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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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:

male/female

Details on test animals or test system and environmental conditions:

The animals were acquired from Texas Animal Specialties; Humble, TX and weighted on the dosing Day: Male: 244-264 gm; Female: 176-185 gm The animals were housed in suspended stainless steel with wire bottom cages 1 per cage. The animal room was maintained at actual Tempt/Relative Humidity of 20-22°C /34-91% with 12-hour light/dark cycle and 10-12 air changes/hour. PMI Feeds Inc.TM Formulab #5008 was available ad libitum and
Municipal water supply (Sugar Land, TX) analyzed by TCEQ Water Utilities Division; tap water, was also available ad libitum (automatic system)

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The animals were prepared on the day prior to treatment by clipping the dorsal surface of the trunk free of hair to expose not less than 10% of the total body surface area. The test substance was applied evenly to each exposure area in a thin, uniform layer. The area of application was covered with a 2 x 4 in. surgical gauze patch and secured with non-irritating adhesive tape. The trunk of each animal was then wrapped with a veterinary flexible cohesive bandage, secured in place with non-irritating adhesive tape to prevent possible ingestion of the test substance,

Duration of exposure:

24 hr

Doses:

approximately 2000 mg/kg of body weight.

No. of animals per sex per dose:

Five

Control animals:

no

Details on study design:

After 24 hour exposure period, the dermal wrappings were removed. The test sites were gently washed with room temperature tap water and a clean cloth to remove as much residual test substance as possible. 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 Observations for evidence of derinal irritation were made at approximately 60 minutes after removal of the dermal wrappings, and on Days 4, 7, 11 and 14. On Day 14 after dosing, animals were 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:

male/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.

Other findings:

There was no evidence of dermal irritation following the 24 hr exposure.

Applicant's summary and conclusion

Interpretation of results:

relatively harmless

Remarks:

Migrated information and not irritating. Criteria used for interpretation of results: OECD GHS

Conclusions:

The test substance has a an acute dermal LD50 of > 2000 mg/kg of body weight in the rat. Furthermore, the test substance was not irritating to the skin under the conditions of the study.

Executive summary:

The test substance, 1,2,3,6 -Tetrahydrophthalic anhydride, oligomeric reaction products with 2,2 -dimethylpropane-1,3 -diol, was evaluated in an O.E.C.D. 402 rat acute dermal toxicity study. The acute dermal LD50 was > 2000 mg/kg of body weight. Furthermore, the test substance was not irritating to the skin under the conditions of the study with a 24 hr exposure period. .