Registration Dossier

Toxicological information

Acute Toxicity: other routes

Currently viewing:

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No OECD guideline or GLP defined

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1942

Materials and methods

Principles of method if other than guideline:
Intraperitoneal injections of phthalic acid were given to 3-months-old, male, white mice. Six mice were kept in one cage; 4 such groups were simultaneously injected with a given dosage using a tuberculin syringe. The mice ranged from 18-22 g in weight; average weight: 20g. The mice were observed periodically and the total number dead at the end of 24 hours was taken as the kill for a given dosage. All of the mice surviving 24 hours recovered. The phthalic acid was given as a saturated solution which was shown to contain 0.01 g of phthalic acid per ml. Higher doses than 12 mg per mouse were not feasible since this dosage requred the intraperitoneal injection of 1.2 ml which is a large volume compared to the size of the peritoneal cavity.
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Test animals

Species:
mouse
Strain:
other: white mice
Sex:
male

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
not specified
Doses:
6, 8, 10, 12 mg/kg
No. of animals per sex per dose:
24-41 mice
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
ca. 0.55 other: g/kg bw

Any other information on results incl. tables

Data on Dosage and Percentage Mortality:

           
  No. mice  Dosage  No. dead  Mortality %   
  24  6 mg   
  24  8 mg  11  44   
  41  10 mg  19  46   
  24  12 mg  12  50   
           

Applicant's summary and conclusion

Executive summary:

In an acute toxicity study intraperitonel injections of Phthalic Acid (PA) were given to 3 -months-old, male mice. The PA was given as a saturated solution which was shown to contain 0.01 g of PA per ml. There was some cyanosis noted; the mice hopped about spasmodically, standing on their hind legs. In certain mice, autopsy showed an apparent subcutaneous hemorrhage in the nasal region; the livers exhibited white spots of unknown etiology.

The dose required to kill the average mouse (LD 50) was calculated to be 0.55 g per kg body weight.