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
Test material form:
other: Liquid at room temperature.
Details on test material:
As per IUCLID5 Sections 1.1. 1.2. and 4.1.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
The animals were acquired from Texas Animal Specialties; Humble, TX and weighted 176-197 gm when placed on study. They were housed in suspended stainless steel with wire bottom caged at 1 per cage. The conditions in the animal room were, 20-21°C and 41-92% relative humidity with a 12-hour light/dark cycle and 10-12 air changes/hour.

PMI Feeds lnc.TM Formulab #5008 was available to the animals 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 approximately 1.82 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:
Limit Dose of 2000 mg/kg of body weight.
No. of animals per sex per dose:
5 females
Control animals:
no
Details on study design:
Following dosing, 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.

On Day 14 after dosing, each animal was euthanized by an overdose of CO2. All study animals were subjected to gross necropsy and all abnormalities were recorded.

Statistics:
No required.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
approximate LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
Normal body weight gain was observed
Gross pathology:
The gross necropsy conducted at termination of the study revealed no observable abnormalities.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test substance was found to have an acute oral LD50 of > 2000 mg/kg of body weight. No evidence of adverse effects were observed at the Limit Dose level of 2000 mg/Kg of body weight.
Executive summary:

The test substance, Formaldehyde, polymer with 1,3 -benzenedimethanamine and phenol was accessed for acute oral toxicity to the rat in an O.E.C.D. test guideline 425 study. The test substance was found to have an acute oral LD50 of > 2000 mg/kg of body weight. No evidence of adverse effects were observed at the Limit Dose level of 2000 mg/Kg of body weight.