Reaction product of alkylarylsulphonic acid and cycloaliphatic amine

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not applicable

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: meets generally accepted scientific standards, well-documented, and acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

other: Methods of Acute Toxicity Tests with Fish, Macroinvertebrates, and Amphibians" (USEPA, 1975

Deviations:

no

Remarks:

Not specified in report

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

Deionized water was used in the preparation of all stock solutions.

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnids (Daphnia magna) first instar < 24 hours old. The daphnia used in the test were cultured at the testing facilities, and the adult daphnia were fed a suspension of trout chow and alfalfa daily until 24 hours prior to testing.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

225 ppm as CaCO3

Test temperature:

19-20C

pH:

8.1 in the control, 8.3 (100mg/L AMP), 8.9 (320 mg/L AMP), and 9.4 (1000 mg/L AMP)

Dissolved oxygen:

Dissolved oxygen levels ranging from 8.3 mg/L in the control at study start, and levels of 8.5 (control), 8.5 (100mg/L AMP), 8.6 (320 mg/L AMP), and 8.6 mg/L O2 (1000 mg/L AMP) at 48 hours.

Nominal and measured concentrations:

Nominal- 0, 100, 180, 320, 560, and 1000 mg/L AMP-95

Details on test conditions:

Daphnias (Daphnia magna) first instar < 24 hours old. Test conditions were a temperature range of 19-20C, and a photoperiod of 16 hours light/ 8 hour dark photcycle. Test solution (200mL) was placed in 250mL beakers, and ten daphnias were added per test solution.

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

193 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% CL: 100-320 mg/L

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

240 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% CL: 212-272 mg/L

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

There was no additional data provided on the results of the range-finding study referenced in the methods section.

Reported statistics and error estimates:

A computerized program calculated the LC50 for Daphnia based on the Probit dose-response model.

Not applicable

Validity criteria fulfilled:

not specified

Conclusions:

The 48-hour Daphnia magna LC50 was calculated to be 193 mg/L.

Executive summary:

AMP-95 (P-2031, 2-amino-2-methyl-l-propanol), lot number 216 (AMP-94.31%, Water 5.69%, NVM 0.0004%, Neutral Eq. 94.68), was tested for the acute t toxicity effects on daphnias. The 24 and 48 hr LC50 and "no effect" levels were determined by ABC Laboratories, Inc., Columbia, Missouri. Test Conditions-daphnias (Daphnia magna) first instar ≤24 hr old. Test temperature 19-20C. Photoperiodicity 16 hr day light. 200 ml test solution in 250 ml beakers. Ten daphnias per test solution. The AMP-95 concentrations were tested in duplicate at 0, 100, 180, 320, 560 and 1000 mg/liter (ppm). Results- There was no significant changes in the water quality parameters except an increase in pH at the ≥320 mg/l concentration. The estimated LC50 at 24 hr was 240 (212-272) mg/liter and at 48 hr was 193 (100-320) mg/liter (95 percent confidence limits are in parenthesis). The 48 hr “no effect” level was 100 mg/liter.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A well documented study, but the exposure duration is shorter than the guideline requires

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

exposure duration is 24h and not 48h

GLP compliance:

not specified

Analytical monitoring:

no

Details on sampling:

- Concentrations: 5000, 2000, 1000, 100, 10 mg/L
- Sampling method: confirmation of stock solution but not of test concentrations
- Sample storage conditions before analysis: no data

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Controls: potassium dichromate

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: daphnia
- Strain: Straus
- Source: in laboratory breed
- Age at study initiation: >3h, <24h
- Method of breeding: adult animals were cultivated in 4L glass vessels at 21C. The medium was changed once per week. The medium was synthetic water according to DIN 38 412 Part 11. Fed twice daily with algae (Scenedesmus supspicatus).
- Feeding during test: no

ACCLIMATION
- Acclimation period: in house culture and culture medium and test dilution medium are the same

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

24 h

Hardness:

synthetic water according to DIN 38 412 Part 11

Test temperature:

21C

pH:

synthetic water according to DIN 38 412 Part 11

Dissolved oxygen:

not reported

Nominal and measured concentrations:

Nominal concentrations - 1000, 100, 10 mg/L and control in a study conducted on March 7, 1983; and 5000 and 2000 mg/L and a control in a study conducted on March 22, 1983.
No measured concentrations

Details on test conditions:

TEST SYSTEM
- Test vessel: glass
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass, 100 mL
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per positive control (replicates): 2
- Biomass loading rate: no data

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: synthetic water according to DIN 38 412 Part 11
- Culture medium different from test medium: no, they are the same
- Intervals of water quality measurement: no data

OTHER TEST CONDITIONS
- Light intensity: dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mobility at 24 hours

Reference substance (positive control):

yes

Remarks:

1.5 mg/L potassium dichromate

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

>= 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

10% immobilization in blank control in 3 concentration test conducted on March 7, 1983
15% immobilization at 10 mg/L
5% immobilization at 100 mg/L
35% immobilization at 1000 mg/L

0% immobilization in blank control in 2 concentration test conducted on March 22, 1983
0% immobilization at 2000 mg/L
10% immobilization at 5000 mg/L

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Mortality: 100% at 1.5 mg/L in both tests conducted on March 7 and on March 22, 1983
- EC50/LC50: expected to be in the range of 0.6 and 2.1 mg/L; suggesting that the daphnids used in this study were at least as sensitive and perhaps more sensitive than anticipated for this species.

Validity criteria fulfilled:

yes

Remarks:

except exposure duration less than the required 48h

Conclusions:

This well-documented, but short-duration study provides weight of evidence that toluene-4-sulphonic acid has a relatively low toxicity to daphnids, with an EC50 > 1000 mg/L (equivalent to >650 mg/L active substance).

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not applicable

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: meets generally accepted scientific standards, well-documented, and acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 850.1045 (Penaeid Acute Toxicity Test)

Deviations:

yes

Remarks:

The test species is a brown shrimp from the North Sea. No analytical verification of the test concentrations was made.

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):Not applicable

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

Each test solution was prepared by introducing the appropriate weight of test material into 10 litres of clean seawater in the exposure vessel.

Test organisms (species):

Crangon crangon

Details on test organisms:

TEST ORGANISM- Common name: Brown shrimp- Source: Tor Bay- Weight at study initiation (mean and range, SD): average weight 1.9g- Length at study initiation (length definition, mean, range and SD): average length 49.8 mmACCLIMATION- Acclimation period: 5 days on site fed with a specific diet and a minimum of 3 days at the test temperature.

Test type:

semi-static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

No data

Test temperature:

14.7-15.8C

pH:

8.0-10.1

Dissolved oxygen:

7.2-8.4 mg/L

Salinity:

34.86-34.90 o/oo

Nominal and measured concentrations:

Nominal- 0, 56, 100, 320, and 560 mg/L

Details on test conditions:

Concentrations of AMP-95 tested were 0, 56, 100, 320, and 560 mg/L under semi-static conditions for 96 hours. The 18L glass vessel was folled with 10L of the test solution, and 20 brown shrimp were added to each vessel after an on-site acclimation period of 5 days on a specially-prepared diet. Food was withheld during the test. The test solution was comprised of local filtered seawater (pH=8.10-8.16, salinity 34.86-34.90 o/oo), and was maintained within a temperature range of 14.7-15.8C. The solutions were aerated with compressed air and dissolved O2 ranged from 7.2-8.4 mg/L. The pH range during the test was 8.0-10.1. Hardness was not reported.

Reference substance (positive control):

no

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

241 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% CI: 17.8-292 mg/L

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

179 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% CL: 98.2-329 mg/L

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

179 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% CL: 98.2-329 mg/L

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

179 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% CL: 98.2-329 mg/L

Details on results:

The control mortality was 0% at 96 hours.

Results with reference substance (positive control):

Not applicable

Validity criteria fulfilled:

not specified

Conclusions:

The Crangon crangon 96 hour LC50 was 179 mg/L.

Executive summary:

A sample of a biocide, 2 Amino-2-Methyl-Propanol, (AMP 95), (Brixham Test Substance No K349), was submitted by CEGB for

aquatic toxicity testing. The species tested were the brown shrimp (Crangon crangon) and the plaice (Pleuronectes platessa). Each test solution was prepared by introducing the appropriate weight of the test material into 10 litres of clean seawater in the exposure vessel. The test organisms were than added to the seawater. Certificates of the test results are given and the cumulative mortalities in each concentration have been tabulated. The shrimp test was carried out during the period 15-19 August 1983 and the plaice test during the period 22-26 August 1983. The COD, TOC, and BOD of the product were also measured by standard methods and are reported below. The study numbers were K349/A and K349/B. All records and original data relevant to these studies are stored in the Brixham archive. Conclusion: Cumulative percentage mortality.

Description of key information

Short term toxicity studies on invertebrates on AMP show EC50 values of 193 mg/L in fresh water and 179 mg/L in salt water. The 24 h EC50 for daphnia in a test with PTSA is > 650 mg/L.

For the substance the EC50 is set at 193 mg/L in a worst case assumption. No value for salt water is derived in absence of data on PTSA.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

193 mg/L

Additional information

The rationale for read-across can be found in the document attached in section 13.