Calcium dilactate

Toxicity to birds

Administrative data

Endpoint:

short-term toxicity to birds: acute oral toxicity test

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

L-(+)-lactic acid

EC Number:

201-196-2

EC Name:

L-(+)-lactic acid

Cas Number:

79-33-4

IUPAC Name:

2-hydroxypropanoic acid

Details on test material:

SY-83

Dose method:

gavage

Analytical monitoring:

not specified

Vehicle:

yes

Details on preparation and analysis of diet:

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

Test organisms

Test organisms (species):

Colinus virginianus

Details on test organisms:

Apparently healthy, pen-reared, mature bobwhite, phenotypically indistinguishable from wild birds, were brought into the laboratory facility, examined for physical injury and acclimated for at least 14 days.

Study design

Limit test:

no

Remarks:

Single dose test

Post exposure observation period:

14 days

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

10 (5 m, 5 f)

Nominal and measured doses / concentrations:

292, 486, 810, 1350 and 2250 milligrams of SY-83 per kilogram of body weight.

Details on test conditions:

ACCLIMATION
- Acclimation period: 14 d
- Acclimation conditions (same as test or not): same
- Feeding: ad lib
- Health (any disease or mortality observed): none
- Fasting period before study: 15 h


PEN SIZE AND CONSTRUCTION MATERIALS
The birds were housed indoors during the test period by treatment group in modified Georqia Quail Farm Breeder units (Model No. 0010). Each pen measured approximately 78 X 51 X 23 cm. high and housed five cocks or five hens. External walls,ceilings an dfloors were constructed of galvanized wire grid, while the common walls were constructed of galvanized sheeting.

NO. OF BIRDS PER REPLICATE
- For negative control: 10
- For treated: 10


NO. OF REPLICATES PER GROUP
- For negative control: 1
- For treated: 1


TEST CONDITIONS (range, mean, SD as applicable)
Average temperature for the study was 77°F ± 4°F (SD), with an average relativ ehumidity of 74%. Th ephotoperiod (maintained by a time clock) was eight hours of light per day throughou tth estudy. The birds received approximately twelve footcandles of illumination. The light source was Chroma 50 fluorescent lights which closely approximate noon-day sunlight (noon-day sun - 4870° Keivin, Chroma 50 - 5000° Keivin).

Examinations

Details on examinations and observations:

All birds were observed daily throughout the study, and a record was maintained of all mortalities and/or signs of toxicity and abnormal behavior. The LD50 value of SY-83 to the bobwhite was determined by inspection.
Body weights were recorded individually at initiation, and by group on Days 3, 7, an da tterminatio no fthe study on Day 14. Feed consumption was measured for Days 0-3, 4-7, and 8-14. Feed consumption was measured accurately but is presented as an estimate due to the unavoidable wastage by the birds.

Reference substance (positive control):

no

Results and discussion

Effect levels

Duration (if not single dose):

14 d

Dose descriptor:

LC50

Effect level:

> 2 250 mg/kg bw

Conc. / dose based on:

test mat.

Basis for effect:

mortality

Mortality and sub-lethal effects:

There was an apparent dosage related effect on body weight of males at the 1350 mg/kg and 2250 mg/kg dosages for Days 0-3. There appeared to be no effect on feed consumption at any dosage.

Further details on results:

In conclusion, the acute oral LD50 value of SY-83 to the bobwhite for this study was determined to be greater than 2250 mg/kg, the highest dosage tested. There were no mortalities at any dosage tested. Based upon effects on male body weight at 1350 and 2250 mg/kg, the no- observed-effect dosage was 810 mg/kg.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In conclusion, the acute oral LD50 value of SY-83 to the bobwhite for this study was determined to be greater than 2250 mg/kg, the highest dosage tested. There were no mortalities at any dosage tested. Based upon effects on male body weight at 1350 and 2250 mg/kg, the no- observed-effect dosage was 810 mg/kg.

Executive summary:

The acute oral LD50 value of SY-83 to the bobwhite for this study was determined to be greater than 2250 mg/kg, the highest dosage tested. There were no mortalities at any dosage tested. Based upon effects on male body weight at 1350 and 2250 mg/kg, the no- observed-effect dosage was 810 mg/kg. Since lactic acid is an essential molecule for life and has an extensive role in metabolism, this may be just a result of an equilibrium shift in metabolic pathways.