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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:
other: Valid scientific study, precedes guideline and GLP. Documentation is limited.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report date:
1963

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Principles of method if other than guideline:
Test method is not described for this study, but a method is available for a concurrent study on a structural analogue (BTA) of this substance (BTDA) commissioned in the same laboratory. Therefore, it is likely that the method for the BTDA is identical to that of BTA, and therefore this method is described in the following record. Both studies precede the establishment of OECD methods and GLP.
GLP compliance:
no
Remarks:
precedes establishment of GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzophenone-3,3':4,4'-tetracarboxylic dianhydride
EC Number:
219-348-1
EC Name:
Benzophenone-3,3':4,4'-tetracarboxylic dianhydride
Cas Number:
2421-28-5
Molecular formula:
C17H6O7
IUPAC Name:
5-(1,3-dioxo-1,3-dihydro-2-benzofuran-5-carbonyl)-1,3-dihydro-2-benzofuran-1,3-dione
Constituent 2
Reference substance name:
291-348-1
IUPAC Name:
291-348-1
Test material form:
not specified

Test animals

Species:
rat
Strain:
other: albino Mason Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Food was withheld from all animals for 3 to 4 hours prior to dosing. Food and water were available ad libitum throughout the observation period. The animals were housed separately suspended above the droppings for the 13 day period of observation.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1% methyl cellulose
Details on oral exposure:
The test material was administered as a single dose by oral gavage. The substance was administered as a suspension in 1% methylcellulose (Methocel). The volumes administered to each respective group of rats varied in relation to the individual animal body weight and each respective dose level.
Doses:
6 doses, ranging from 5000 to 14700 mg/kg body weight.
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
The animals were observed for mortality and pharmacodynamic and/or toxic effects at the following intervals after compound administration: immediately; at 1, 4 and 24 hours; and once daily for 13 days thereafter. At the termination of the observation period, all surviving animals were weighed, sacrificed by decapitation and necropsied.
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
12 800 mg/kg bw
Based on:
test mat.
95% CL:
> 11 400 - < 14 500
Other findings:
At doses of 10,000 mg/kg or higher, BTDA produced gastrointestinal irritation and hemorrhage.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The acute oral LD50 for 1,3-Isobenzofurandione, 5,5'-carbonylbis- (BTDA) is 12,800 mg/kg bw in male rats.