Benzyldimethyl(octadecyl)ammonium chloride

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From February 03, 1995 to March 31, 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

Refer to the section 13 of IUCLID dataset for details on the read across justification. The algae study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Version / remarks:

Cited as OECD Guideline 202, part 2 (Daphnia sp., Reproduction Test)

Deviations:

yes

Remarks:

due to analytical limitations, no concentrations tested could be analysed. Instead a solution of 1 mg/L was used under the same conditions of the test to prove stability of test concentration.

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

Strain / Clone: Daphnia magna clone V
Source: Daphnia magna culture kept as a continuous stock at the test facility. Clone V was originally obtained from the RIZA Lelystad, NL

Breeding method: The stock was kept in 3 L beakers containing approximately 2.5 L of culture medium. The maximum number of daphnids per test
vessel was 150 for the animals being 0 to 6 d old and 80 for the animals being older than 6 d. The culture medium was batchwise refreshed at least twice a week. During culturing the animals were fed six times a week with a chlorella-suspension. The daphnid culture was kept at 19-21ºC, 8 h dark and 16 h light and light intensity of approximately 1000 lux.
Kind of food: Chlorella pyrenoidosa suspension
Feeding frequency: Six times a week
Pretreatment: No
Feeding of animals during test: Yes,
Day food (µL)
0 15
1 15
2 20
3 30
4 40
5 50
6 60
7 70
8 80
9 90
10-20 100

Test type:

semi-static

Water media type:

freshwater

Total exposure duration:

21 d

Nominal and measured concentrations:

Nominal: 0, 0.0031, 0.0063, 0.0125, 0.025, 0.05, 0.1 or 0.2 mg/L

Details on test conditions:

The study was performed according to the draft OECD test guideline 202, part II: Daphnia, reproduction test, draft 6/93 with some modifications which were:
- The composition of the dilution water was according to a correction of the guideline.
- The food amount was not recalculated into TOC-content.
- The number of offspring and the number of parent animals was not counted daily, but on the Days of renewal of the test solutions only.
- The number of test vessels and the number of animals per test vessel.
- The number of offspring was tested in a two-sided Dunnett-test. 20 Daphnia magna per concentration were exposed to 0, 0.0031, 0.0063, 0.0125, 0.025, 0.05, 0.1 or 0.2 mg/L of the test substance for 22d under semi-static conditions. There was no analytical method available to analyse the very low concentrations used in this test. All values given are therefore nominal concentrations. The number of living offspring per parent animal per d is assessed as is the mortality of the parent animals. A NOEC and LOEC was determined for reproduction and for mortality of the parent animals. In order to prove the stability of the test substance a stability study was performed under test conditions at a concentration of 1 mg/L. Percentage recovery ranged between 98 and 107%.

Reference substance (positive control):

no

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

0.013 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

0.025 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

0.025 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

0.05 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Details on results:

NOEC mortality parent animals = 0.025 mg/L
LOEC mortality parent animals = 0.05  mg/L. 
At the next higher concentration, 0.1 mg/L all parent animals died within 48 h. Therefore there was no significant inhibition nor a stimulation effect observed at all concentrations tested.  The NOEC and LOEC for reproduction therefore amounted to respectively 0.05 mg/L and 0.1 mg/L.
Based on active substance:
NOEC mortality parent animals = 0.0125 mg a.i./L.
LOEC mortality parent animals = 0.025  mg a.i./L. 
NOEC (reproduction) = 0.025 mg a.i./L.
LOEC (reproduction) = 0.05  mg a.i./L. 
- Conclusion: 
No effects on reproduction were observed at the highest level which could be tested. The 48h-NOEC and LOEC are about a factor three higher than the 48h-NOEC and LOEC from the acute daphnia toxicity study. (NOEC 0.0125 vs 0.0048 mg a.i./L; LOEC 0.025 vs 0.0075 mg a.i./L). Although somewhat high, it is considered to be caused by normal biological variation. Besides, the NOEC and LOEC in this study are defined by a statistical significant difference of the test group to the control. Although at 0.006 mg a.i./L cumulative mortality reached 40% compared to 16% in the control, but this did not reach statistical significant level. The 48h-EC100 is in both studies the same: 0.05 mg a.i./L Irrespective of the differences in acute toxicity, this study demonstrates that reproduction capacity only appears subsequent to acute toxicity, and that the chronic NOEL therefore does not differ from the acute NOEL.

Results with reference substance (positive control):

-

Reported statistics and error estimates:

Established on statistical evaluation of difference to controls

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the 21d NOEC and LOEC values, based on mortality of parent animals, were determined to be 0.0125 mg a.i./L and 0.025 mg a.i./L respectively. The NOEC and LOEC for reproduction were determined at 0.025 and 0.05 mg a.i./L.

Executive summary:

A study was conducted to determine the long-term toxicity of the read across substance, C12-16 ADBAC (active: 50.5%), to aquatic invertebrates according to OECD Guideline 211, in compliance with GLP. Twenty daphnids per concentration were exposed to 0, 0.0031, 0.0063, 0.0125, 0.025, 0.05, 0.1 or 0.2 mg a.i./L of test substance for 21 days under semi-static conditions. There was no analytical method available to analyse the very low concentrations used in the study. All values given were therefore nominal. The number of living offspring per parent per day was assessed, as well as the mortality of the parent animals. The NOEC and LOEC were determined for reproduction and mortality of the parent animals. In order to prove the stability of the test substance, a study was performed under test conditions at a concentration of 1 mg/L. Percentage recovery ranged between 98 and 107%. Under the study conditions, the 21d NOEC and LOEC values, based on mortality of parent animals were determined to be 0.0125 mg a.i./L and 0.025 mg a.i./L respectively. At the next higher concentration, 0.05 mg a.i./L, all parent animals died within 48 h. Therefore, there was no significant inhibition nor a stimulation effect observed at all tested concentrations. The NOEC and LOEC for reproduction were therefore determined at 0.025 and 0.05 mg a.i./L respectively (Mark, 1995). Based on the results of the read across study, similar NOEC and LOEC values can be expected for the test substance, C18 ADBAC, for long-term toxicity to Daphnia.

Description of key information

Based on the results of the read across study, the 21 d NOEC and LOEC values of the test substance, C18 ADBAC for toxicity in Daphnia is considered to be 0.0125 mg a.i./L and 0.025 mg a.i./L (nominal; based on mortality) and at 0.025 and 0.05 mg a.i./L (nominal; based on reproduction) respectively.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.025 mg/L

Additional information

A study was conducted to determine the long-term toxicity of the read across substance, C12-16 ADBAC (active: 50.5%), to aquatic invertebrates according to OECD Guideline 211, in compliance with GLP. Twenty daphnids per concentration were exposed to 0, 0.0031, 0.0063, 0.0125, 0.025, 0.05, 0.1 or 0.2 mg a.i./L of test substance for 21 days under semi-static conditions. There was no analytical method available to analyse the very low concentrations used in the study. All values given were therefore nominal. The number of living offspring per parent per day was assessed, as well as the mortality of the parent animals. The NOEC and LOEC were determined for reproduction and mortality of the parent animals. In order to prove the stability of the test substance, a study was performed under test conditions at a concentration of 1 mg/L. Percentage recovery ranged between 98 and 107%.Under the study conditions, the 21d NOEC and LOEC values, based on mortality of parent animals were determined to be 0.0125 mg a.i./L and 0.025 mg a.i./L respectively. At the next higher concentration, 0.05 mg a.i./L, all parent animals died within 48 h. Therefore, there was no significant inhibition nor a stimulation effect observed at all tested concentrations. The NOEC and LOEC for reproduction were therefore determined at 0.025 and 0.05 mg a.i./L respectively (nominal) (Mark, 1995). Based on the results of the read across study, similar NOEC and LOEC values can be expected for the test substance, C18 ADBAC, for long-term toxicity to Daphnia