 1.2 mg boron/L, corresponding to test item concentrations of 3.1 and 99 mg/L. Chemical analysis of the old test preparations on Days 2, 7, 14 and 21 showed corrected measured boron concentrations were between 0.026 and 1.2 mg boron/L, corresponding to test item concentrations of 2.2 and 99 mg/L.

Given that the toxicity cannot be attributed to a single component or a mixture of components but to the test item as a whole, the results were based on nominal loading rates only. It was considered unnecessary and unrealistic to test at loading rates in excess of 100 mg/L.

Exposure of Daphnia magna to the test item gave the following results based on the nominal loading rates:

Parameter

Endpoint

Concentration (mg/L loading rate WAF)

Immobilisation

EL10

> 100

Immobilisation

EL20

> 100

Immobilisation

EL50

> 100

Immobilisation

No Observed Effect Loading Rate

100

Immobilisation

Lowest Observed Effect Loading Rate

Not determined

Reproduction

EL10

28

(95 % confidence limits 7.4 to 107)

Reproduction

EL20

52

(95 % confidence limits 12 to 223)

Reproduction

EL50

> 100

Reproduction

No Observed Effect Loading Rate

45

Reproduction

Lowest Observed Effect Loading Rate

100

Body length

EL10

71

(95 % confidence limits 33 to 151)

Body length

EL20

> 100

Body length

EL50

> 100

Body length

No Observed Effect Loading Rate

45

Body length

Lowest Observed Effect Loading Rate

100

Supporting study

A study was performed to assess the effect of the test material on the reproduction of Daphnia magna over a 21-day period. The method followed that described in the OECD Guidelines No 211 "Daphnia magna, Reproduction test".

Based on the results of an acute toxicity study, Daphnia magna were exposed (10 replicates of a single daphnid per group) to filtered WAF of the test material over a range of nominal loading rates of 1.5, 4.8, 15, 48, 150 mg/L for a period of 21 days. The test solutions were renewed 3 times per week. The numbers of live and dead adult Daphnia and young daphnids were determined daily. The Daphnia were fed daily with an algal suspension.

 

Analysis of the test loading rates at 0 hours showed the measured concentrations to range from 0.106 to 0.826 mg/L whilst analysis of the old or expired media sampled throughout the study showed measured concentrations to range from less than the limit of quantification of the analytical method to 0.863 mg/L. These results were in-line with the recovery and stability analyses performed on the WAFs which showed the test material to be unstable in both light and dark conditions at the lower test concentrations. On the majority of sampling occasions increasing measured concentrations were shown with increasing loading rates.

Given that the toxicity cannot be attributed to any one or more of the components in the WAF, but to the mixture as a whole, the results are based on nominal loading rates only.

 

The 14 and 21 -day EL50 (immobilisation) values, based on the nominal loading rates, for the parental Daphnia generation were calculated to be 48 and 27 mg/L loading rate filtered WAF with 95% confidence limits of 33 -69 mg/L loading rate filtered WAF and 15 -48 mg/L loading rate filtered WAF respectively.

 

The 21 -day EL50 (reproduction) was calculated to be 31 mg/L loading rate filtered WAF with 95% confidence limits of 37 -37 mg/L.

 

The LOEC is considered to be 48 mg/L loading rate filtered WAF on the basis that at this loading there were significant mortalities (immobilisation) observed in the parental generation.

The NOEC is considered to be 15 mg/L loading rate filtered WAF on the basis that at this loading rate there were no mortalities (immobilisation) observed in the parental generation and that there were no significant differences between the control and the 15 mg/L loading rate filtered WAF test group in terms of the number of live young produced per adult by day 21.

Toxicity to algae

 

Key study

A study was performed to assess the effect of the test item on the growth of the green algaRaphidocelis subcapitata (formerly known as Pseudokirchneriella subcapitata). The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (2006) No 201, "Freshwater Alga and Cyanobacteria, Growth Inhibition Test" and Method C.3 of Commission Regulation (EC) 761/2009.

 

Due to the low aqueous solubility and complex nature of the test item for the purposes of the study the test medium was prepared as a Water Accommodated Fraction (WAF) of the test item.

 

Following a preliminary range-finding test, Raphidocelis subcapitata was exposed to Water Accommodated Fractions (WAFs) of the test item over a range of nominal loading rates of4.5,10,22,45and100 mg/L (three replicate flasks per concentration) for 72 hours, under constant illumination and shaking at a temperature of 24 ± 1 °C.

Samples of the algal populations were removed daily and cell concentrations determined for each control and treatment group, using a Coulter Multisizer Particle Counter.

 

Chemical analysis of the test preparations at 0 hours showed measured boron concentrations (corrected for boron concentrations in the control media) were between 0.034 and 1.0 mg boron/L, corresponding to test item concentrations of 2.9 and 87 mg/L. Chemical analysis of the test preparations at 72 hours showed corrected measured boron concentrations were between 0.060 and 1.2 mg boron/L, corresponding to test item concentrations of 5.0 and 100 mg/L.

Given that the toxicity cannot be attributed to a single component or a mixture of components but to the test item as a whole, the results were based on nominal loading rates only.

Exposure of Raphidocelis subcapitata to the test item gave EL50 values of 22 mg/L loading rate WAF based on growth rate and 9.7 mg/L loading rate WAF based on yield. The corresponding No Observed Effect Loading Rates were determined to be 4.5 mg/L loading rate WAF based on growth rate and yield. The Lowest Effect Loading Rates were 10 mg/L loading rate WAF based on growth rate and yield.

Supporting study

A study was performed to assess the effect of the test material on the growth of the green alga Scenedesmus subspicatus. The method followed that described in the OECD Guidelines for Testing of Chemicals (1984) No 201, "Alga, Growth Inhibition Test" referenced as Method C.3 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

 

Following a preliminary range-finding study, Scenedesmus subspicatus was exposed to Water Soluble Fraction (WSF) of the test material at loading rates of 6.25, 12.5, 25, 50 and 100 mg/L for 72 hours, under constant illumination and shaking at a temperature of 24 +/-1°C. Samples of the algal populations were removed daily and cell concentrations determined for each control and treatment group using a Coulter Multisizer II Particle Counter.

Exposure of Scenedesmus subspicatus to the test material gave an EbLR50 (72 h) value of 14 mg/L loading rate WSF: 95% confidence limits 13 to 15 mg/L loading rate WSF and an ErLR50 (0-72 h) value of 16 mg/L loading rate WSF: 95 % confidence limits 15 to 17 mg/L loading rate WSF. The No Observed Effect Loading Rate was found to be 6.25 mg/L loading rate WSF.

The concentration of the components of the test material being taken into the water by the preparation of a WSF were expected to be low given the low water solubility of the test material. Analysis at 0 and 72 hours showed the measured test concentrations to range from 1 % to 34 % of nominal. The variation in measured concentration followed a concentration dependent effect with higher percentage of nominal concentrations being determined from the lower test concentrations. Due to the limited water solubility of the test material in the test media only a small amount of test material can enter the aqueous phase before the test medium becomes saturated. Whilst the amount which can enter the aqueous phase is constant regardless of the amount of test material present it becomes of proportionately greater significance as the nominal loading rate, ie the amount of test material present, decreases. Therefore the measured test concentration, expressed as a percentage of nominal loading rate increased as the loading rate declined.

Inhibition of sewage sludge micro-organisms

The potential impact of the substance on microbial metabolism, as represented by the consumption of oxygen, was investigated using the "Activated Sludge, Respiration Inhibition Test" as prescribed by OECD (1984) and detailed in WCC Protocol OECD 209 (Expanded Range Procedures). The test was performed on February 15, 1994. The test duration was a 3-h exposure period to the test material followed by up to 10 minutes for the measurement of oxygen consumption. The study design was comprised of 5 nominal exposure concentrations: 1, 10, 100, 1000, and 10000 ppm; a duplicated control group; and an assessment of the sensitivity of the inoculum used in the test to a reference toxicant (3,5 -dichlorophenol).

 

The activated sludge respiration test with test item passed the quality control criteria for an acceptable test. The EC50 calculated for the reference toxicant was 16.2 mg/L, within the acceptable range of 5 to 30 mg/L. The 2 control replicates produced oxygen consumption rates within the required 15% of each other, 33.4 and 33.0 mg O2/L x hour.

The respiration rates of the sludge-associated microbes exposed to the 5 nominal concentrations of the substance were 36.9, 31.7, 31.8, 29.5, and 20.2 mg O2/L*hr respectively. The EC50 was calculated to be greater than 10000 mg/L.