Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the O.E.C.D. test guideline 425 with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
other: Colorless liquid at room temperature.
Details on test material:
As per IUCLID5 Sections 1.1. 1.2. 1.4. and 4.1.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
Female rats were acquired from Texas Animal Specialties; Humble, TX. and were Quarantined for 5 days before being placed on study. The animals weighted 172-222 gm on Day 0 (fasted). The animals were maintained in suspended stainless steel cages with wire bottom, I per cage. The temperature was 18-21°C and relative humidity was 29-95%. The animal room had 10-12 air changes/hour and a 12-hour light/dark cycle. PMI Feeds Inc.TM Formulab #5008 was available ad libitum except for approximately 16 hours before dosing. Municipal water supply analyzed by TCEQ Water Utilities Division was available ad libitum from automatic water system.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test substance was administered as received and was not diluted. An individual dose was calculated for each animal based on its fasted body weight and administered by gavage at a volume of 1.88 mL/kg. Each dose was administered using an appropriately sized syringe and stainless steel ball-tipped intubation needle. The animals were returned to their cages immediately after dosing.

Doses:
Approximately 2000 mg/Kg of body weight.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Observations for mortality and clinical/behavioral signs of toxicity were made at least three times on the day of dosing (Day 0) and at least once daily thereafter for 14 days. Individual body weights were recorded just prior to dosing and on Days 7 and 14, or at the time of discovery after death.

On Day 14 after dosing, each surviving animal was euthanized by an overdose of CO2. All study animals, whether dying during the study or euthanized, were subjected to gross necropsy and all abnormalities were recorded.
Statistics:
None required.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
one animal
Clinical signs:
Clinical signs in one survivor included activity decrease, crusted muzzle, nasal discharge and piloerection, which were no longer evident by Day 3.
Body weight:
Animals surviving to study termination exhibited weekly normal weight gain during the study.
Gross pathology:
The gross necropsy on the animal that died on test revealed discolored lungs, liver and contents in the large intestine; and empty stomach and small intestine. The gross necropsy on animals surviving to study termination of the study revealed no observable abnormalities.

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The rate acute oral LD50 of the test substance is > 2000 mg/kg of body weight.
Executive summary:

The acute oral toxicity of the test substance, Neononanoic acid glycidyl ester was accessed by an O.E.C.D. test guideline 425 UDP method. The rate acute oral LD50 of the test substance is > 2000 mg/kg of body weight under the conditions of the study.