cis-4-[3-(p-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine

Toxicity to birds

Link to relevant study record(s)

Reference

Endpoint:

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

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08.11.1999- 20.01.2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Guideline:

EPA OPP 71-1 (Avian Acute Oral Toxicity Test)

GLP compliance:

yes

Specific details on test material used for the study:

Fenpropimorph (Reg. No. 108 406); batch no. N 103; purity: 96.6%

Analytical monitoring:

yes

Vehicle:

yes

Details on preparation and analysis of diet:

Concentration control of feed samples were performed using HPLC with
external calibration

Test organisms (species):

Colinus virginianus

Details on test organisms:

TEST ORGANISM
- Common name: Bobwhite quail
- Source: Morris Hatchery Inc., Goulds (Maimi), Florida 33170-5399, USA
- Age at test initiation: approx. 6 months at study start;
before their first egg-Iaying; visually indistinguishable from wild birds
- Weight at test initiation (mean and range, SD):
- Sexes used: mixed - mala and female birds (determination due to coloration of plumage at that age)
- Disease free: yes; no medical treatment
- Kept according to standard practices: yes

Limit test:

no

Total exposure duration (if not single dose):

14 d

Remarks:

Birds treated once administering the test substance in a carrier (aequeous CMC dispersion) by gavage into the crop (5 males / 5 females per dose group). 14 days observation period.

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

5 males / 5 females per dose group

Control animals:

yes, concurrent vehicle

Nominal and measured doses / concentrations:

0 (carrier control), 500, 1000, 2000 mg a.s./kg b.w. (nominal);
The analytically detected concentrations were between 96.7% and 98.6% of the nominal concentrations. Hence results confirm the theoretical values.

Details on test conditions:

ACCLIMATION
- Feeding: commercial quail diet: "Ssniff" experimental diet, special mixture for quail in meat form, Ssniff Spezialitäten GmbH, Soest, Germany;
Drinking water: minicipal water ad libitum throughout maintanance and study
- Health (any disease or mortality observed): Healthy, no medical treatment
- Fasting period before study: Birds fasted 15h - 20 h before administration of the test substance

FEED WITHHOLDING PERIOD BEFORE DOSING
- No. of hours: 15h - 20 h

PEN SIZE AND CONSTRUCTION MATERIALS
- Description: stainless steel wire mesh (0.59 x 0.45 x 0.26m)
- Floor covering: wire mesh floors, mesh size 10 x 15 mm
- Caging: group of 5 birds; male and female were separated


TEST CONDITIONS (range, mean, SD as applicable)
- Temperature: 21°C ± 2°C
- Relative humidity (%): 35% - 70%
- Photoperiod: 10:14 hours light : dark

RANGE FINDING STUDY: No

Key result

Duration (if not single dose):

14 d

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Conc. / dose based on:

act. ingr.

Basis for effect:

mortality

Duration (if not single dose):

14 d

Dose descriptor:

NOEL

Effect level:

1 000 mg/kg bw

Conc. / dose based on:

act. ingr.

Basis for effect:

mortality

Further details on results:

Analytical measurements: The concentration control analysis was performed for all dose levels. The analytically detected concentrations were between 96.7% and 98.6% of the nominal concentrations. Hence results confirm the theoretical values.


Biological results: No mortality occurred in any of the dose groups. 4 hours after the application transiently soft faeces were observed in all dose groups, but not in the control group. This effect was, however, not considered to be adverse. The feed uptake in the first week after application was reduced in the group dosed with 2000 mg a.s./kg b.w.. In the second week of the study no test substance-related impairment of feed uptake in comparison to the control was observed in any of the dose groups. There was no statistically significant test substance related reduction of the body weights in any of the dose groups at study termination. Body weight was however reduced in the females of dose group 2000 mg a.s./kg b.w.

Reported statistics and error estimates:

One-way analysis (ANOVA) followed by Dunnett's test

Table 1:  Acute toxicity of Fenpropimorph to the bobwhite quail (Colinus virginianus)
Mortality	Dose [mg a.s./kg b.w.]
Highest dose causing no compound-related mortality	2000
LD50 (14 d)	> 2000
NOEL (14 d)	1000

Conclusions:

In the acute toxicity test (single-dose oral application) of Fenpropimorph to the bobwhite quail the LDso (14 d) was greater than 2000 mg a.s./kg b.w., the highest concentration tested.
The NOEL was found to be 1000 mg as. /kg b.w.

Description of key information

Fenpropimorph was tested on mallard ducks (Anas platyrhynchos) and bobwhite quails (Colinus virginianus). The studies performed cover a broad range of biological endpoints, such as mortality, signs of toxicity, feed consumption, body weight, post-mortem examinations and various reproduction parameters. LD₅₀ was determined to be > 2000 mg a.s./kg body weight (single dose application) and LC₅₀ > 5000 mg a.s./kg diet (dietary feeding test). Two long-term avian reproduction studies were performed and resulted in NOEC-values of 45 mg a.s./kg feed and 333 mg a.s./kg feed, the highest concentrations tested.

Key value for chemical safety assessment

Short-term EC50 or LC50 for birds:

5 000 mg/kg food

Long-term EC10, LC10 or NOEC for birds:

45 mg/kg food

Additional information

Five studies on the acute and chronic toxicity of fenpropimorph to aquatic invertebrates are available. All studies were conducted according to GLP and different international guidelines. The test species was the bobwhite quail (Colinus virginianus) and the mallard duck (Anas platyrhynchos).
The studies performed cover a broad range of biological endpoints, such as mortality, signs of toxicity, feed consumption, body weight, post-mortem examinations and various reproduction parameters. The results of the studies are summarised below. The feed concentrations were transformed to daily doses (mg/kg body weight/day) by the notifier based on the study data.

Table 1: Summary of effects of fenpropimorph on birds

Test species	Test system	Results
Colinus virginianus	acute oral toxicity	LD50 > 2000 mg a.s./kg body weight; NOEL = 1000 mg a.s./kg body weight
Anas platyrhynchos	short-term dietary toxicity	LC50 > 5000 mg a.s./kg feed; NOEC = 1250 mg a.s./kg feed
Colinus virginianus	short-term dietary toxicity	LC50 > 5000 mg a.s./kg feed; NOEC = 5000 mg a.s./kg feed
Colinus virginianus	Sub-chronic toxicity and reproduction	NOEC = 45 mg a.s./kg feed; NOEC = 333 mg a.s./kg feed

 

BASF DocumentID	Test substance	Guideline GLP	Test species	Test System	Endpoints	Results
2000/1000184	fenpropimorph	EPA 71-1 Yes	Colinus virginianus	acute oral toxicity, 14d (nom)	Mortality, clinical signs, feed consumption, body weight	LD50 > 2000 mg a.s./kg body weight NOEL = 1000 mg a.s./kg body weight
1988/0635	fenpropimorph	EPA 71-2 Yes	Anas platyrhynchos	short-term dietary toxicity, 8d (nom)	Mortality, signs of toxicity, feed consumption, body weight	LC50 > 5000 mg a.s./kg feed NOEC = 1250 mg a.s./kg feed
1988/0636	fenpropimorph	EPA 71-2 Yes	Colinus virginianus	short-term dietary toxicity, 8d (nom)	Mortality, signs of toxicity, feed consumption, body weight	LC50 > 5000 mg a.s./kg feed NOEC = 5000 mg a.s./kg feed
1983/10086	fenpropimorph	EPA 71-4 Yes	Colinus virginianus	Sub-chronic toxicity and reproduction, 24w (nom)	Mortality, signs of toxicity, feed consumption, body weight, macroscopic post mortem examination, nr of eggs laid, nr of broken/cracked eggs, egg weights/shell thickness, nr of infertile eggs, embryonic deaths, hatching, chick health and mortality, nr of 14-day survivors, body weights of offspring	NOEC = 45 mg a.s./kg feed
2002/1005241	fenpropimorph	EPA 71-4 Yes	Colinus virginianus	Sub-chronic toxicity and reproduction, 21w (nom)	Mortality, body weights of adult birds, reproduction parameter: number of eggs laid, fertility, embryo viability, hatchability, offspring survival, eggshell strength and thickness	NOEC = 333 mg a.s./kg feed