Benzyldimethyl(octadecyl)ammonium chloride

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

key study

Study period:

1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

KL2 due to RA

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:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on test solutions:

Dilution water:
Source: Synthetic medium following NF EN ISO Norm 6341 from prepared from purified tap water (passed through activated charcoal and exchange resin and filtered at 0.22 µm)
Ca / Mg ratio: 4
Na / K ratio: 10
Oxygen content: « saturation »
Holding water different from dilution water: Yes, Elendt M7 supplemented with algae (specified as “Raphidocelis subcapitata”)

Test organisms (species):

Daphnia magna

Details on test organisms:

Strain: 5 (A) CAL laboratory culture
Age: <24 h
Breeding method: Clone, adults separated from juveniles by sieving
Kind of food: Algae (specified as “Raphidocelis subcapitata”)
Feeding of animals during test: No

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

ca. 20°C

Dissolved oxygen:

saturation

Salinity:

Ca / Mg ratio: 4
Na / K ratio: 10

Nominal and measured concentrations:

Nominal: 0, 0,0095, 0,015, 0,024, 0,039, 0,063 and 0.01 mg/L

Details on test conditions:

- Daphnids were exposed in a static test to 0, 0,0095, 0,015, 0,024, 0,039, 0,063 and 0.01 mg/L test substance, using 2 times 10 dahnids per concentration. - Analytical control at the end of the exposure demontrated that concentration levels remained constant during the exposure time of the study. However, concentrations measured differed from 62% at 0.015 mg/L, increasing with the increase of concentration to 97 and 96% for 0.063 and 0.1mg/L. Concentrations for the lower levels could not be analysed, as they were below the analytical detection limit of 7.3 µg/L. All concentrations given relate to the test substance as tested.
- The concentration-response relationship appears to be typical for this type of substance. The study can be considered as valid despite a few missing details (e.g. detail of volume of solution used, some information on the dilution water).

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.016 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

0.005 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

48h-EC50 = 0.032 mg/L - 95% confidence levels 0.019 - 0.051 mg/L as nominal concentration.

Based on active substance:
48h-NOEC = 0.0048 mg a.i./L
48h-LOEC = 0.0075 mg a.i./L
48h-EC50 = 0.016 mg a.i./L
48h-EC100= 0.05 mg a.i./L

Validity criteria fulfilled:

yes

Conclusions:

Based on the results of the read across study, the 48 h EC50 and NOEC values of the test substance are considered to be at 0.016 mg a.i./L and 0.0048 mg a.i./L (nominal) respectively.

Executive summary:

A study was conducted to determine the short-term toxicity to aquatic invertebrates of the read across substance, C12-16 ADBAC (active: 50.58%), according to EU Method C.2, in compliance with GLP. Daphnia magna were exposed in a static test to nominal concentrations of 0, 0.0095, 0.015, 0.024, 0.039, 0.063 and 0.1 mg/L test substance, using 20 daphnids per concentration. Mobility was monitored throughout the experiment. Analytical dose verification was performed. Analytical control at the end of the exposure demonstrated that concentrations remained constant throughout the exposure period. However, measured concentrations differed by 62% at 0.015 mg/L, increasing to 97 and 96% at 0.063 and 0.1 mg/L. Concentrations for the lower levels could not be analysed as they were below the detection limit of 7.3 µg/L. Under the conditions of the study, the 48 h EC50 and NOEC were determined to be at 0.016 mg a.i./L and 0.0048 mg a.i./L (nominal) respectively (Thiebaud, 1999). Based on the results of the read across study, similar the 48 h EC50 and NOEC values can be considered for the test substance, C18 ADBAC, for short-term toxicity to aquatic invertebrates.

Description of key information

Based on the results of the read across study, the 48 h EC50 and NOEC of the test substance, C18 ADBAC, for toxicity to Daphnia magna is considered to be 0.016 mg a.i./L and 0.0048 mg a.i./L (nominal) respectively.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.016 mg/L

Additional information

A study was conducted to determine the short-term toxicity to aquatic invertebrates of the read across substance, C12-16 ADBAC (active: 50.58%), according to EU Method C.2, in compliance with GLP. Daphnia magna were exposed in a static test to nominal concentrations of 0, 0.0095, 0.015, 0.024, 0.039, 0.063 and 0.1 mg/L test substance, using 20 daphnids per concentration. Mobility was monitored throughout the experiment. Analytical dose verification was performed. Analytical control at the end of the exposure demonstrated that concentrations remained constant throughout the exposure period. However, measured concentrations differed by 62% at 0.015 mg/L, increasing to 97 and 96% at 0.063 and 0.1 mg/L. Concentrations for the lower levels could not be analysed as they were below the detection limit of 7.3 µg/L. Under the conditions of the study, the 48 h EC50 and NOEC were determined to be at 0.016 mg a.i./L and 0.0048 mg a.i./L (nominal) respectively (Thiebaud, 1999). Based on the results of the read across study, similar the 48 h EC50 and NOEC values can be considered for the test substance, C18 ADBAC, for short-term toxicity to aquatic invertebrates.