Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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:
There were no signs of toxicity during the 14-day post-dosing observation period.
Body weight:
All rats gained weight during the 14-day post-dosing 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.