Registration Dossier

Administrative data

Endpoint:
specific investigations: other studies
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: (meets generally accepted scientific standards, well-documented, and acceptable for assessment)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Endpoint: mortality
LD50
GLP compliance:
no
Type of method:
in vivo

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Colinnus virginianus (avian)
Sex:
not specified
Details on test animals and environmental conditions:
Young adult (14-18 week-old) quail were reared in a private colony at the testing facility. Birds were observed for 24 days prior to placement on test, and were examined by a laboratory veterinarian

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Eposure period: 1 minute
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 316, 681, 1000, 1470, and 2150 mg/kg
Basis:

No. of animals per sex per dose:
Birds were randomly divided into 1 vehicle control group (tap water) and 5 treatment groups (5 males and 5 females per group) based on body weights.
Control animals:
yes, concurrent vehicle
Details on study design:
Birds were fasted for 16 hours prior to dosing by gavage, and were permitted a commercial food and water ad libitum at all other times. Birds were housed 10 per pen in an indoor environment with controlled lighting, temperature, and relative humidity. Food consumption was recorded on days 3, 7, 14, and 21. Observations were made daily for clinical signs of toxicity indicative of test material effect. All birds dying during the study and four arbitrarily-selected birds were sacrificed on day 21 and subjected to a complete gross pathological examination.

Examinations

Examinations:
Body weights
Food consumption

Results and discussion

Details on results:
Birds were anorexic and lethargic at doses >681 mg/kg/day. One control bird was cannabalized.

Treated birds found dead had discolored kidneys and liver; survivors were largely normal. Treated birds lost weight and consumed less feed.

The estimated oral LD50 for the test material in quail was 1100 (830-1450) mg/kg bw.

Applicant's summary and conclusion

Conclusions:
The estimated oral LD50 for the test material in quail was 1100 (830-1450) mg/kg.