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:
supporting study
Study period:
1946 or before
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study published in a peer-reviewed journal, according to scientific standards. Experimental details documented, but no data on acclimatization and housing. Results: Mortalities tabulated after 1 and 7 days, but no statistical determination of LD50. Performed 1946, before GLP and OECD guidelines were introduced. Sufficient numbers of animals investigated, but sex not stated.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Pharmacological and toxicological studies on salicylamide
Author:
Ichniowski CT & Hueper WC
Year:
1946
Bibliographic source:
J. Am. Pharm. Assoc. Sci. Ed. 35: 225-230

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Acute toxicity study with intraperitoneal application, otherwise similar to acute oral toxicity.
GLP compliance:
no
Remarks:
GLP not available at study time
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Salicylamide
EC Number:
200-609-3
EC Name:
Salicylamide
Cas Number:
65-45-2
Molecular formula:
C7H7NO2
IUPAC Name:
2-hydroxybenzamide
Details on test material:
- Substance type: Pure test substance
- Physical state: Solid; yellowish white crystalline powder
- Melting Point: 138°
- Taste: Practically tasteless

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: 0.5% gum tragacanth in water
Doses:
250, 500, 1000, and 1500 mg/kg body weight
No. of animals per sex per dose:
10 (sex not specified)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: 15, 30, 60, 90 min, 2, 3, 5, 24 h, daily until day 7; no weighing reported
- Necropsy of animals dying on test: yes
- Necropsy of survivors: not reported
- Other examinations performed: clinical signs
Statistics:
none

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 500 - < 1 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No statistical evaluation; mortalities 2/10 at 500 mg/kg bw; 9/10 at 1000 mg/kg bw
Mortality:
Mortalities 1/10 at 250 mg/kg bw; 2/10 at 500 mg/kg bw; 9/10 at 1000 mg/kg bw; 10/10 at 1500 mg/kg bw
All mortalities within 2 h after application, except for one animal in the lowest dose group, which was reported to be in good condition, and whose time and circumstances of death are not stated
Clinical signs:
Heavy depression (dose-dependent), hind leg paralysis
Recovery of survivors within 24 hours
Body weight:
no data
Gross pathology:
Congestion and hemorrhages of the lungs
Hyperemia of the meninges
All other organs grossly normal

Applicant's summary and conclusion