2,2-dimethylpropane-1,3-diyl cyclohex-4-ene-1,2-dicarboxylate

Acute Toxicity: oral

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

GLP compliance:

yes

Test type:

up-and-down procedure

Test material

Test material information

Constituent 1

Reference substance name:

1,2,3,6-Tetrahydrophthalic anhydride, oligomeric reaction products with 2,2-dimethylpropane-1,3-diol

EC Number:

500-091-1

EC Name:

1,2,3,6-Tetrahydrophthalic anhydride, oligomeric reaction products with 2,2-dimethylpropane-1,3-diol

Cas Number:

36621-20-2

Molecular formula:

(C8H8O3.C5H12O2)x

IUPAC Name:

1,2,3,6-Tetrahydrophthalic anhydride, oligomeric reaction products with 2,2-dimethylpropane-1,3-diol

Constituent 2

Reference substance name:

1,3-Isobenzofurandione, 3a,4,7,7a-tetrahydro-, polymer with 2,2-dimethyl-1,3-propanediol

IUPAC Name:

1,3-Isobenzofurandione, 3a,4,7,7a-tetrahydro-, polymer with 2,2-dimethyl-1,3-propanediol

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 or test system 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:

other: None

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.