Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
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:
2011
Report Date:
2011

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
As per IUCLID Sections 1.1. 1.2. 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 Day-i Wt/Day 0 (fasted) Wt: 180-205 gm / 162-187 gm. The animals were housed one/cage in suspended stainless steel with wire bottom. The Actual Temp/Relative Humidity during the study was 19-22°C /30-91% respectively. There was a 12-hour light/dark cycle and 10-12 air changes/hour in the animal rooms. PMI Feeds Inc.Formulab #5008; was available ad libitum except for approximately 16 hours before dosing. Municipal water supply analyzed by TCEQ Water Utilities Division; was also
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 1.67 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:
2000 mg/kg of body weight Limit Dose.
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
Following dosing observations for mortality and clinicall 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:
None required.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
Animals exhibited normal weekly weight gain during the study.
Gross pathology:
There were 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 rat acute oral LD50 for the test substance was determined to be > 2000 mg/kg of body weight.
Executive summary:

The test substance, 1,2,3,6 -Tetrahydrophthalic anhydride, oligomeric reaction products with 2,2 -dimethylpropane-1,3 -diol was evaluated for acute oral toxicity in an O.E.C.D. test guideline 425 study. No mortalities occured during the study. Therefore the rat acute oral LD50 is > 2000 mg/kg of body weight.