Dimethyldioctylammonium chloride

Toxicity to birds

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to birds: acute oral toxicity test

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Not stated

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 223 (Avian Acute Oral Toxicity Test)

Version / remarks:

The study report did not state they followed any guideline, however the study is largely conducted according to these guideline principals

GLP compliance:

not specified

Specific details on test material used for the study:

- Purity: 50% active solution
- Receipt date: 7 November 1973
- Supplier: Lonza Inc.
- Batch number: not stated

Dose method:

feed

Analytical monitoring:

not specified

Vehicle:

no

Details on preparation and analysis of diet:

-Bardac-LF and Dieldrin positive control preparation: the substances were dissolved in edible grade corn oil and incorporated in the ratio such that the concentration of the toxicants, in solution, represented two parts (by weights) of the diet while the standard bird ratio represented ninety-eight parts (by weight) of the final feed ration to be utilised for the test procedure.
-Control: The food was prepared using edible grade corn oil, minus the toxicants and standard bird ration, to produce the same ratios as per the food with the toxicants.

Test organisms (species):

other: Colinus virginianus (bobwhite quail) and Anas platyrhynchos (mallard duck)

Details on test organisms:

- Number of individuals: 60 Bobtail quail (Colinus virginianus) and a similar number of Mallard ducks (Anas platyrhynchos) per toxicant group.
- Age of birds: birds were between 10 and 15 days of age
- Selection of birds: randomly selected for sex

Limit test:

no

Total exposure duration (if not single dose):

5 d

Remarks:

During the 8 day test procedure the test birds recieved diets containing their respective toxicants for the first 5 days, at which time standard bird ration was substituted and fed for an additional 3 days

Post exposure observation period:

3 days observation post dosing

No. of animals per sex per dose and/or stage:

- 10 birds per group (see Table 1 for further details)

Control animals:

yes, plain diet

Nominal and measured doses / concentrations:

Bardac-LF Mallard Ducks - 1,000 - 3,500 ppm
Bardac-LF Bobwhite Quail - 500-5,000 ppm
Dieldrin (postive control) Mallard Ducks - 25-100 ppm
Dieldrin (positive control) Bobwhite Quail - 5 - 50 ppm

Details on test conditions:

- Test set-up: birds were housed in thermostatically controlled quarters
- Acclimation period: duration not specified, during this period birds recieved normal control ration (edible grade oil combined with standard bird ration)
- Test period: feed and water were available ad libitum.

Details on examinations and observations:

- Over the 5 day dosing period and 3 day post exposure period, the birds were examined for:
- body weights at day zero by group
- food consumption, based upon the total condumption per group
- time of death (day) of each bird
- symptoms of toxicity
- percent mortality of each group including the controls

Details on reproductive parameters:

Not measured

Reference substance (positive control):

yes

Remarks:

Dieldrin

Key result

Duration (if not single dose):

8 d

Dose descriptor:

LC50

Remarks:

Bobwhite quail

Effect level:

2 625 mg/kg bw

Conc. / dose based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: ± 208 mg/kg

Key result

Duration (if not single dose):

8 d

Dose descriptor:

LC50

Remarks:

Mallard ducks

Effect level:

> 5 000 mg/kg bw

Conc. / dose based on:

test mat.

Basis for effect:

mortality

Repellency factors (if applicable):

Not applicable

Mortality and sub-lethal effects:

- The mortality rates are presented in Tables 2 and 3 below.
- Bardac-LF has no effect upon mallard ducks at levels up to 5,000 ppm. In Bobtail quail, 1000ppm caused depression in 2 of the 10 birds but cause no fatalities. In higher concentrations from 2,000 up to 5,000 ppm Bardac-LF caused depression and varying rates of death which increased as the toxicant concentration increased.
- Control group mortality rates were 0 for both the Bobwhite Quail and the Mallard Duck

Effects on reproduction:

Not measured

Results with reference substance (positive control):

-The positive control, Dieldrin, caused depression at 25 ppm but no fatalities for Malard ducks. At 35, 40, 50, 70 and 100ppm resulted in depression, feather erection, and sluggish righting reflex and mortality proportional to the dosed concentration. In the Bobwhite quail the 5ppm concentration caused depression, with the 10, 20, 25, 40 and 50 ppm concentrations resulting in depression, sluggish righting reflex, feather erection and varying rates of mortality directly proportional to the toxicant concentration.
- See Tables 4 and 5 for the individual results

Further details on results:

The test substance is considerably less toxic that Dieldrin (the positive control) to both the bobwhite quial and the mallard duck. The LC50 for the mallard duck was 50.08 mg/kg and for bobwhite quail was 17.30 mg/kg.

Reported statistics and error estimates:

Eight day LC50 determinations were estimated in accordance with the methods of Miller and Tainter (Experimental Biology and Medicine, 57, pp 261-264, 1944).

Table 2. Mallard duck mortality after exposure to Bardac-LF

Group	Dietary level (ppm)	Body weight Day 0 (gms)*	Food consumption (gms)**	Death rate								% mortality
				Day 1	Day 2	Day 3	Day 4	Day 5	Day 6	Day 7	Day 8
1	1,000	600	500	0	0	0	0	0	0	0	0	0
2	2,000	620	620	0	0	0	0	0	0	0	0	0
3	3,000	610	500	0	0	0	0	0	0	0	0	0
4	4,000	550	510	0	0	0	0	0	0	0	0	0
5	4,500	570	420	0	0	0	0	0	0	0	0	0
6	5,000	580	650	0	0	0	0	0	0	0	0	0

Table 3. Bobwhite Quail mortality after exposure to Bardac-LF

Group	Dietary level (ppm)**	Body weight Day 0 (gms)*	Food consumption (gms)**	Death rate								% mortality
				Day 1	Day 2	Day 3	Day 4	Day 5	Day 6	Day 7	Day 8
1	1,000	95	70	0	0	0	0	0	0	0	0	0
2	2,000	98	70	0	0	0	0	1	1	0	0	20
3	3,000	100	60	0	0	0	1	1	1	0	0	30
4	4,000	98	55	0	0	0	1	1	2	1	0	50
5	4,500	104	50	0	0	0	2	3	2	1	0	80
6	5,000	102	40	0	0	0	2	4	2	2	-	100

Table 4. Mallard Duck mortality after exposure to the positive control Dieldrin

Group	Dietary level (ppm)	Body weight Day 0 (gms)	Food consumption (gms)	Death rate								% mortality
				Day 1	Day 2	Day 3	Day 4	Day 5	Day 6	Day 7	Day 8
1	25	600	450	0	0	0	0	0	0	0	0	0
2	35	595	440	0	0	1	0	0	1	0	0	20
3	40	598	310	0	1	0	1	1	0	0	0	30
4	50	605	280	0	0	2	1	0	1	0	0	40
5	70	590	200	1	2	1	1	0	1	1	0	70
6	100	594	175	2	1	2	2	1	1	1	-	100

Table 4. Bobwhite Quail mortality after exposure to the positive control Dieldrin

Group	Dietary level (ppm)	Body weight Day 0 (gms)	Food consumption (gms)	Death rate								% mortality
				Day 1	Day 2	Day 3	Day 4	Day 5	Day 6	Day 7	Day 8
1	5	100	50	0	0	0	0	0	0	0	0	0
2	10	100	45	0	0	0	0	1	0	1	0	20
3	20	98	40	0	0	2	1	2	1	0	0	60
4	25	100	35	0	0	2	2	1	2	0	0	70
5	40	98	30	0	2	2	2	1	1	0	0	80
6	50	96	25	0	2	4	1	2	1	-	-	100

* Body weight/cage group

** Food consumption based upon total consumption per pen

Validity criteria fulfilled:

not specified

Conclusions:

The LC50 of C8DAQ (Bardac LF) to bobwhite quail and mallard ducks was 2625 and >5000 mg/kg body weight, rspectively.

Executive summary:

An acute oral toxicity study of the effect of C8DAQ (Bardac LF) on bobwhite quail and mallard ducks was undertaken following the principles of the OECD 223 test guideline. The purity of the test substance was stated as 50%. The test duration was 8 days during which the birds received diets containing the test substance for the first 5 days after which they were fed a standard bird ration for an additional 3 days. The mallard ducks were fed concentrations ranging from 1,000 to 3,500 ppm and the bobwhite quail concentrations between 500 to 5,000 ppm. The LC50 of the test substance to bobwhite quail and mallard duck was calculated at 2625 and >5000 mg/Kg body weight, respectively. It does not appear that the purity of the test substance was taken into account with the LC50 calculations and therefore the actual effect concentrations are expected to be lower.

Reference 2

Endpoint:

short-term toxicity to birds: acute oral toxicity test (LD50-slope)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 May 1977 to 1 July 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 223 (Avian Acute Oral Toxicity Test)

Version / remarks:

This study was carried out prior to adoption of the guideline but largely follows the principals of it.

GLP compliance:

not specified

Specific details on test material used for the study:

- Test material name: Bardac LF
- Batch number: B3909
- Test material appearance: yellow liquid with an ammonia odor
- Date recieved: April 22, 1977
- CAS number: not specified
- Purity: not stated

Dose method:

gavage

Analytical monitoring:

no

Vehicle:

not specified

Details on preparation and analysis of diet:

No details provided

Test organisms (species):

Anas platyrhynchos

Details on test organisms:

- Name: study report states Mallard ducks
- Number of ducks: 60 in total, 30 female and 30 male
- Age of ducks: not less than 16 weeks of age
- Source of ducks: Whistling Wings, Hanover, Illinois

Limit test:

no

Total exposure duration (if not single dose):

14 d

Remarks:

The test material was administered by gavage to each dose level on a g/kg body weight basis, in one single administration.

Post exposure observation period:

The birds were observed for 14 days post exposure.

No. of animals per sex per dose and/or stage:

10 animals per dose group. 5 dosed groups and one sterile water control group.

Control animals:

yes

yes, plain drinking water

Nominal and measured doses / concentrations:

Nominal dosing concentrations - 0.092, 0.28, 0.55, 0.83, 1.80 gm/kg B.W.
Measured dosing concentrations - not measured

Details on test conditions:

- Assignment of birds to groups: randomly assigned, with 5 males and 5 females in each group
- Housing conditions: wire screened pens measuring 230cm x 240 cm x 270cm.
- Feeding: standard laboratory diets (Anthonys duck pellets) and water were provided ad libitum.
- Dosing procedure: test birds were fasted for a period of approximately 15 hours prior to testing.

Details on examinations and observations:

Birds were observed for signs of toxicity and mortality daily for a total of 14 days. At days 0, 7 and 14 body weights were measured. At days 7 and 14 food consumption was measured.

Details on reproductive parameters:

None.

Reference substance (positive control):

no

Key result

Duration (if not single dose):

14 d

Dose descriptor:

other: LD1

Effect level:

0.036 other: gm/kg

Conc. / dose based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: lower limit 0.019, upper limit 0.067 gm/kg

Key result

Duration (if not single dose):

14 d

Dose descriptor:

LD50

Effect level:

0.24 other: gm/kg

Conc. / dose based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Lower limit 0.17 gm/kg, upper limit 3 gm/kg

Duration (if not single dose):

14 d

Dose descriptor:

other: LD99

Effect level:

1.6 other: gm/kg

Conc. / dose based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: lower limit 0.86, upper limit 3 gm/kg

Mortality and sub-lethal effects:

- Abnormal behaviours: were noted for any birds on any day.
- Food consumption: the average food consumption dropped with the dosed concentration (see Table 3).
- Body weights: no obvious differences between the body weights of the birds at the different dosed concentrations (see table 2).

Effects on reproduction:

Not measured

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

LDx determinations were calculated according to Litchfield, J. T., Jr. and Wilcoxon, F., "Simplified Methof Evaluating Dose Effect Experiments", Journal of Pharmacology ad Experiment Therapy, 96, 99-113.

Table 1. Mortality for the acute oral toxicity of Bardac LF in mallard ducks

		Observation day														Total	Percentage
Dose concentration (gm/kg B.W)	Number of birds per group	1	2	3	4	5	6	7	8	9	10	11	12	13	14
0.092	10	1	1	0	0	0	0	0	0	0	0	0	0	1	0	3	30
0.28	10	3	0	0	1	0	0	0	0	0	0	1	0	0	0	5	50
0.55	10	5	1	0	1	0	0	0	0	1	0	0	0	1	0	9	90
0.83	10	10	0	0	0	0	0	0	0	0	0	0	0	0	0	10	100
1.8`	10	10	0	0	0	0	0	0	0	0	0	0	0	0	0	10	100
Control	10	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Table 2. Average body weights of birds over the 14 day duration.

	Average body weight (kg) of female birds			Average body weight (kg) of male birds
Dose concentration (gm/kg B.W)	Test day 0	Test day 7	Test day 14	Test day 0	Test day 7	Test day 14
0.092	1.1	1.2	1.3	1.2	0.9	1.1
0.28	1.0	0.7	N/P	1.1	0.8	1.1
0.55	1.0	0.5	N/P	1.2	0.8	0.7
0.83	1.3	N/P	N/P	1.2	N/P	N/P
1.8	1.1	N/P	N/P	1.1	N/P	N/P
Control	1.0	1.0	1.1	1.1	1.1	1.2

N/P - weights not provided in study report, due to mortality of all or most of the birds in group

Table 3. Weekly food consumption for the acute oral toxicity of Bardac LF in Mallard ducks

	Food Consumption (kg)		Average daily food consumption (gm/bird
Dose concentration (gm/kg B.W)	Week 1	Week 2
0.092	0.5	4.6	42
0.28	0.6	4.0	50
0.55	0	0	0
0.83	0.2	0	0.2
1.8	0.2	0	0.2
Control	5	4.7	65

Validity criteria fulfilled:

not specified

Remarks:

Study was not stated conducted according to Guidelines

Conclusions:

Based on mortality, LD1, LD50 and LD99's for the mallard duck (Anas platyrhynchos) exposed to C8DAQ (Bardac LF) was 0.036 g/kg (0.019 to 0.067 g/kg), 0.24 g/kg (0.17 to 0.34 g/kg), 1.6 g/kg (0.86 to 3.0 g/kg) respectively.

Executive summary:

The acute toxicity of C8DAQ (Bardac LF) to mallard duck (Anas platyrhynchos) was assessed in a study according to the principles of the OECD 223 Guideline. Ducks were dosed in one single dose using a gavage method. Post dosing the ducks were observed for a 14 day period for mortality, and also at day 0, 7 and 14 days for weight and day 7 and 14 for food consumption. Based on mortality, LD1, LD50 and LD99's of 0.036 g/kg (0.019 to 0.067 g/kg), 0.24 g/kg (0.17 to 0.34 g/kg), 1.6 g/kg (0.86 to 3.0 g/kg) were calculated.

Description of key information

For completeness two studies are available for the bird toxicity endpoint and are included in this dossier, although not a data requirement for Annex IX of the REACH Regulation (EC) No 1907/2006. Two reliable (Klimisch 2) studies are available for the test substance, dioctyldimethylammonium chloride (C8DAQ). Both studies are well documented and follow the principles of OECD test guideline 223.

In a reliable study the acute toxicity of the test substance C8DAQ to mallard ducks (Anas platyrhynchos) was assessed via dietary exposure over a 14-day period. A 14-day LD50 (mortality) of 0.24 g/kg (240 mg/kg) was calculated. This study is selected as the Key Study for its reliability and its more conservative LD50 concentration compared to the Gilman (1974) study.

 In a reliable study, the acute toxicity of the test substance (C8DAQ) to mallard ducks (Anas platyrhynchos) and bobwhite quail (Colinus virginianus) was assessed via dietary exposure over an 8-day period. The LC50 to bobwhite quail was calculated as 2,625 mg/kg body weight and to mallard duck was >5,000 mg/kg body weight. The actual effect concentrations may be lower, as it was not apparent from the report if the purity of the test substance (50%) was taken into account when calculating LC50 values.

Key value for chemical safety assessment

Short-term EC50 or LC50 for birds:

0.24 g/kg food