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Toxicity to birds

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Endpoint:
long-term toxicity to birds: reproduction test
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 206 (Avian Reproduction Test)
Deviations:
no
GLP compliance:
yes
Dose method:
feed
Test organisms (species):
Colinus virginianus
Limit test:
no
Total exposure duration (if not single dose):
22 wk
Remarks:
Ca. 10 weeks pre-production phase, egg-laying phase from week 11 to termination.
No. of animals per sex per dose and/or stage:
20 replicates per treatment, one male/femal pair per replicate.
Control animals:
yes
Nominal and measured doses / concentrations:
0 (control), 80, 200 and 500 mg/kg food
Details on examinations and observations:
Observations including mortality, clinical signs, body weight and food consumption.
Details on reproductive parameters:
Reproduction assessed by parameters including eggs laid per female, eggs damaged, eggshell thicknesses, viable embryos, hatching success.
Duration (if not single dose):
22 wk
Dose descriptor:
NOEC
Effect level:
500 mg/kg diet
Basis for effect:
reproductive parameters
Duration (if not single dose):
22 wk
Dose descriptor:
NOEC
Effect level:
500 mg/kg diet
Basis for effect:
mortality
Remarks:
of adult (parental) birds
Duration (if not single dose):
22 wk
Dose descriptor:
NOEC
Effect level:
500 mg/kg diet
Basis for effect:
signs of toxicity
Remarks:
in 14-day-old offspring
Validity criteria fulfilled:
yes
Conclusions:
The sub-chronic/reproductive NOEC of cloquintocet-mexyl to the bobwhite quail was 500 mg/kg diet, the highest dietary concentration tested.
Executive summary:

The long-term toxicity of cloquintocet-mexyl to birds was studied under GLP according to OECD TG 206.  Cloquintocet-mexyl was administered in the diet to bobwhite quail (27 weeks old at test initiation, body weights 196 to 201 g) for 22 weeks at concentrations of 0 (control), 80, 200 and 500 mg/kg food. There were no treatment-related effects on the survival or behaviour of adult birds or their reproductive performance, or on the hatching success and early development of their offspring. The NOEC was therefore 500 mg cloquintocet-mexyl/kg diet, the highest concentration tested.

Endpoint:
long-term toxicity to birds: reproduction test
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 206 (Avian Reproduction Test)
Deviations:
no
GLP compliance:
yes
Dose method:
feed
Test organisms (species):
Anas platyrhynchos
Limit test:
no
Total exposure duration (if not single dose):
23 wk
Remarks:
Ca. 11 weeks pre-production phase, egg-laying phase from week 12 to termination.
No. of animals per sex per dose and/or stage:
Six replicates per treatment, 2 males + 5 females per replicate.
Control animals:
yes
Nominal and measured doses / concentrations:
0 (control), 80, 200 and 500 mg/kg food
Details on examinations and observations:
Observations including mortality, clinical signs, body weight and food consumption.
Details on reproductive parameters:
Reproduction assessed by parameters including eggs laid per female, eggs damaged, eggshell thicknesses, viable embryos, hatching success.
Duration (if not single dose):
23 wk
Dose descriptor:
NOEC
Effect level:
500 mg/kg diet
Basis for effect:
reproductive parameters
Duration (if not single dose):
23 wk
Dose descriptor:
NOEC
Effect level:
500 mg/kg diet
Basis for effect:
mortality
Remarks:
of adult (parental) birds
Duration (if not single dose):
23 wk
Dose descriptor:
NOEC
Effect level:
500 mg/kg diet
Basis for effect:
signs of toxicity
Remarks:
in 14-day-old offspring
Validity criteria fulfilled:
yes
Conclusions:
The sub-chronic/reproductive NOEC of cloquintocet-mexyl to the mallard duck was 500 mg/kg diet, the highest dietary concentration tested.
Executive summary:

The long-term toxicity of cloquintocet-mexyl to birds was studied under GLP according to OECD TG 206. Cloquintocet-mexyl was administered in the diet to mallard ducks (27 weeks old at test initiation, body weights 935 to 1073 g) for 23 weeks at concentrations of 0 (control), 80, 200 and 500 mg/kg food. There were no treatment-related effects on the survival or behaviour of adult birds or their reproductive performance, or on the hatching success and early development of their offspring. The NOEC was therefore 500 mg cloquintocet-mexyl/kg diet, the highest concentration tested.

Description of key information

Long-term NOEC = 500 mg/kg, mallard duck and bobwhite quail (OECD 206, Johnson 1993 & Johnson 1993b)

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for birds:
500 mg/kg food

Additional information

Cloquintocet-mexyl is of low toxicity to birds, as indicated by the results of the acute toxicity studies. Two GLP compliant guideline studies that are considered to be reliable without restrictions reported LD50 values to mallard duck (Anas platyrhynchos) and bobwhite quail (Colinus virginianus) of 2000 mg/kg body weight (Hakin et al, 1989 and 1990, respectively).

In two further studies (both Hakin et al, 1990), cloquintocet-mexyl administered for 5 days in the diet showed to be non-toxic to birds since LC50 values found in both mallard duck and bobwhite quail were >5200 mg/kg feed.

In two reliable GLP studies performed according to OECD TG 206 (both Johnson, 1993), the dietary administration of up to 500 mg/kg feed over a 22-week period had no effect on adult mallard duck and bobwhite quail or their reproductive performance. Therefore, the NOEC was 500 mg cloquintocet-mexyl/kg feed.

No effects were detected on birds at high exposure levels in the laboratory so it is concluded that cloquintocet-mexyl under normal field use conditions will have no effect on birds. Accordingly, the key value used for this endpoint in the chemical safety report is the long-term NOEC of 500 mg/kg in food.