4,4'-[(isopropylidene)bis(p-phenyleneoxy)]diphthalic dianhydride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: US EPA Toxic Substance Control Act (TSCA) Health Effects Test Guidelines (1982 and 1984)

Deviations:

no

GLP compliance:

no

Remarks:

Existing study considered to be sufficient for the purpose of REACH registration

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-[(isopropylidene)bis(p-phenyleneoxy)]diphthalic dianhydride

EC Number:

253-781-7

EC Name:

4,4'-[(isopropylidene)bis(p-phenyleneoxy)]diphthalic dianhydride

Cas Number:

38103-06-9

Molecular formula:

C31H20O8

IUPAC Name:

5,5'-[propane-2,2-diylbis(4,1-phenyleneoxy)]bis(2-benzofuran-1,3-dione)

Details on test material:

Biphenol Dianhydride (Bisphenol A Dianhydride; BPA-DA; CAS RN 38103-06-9)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

5000 mg/kg

No. of animals per sex per dose:

5/sex

Details on study design:

An appropriate amount of the test substance was mixed with distilled water to give a 50% concentration. The resulting suspension was administered to five male and five female rats at a dose volume of 10 mL/kg which provided a dose of 5000 mg/kg of bisphenol dianhydride. The dose was administered by gavage through a commercial 16 gauge (3 inch) ball-end stainless steel needle attached to a disposable syringe. The rats were fasted from food overnight (approximately 18 hours) before dosing. The rats weighed between 200 and 250 g and were approximately 5 to 8 weeks of age at the time of dosing. Animals were observed for signs of toxic effects frequently on the day of dosing and twice daily thereafter for 14 days. Body weights were recorded on the day of dosing and at 7 and 14 days after dosing. A gross necropsy was performed on all animals 14 days after dosing.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

All animals survided to scheudled termination.

Clinical signs:

other: There were no signs of toxicity during the 14-day post-dosing observation period.

Gross pathology:

There were no remarkable gross pathologic lesions found at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to EU criteria

Conclusions:

Under the conditions of this study, the oral rat LD50 of the test material was determined to be >5000 mg/kg.

Executive summary:

The acute oral toxicity potential of the test material was determined in accordance with the US EPA Toxic Substance Control Act (TSCA) Health Effects Test Guidelines (Bushy Run Research Center, 1988).

Male and female Sprague-Dawley rats (5/sex) were dosed with the test material in water via gavage at a limit dose of 5000 mg/kg bw.

Under the conditions of this study, the oral rat LD50 was determined to be > 5000 mg/kg bw.