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Toxicity to birds

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Endpoint:
long-term toxicity to birds
Remarks:
long-term or reproductive testing
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint:
short-term toxicity to birds: dietary toxicity test
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Studies conducted according to sound scientific principles, no GLP nor analytical monitoring.
Qualifier:
no guideline followed
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 223 (Avian Acute Oral Toxicity Test)
Deviations:
not applicable
GLP compliance:
not specified
Dose method:
feed
Analytical monitoring:
no
Vehicle:
yes
Details on preparation and analysis of diet:
DIET PREPARATION

- Description and nutrient analysis of basal diet provided in study report: yes

- Preparation of doses: The test substance and dieldrin (positive control) were dissolved in corn oil in concentrations such that the addition of two parts (by weight) of each solution to 98 parts of the standard game bird starter ration resulted in the logarithmic series of dosage levels defined in Table 2.
Test organisms (species):
other: Anas platyrhynchos (duck) and Colinus virginianus (quail)
Details on test organisms:
- Common name: Mallard duck (Anas platyrhynchos) and bobwhite quail (Colinus virginianus)

- Source: Production flock, Truslow Farms Inc., Chestertown, Maryland

- Age at test initiation: 14 days, both species

- Disease free: yes
Limit test:
no
Total exposure duration (if not single dose):
5 d
Post exposure observation period:
3 days
No. of animals per sex per dose and/or stage:
5 pens per treatment, 5 birds per pen.
Control animals:
yes, plain diet
Nominal and measured doses / concentrations:
See Table 1.
Details on test conditions:
ACCLIMATION

- Acclimation period: the eggs were incubated in a Chick master (Model 52E) for 23 days (quails) and 25 days (ducks), upon hatching the chicks were placed in Beacon (Model B755) battery broodes until they were 14 days of age.

- Acclimation conditions (same as test or not): temperature was the same (ca. 99.0 degF)

- Feeding: basal diet was Truslow Farms' game bird starter ration, available ad libitum

- Health (any disease or mortality observed): none reported

- Fasting period before study: none


FEED WITHHOLDING PERIOD BEFORE DOSING

- No. of days: none


PEN SIZE AND CONSTRUCTION MATERIALS

- Caging: group


NO. OF BIRDS PER REPLICATE

- For negative control: 10

- For vehicle control: 10

- For treated: 10


NO. OF REPLICATES PER GROUP

- For negative control: 5

- For vehicle control: 1

- For treated: 1


TEST CONDITIONS (range, mean, SD as applicable)

- Temperature:

- Brooder temperature: ca. 99 degF
Details on examinations and observations:
MORTALITY / CLINICAL SIGNS

- Time schedule for examinations: daily


BODY WEIGHT

- Time schedule for examinations: beginning and end of test.



FOOD CONSUMPTION (if feeding study)

- Time schedule for examinations: daily
Reference substance (positive control):
yes
Remarks:
dieldrin
Duration (if not single dose):
5 d
Dose descriptor:
LC50
Effect level:
> 10 000 other: ppm
Conc. / dose based on:
other: nominal conc. of test material
Basis for effect:
mortality
Remarks on result:
other: bobwhite quail and mallard duck
Mortality and sub-lethal effects:
For details on cumulative mortality and sub-lethal effects see Tables 2 and 3.

MORTALITY: 20% bobwhite quail, 0% mallard duck


BODY WEIGHT

- Results: The bobwhite quail suffered a decrease in body weight gain, no statistical analysis provided. No effects were seen for in the duck test. See Tables 2 and 3.


FOOD CONSUMPTION

- Results: The bobwhite quail suffered a decrease in food consumption, no statistical analysis provided. No effects were seen for in the duck test. See Tables 2 and 3.
Results with reference substance (positive control):
BOBWHITE QUAIL:

- Results with reference substance valid? yes

- Relevant effect levels: LC50 = 31 ppm (95% confidence limits: 24-39 ppm)

- Other:


MALLARD DUCK:

- Results with reference substance valid? yes

- Relevant effect levels: LC50 = 97 ppm (95% confidence limits: 69-135 ppm).

- Other: There was a dose-related suppression in body weight gain and food consumption. At 68 ppm dosage level, only hyperexcitability was observed prior to death. The following symptoms of toxicity were observed at 100, 147, 215 and 316 ppm: lack of coordination, depression, loss of the righting relfex, rigidly extended legs and necks, and salivation.
Reported statistics and error estimates:
Mortality was analysed statistically by the method of Litchifield J T and Wilcoxon F J (1949) Pharmacol. Exptl. Therap. 96: 99

Table 2. Mortality, average body weight (per pen) and total food consumption (during the 5 d exposure period) for the bobwhite quail.

 Nominal concentration (ppm)     Mortality (%)     Average body weight (g)     Total estimated food consumption (g)   
 day 0  day 8
 0  0 30  46  530
 464  0  25  38  500
 1,000  0  27  44  525
 2,150  0  25  37  575
 4,640  0  25  38  675
 10,000  20  25  30  475

Table 3. Mortality, average body weight (per treatment) and total food consumption (during the 5 day exposure) for the mallard duck.

 Nominal concentration (ppm)     Mortality (%)     Average body weight (g)   Total estimated food consumption (g)   
 day 0  day 8
 0  0  165  329  4,580
 464  0  185  395  4,400
 1,000  0  185  390  4,425
 2,150  0  190  385  5,100
 4,640  0  190  405  3,890
 10,000  0  175  370  3,475
Validity criteria fulfilled:
yes
Conclusions:
A 5 day LC50 value equivalent to >10,000 ppm (expressed as nominal concentration in the diet) has been determined for the effects of the test substance on mortality of Mallard duck and Bobwhite quail.
Endpoint:
short-term toxicity to birds: acute oral toxicity test
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The result was obtained from a collection of reliable data which has been subject to peer-review and in which the original data sources are traceable.
Qualifier:
no guideline available
Principles of method if other than guideline:
Method: The birds were given a single oral dose via capsule, then observed for 14 days.
GLP compliance:
not specified
Dose method:
capsule
Analytical monitoring:
not specified
Vehicle:
not specified
Test organisms (species):
Anas platyrhynchos
Limit test:
no
Total exposure duration (if not single dose):
14 d
Control animals:
yes
Reference substance (positive control):
not specified
Duration (if not single dose):
14 d
Dose descriptor:
LD50
Effect level:
> 4 640 mg/kg bw
Basis for effect:
mortality
Validity criteria fulfilled:
not specified
Endpoint:
short-term toxicity to birds: acute oral toxicity test
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
The result was obtained from a collection of reliable data which has been subject to peer-review and in which the original data sources are traceable.
Qualifier:
no guideline followed
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 223 (Avian Acute Oral Toxicity Test)
Deviations:
not applicable
GLP compliance:
not specified
Dose method:
feed
Analytical monitoring:
not specified
Vehicle:
no
Test organisms (species):
other: Gallus domesticus
Details on test organisms:
TEST ORGANISM

- Common name: chicken
Limit test:
no
Total exposure duration (if not single dose):
21 d
Control animals:
not specified
Reference substance (positive control):
not specified
Duration (if not single dose):
21 d
Dose descriptor:
LD50
Effect level:
201 000 other: ppm
Conc. / dose based on:
test mat.
Basis for effect:
mortality
Duration (if not single dose):
21 d
Dose descriptor:
NOEC
Effect level:
200 000 other: ppm
Conc. / dose based on:
test mat.
Basis for effect:
mortality
Further details on results:
Mortality was observed at lower concentrations.

The US EPA is a peer reviewed online database source for ecotoxicological studies conducted globally. While full details on the study are not reported, the database does provide an indication of the study that was conducted. In this case the study is only supporting therefore full details are not required.

Validity criteria fulfilled:
not specified
Conclusions:
A reliable 21 day LD50 value of 201,000 ppm has been determined for the effects of decanol on the mortality of the bird Gallus domesticus. Full details of the study are not available.

Description of key information

Short-term: LC50 (5-d) >10,000 ppm A. platyrhynchos (duck) and C. virginianus (quail).

Long term: In accordance with Column 2 of REACH Annex X the study does not need to be conducted, based on the mammalian data available.

Key value for chemical safety assessment

Additional information

Only short term oral toxicity data to birds exists:

 A 5-day LC50 value equivalent to >10,000 ppm (expressed as nominal concentration in the diet) has been determined for the effects of the test substance on mortality of Anas platyrhynchos (mallard duck) and Colinus virginianus (bobwhite quail) [Truslow Farms, 1975].

A 14-d LD50 value of 4640 mg/kg bw has been determined for the effects of the test substance on Anas platyrhynchos [Office of Pesticide Programs, 1995].

A 21-d LD50 value of 201000 ppm and a NOEC value of 201000 ppm have been determined for the effects of the test substance on Anas platyrhynchos [Yoshida M, Hoshii H, 1971].

However none have been selected as key since ECHA (2008, Guidance on information requirements and chemical safety assessment Part B: Hazard Assessment May 2008, version 1.1) reads: "due to poor correlation between short and long term effects, only long term studies are considered suitable for CSA purposes".

 

Long-term toxicity

In accordance with Column 2 of REACH Annex X, studies on long-term or reproductive toxicity to birds (required in section 9.6.1) do not need to be conducted due to the existence of mammalian data demonstrating no long term systemic effects to higher organisms. Secondary poisoning assessment is not required for this substance due to its expected low bioconcentration factor and lack of systemic effects in mammals.