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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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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: Gross or histopathological examination was not performed, big volumes of DMSO was used as a solvent

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Principles of method if other than guideline:
Ten male rats/dose (bw: ca. 160-180 g), single oral application by gavage, substance dissolved in DMSO (2 ml/100 g bw), observation time: 14 d, calculation of LD50 according to Fink (1965) Arzneim.-Forsch. 15, 624
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Phthalic anhydride
EC Number:
201-607-5
EC Name:
Phthalic anhydride
Cas Number:
85-44-9
Molecular formula:
C8H4O3
IUPAC Name:
1,3-dihydro-2-benzofuran-1,3-dione

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
male Wistar-II-rats, SPF, weight 160 - 180 gr, husbandry: 5 animals per cage

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Details on oral exposure:
no further data
Doses:
100, 500, 1000, 2000, 3100, 5000 mg/kg bw in DMSO
No. of animals per sex per dose:
10 males per dose
Control animals:
not specified
Details on study design:
No further data
Statistics:
According Fink and Hund, Arzneimittelforsch. (1965), 15, 624

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
1 530 mg/kg bw
Mortality:
Dose 100 mg/kg, mortality 0/10; dose 500 mg/kg, mortality 2/10; dose 1000 mg/kg, mortality 2/10, dose 2000 mg/kg, mortality 4/10; dose 3100 mg/kg, mortality 9/10; dose 5000 mg/kg, mortality 10/10
Clinical signs:
other: Sedation, disturbances of equilibrium
Gross pathology:
no data
Other findings:
See: Any other information on results including tables

Any other information on results incl. tables

Dose-group, time of death, No of rats which died, No of rats with symptoms:
100 mg/kg bw, no deaths, 0/10, 0/10
500 mg/kg bw, 3-4 d, 2/10, 10/10
1000 mg/kg bw, 3 d, 2/10, 10/10
2000 mg/kg bw, 2-3 d, 4/10, 10/10
3100 mg/kg bw, 2-3 d, 9/10, 10/10
5000 mg/kg bw, 2 d, 10/10, 10/10
Symptoms: sedation, imbalance, and bloody eyes.
No gross or histopathological examination.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Executive summary:

Method: single orale application per gavage of test substance (dose 100, 500, 1000, 2000, 3100, 5000 to 10 male rats, post-observation time 14 days)

Result: LD50 = 1530 mg/kg bw (male rats)

Reference: Loeser (Bayer AG), 1978