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

Endpoint summary

Description of key information

1,2,3,6-tetrahydrophthalic anhydride, oligomeric reaction products with 2,2-dimethylpropan-1,3-diol used as read-across chemical was tested for acute toxicity in an OECD 425 acute oral toxicity in rats and in a OECD 422 acute dermal toxicity in rats. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Please refer to the Read-Across justification document englosed in chapter 13 for more details.

Reason / purpose for cross-reference:

read-across source

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

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.

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Please refer to the Read-Across justification document englosed in chapter 13 for more details.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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)

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.

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.

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. .

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

The acute dermal and oral LD50 values for 1,2,3,6-tetrahydrophthalic anhydride, oligomeric reaction products with 2,2-dimethylpropan-1,3-diol used as read-across chemical was greater than 2000 mg/kg body weight. Furthermore, no evidence of dermal irritation was noted during the acute dermal toxicity study.

Justification for classification or non-classification

- oral toxicity:

Based on the above stated assessment of the acute oral toxicity (absence of toxicity up to 2000 mg/kg) the substance does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and accordingCLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council)as implementation of UN-GHS in the EU.

- dermal toxicity:

Based on the above stated assessment of the acute dermal toxicity (absence of toxicity up to 2000 mg/kg) the substance does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and accordingCLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council)as implementation of UN-GHS in the EU.