Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Study period:
data not available
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study which meets the basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Acute LD50 by intraperitoneal route
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): acide salicylique
- Substance type: pure active substance
- Stability under test conditions: data not available
- Storage condition of test material: data not available

Test animals

Species:
mouse
Strain:
other: Charles River
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: # 20 g
- Source, Age at study initiation, Fasting period before study, Housing, Diet (e.g. ad libitum), Water, Acclimation period: data not available


ENVIRONMENTAL CONDITIONS
- Temperature, Humidity, Air changes, Photoperiod: data not available


IN-LIFE DATES: data not available

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
not specified
Doses:
420, 500, 600, 720, 865 mg/kg
No. of animals per sex per dose:
6 male mice per group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 10 days
- Frequency of observations and weighing: data not available
- Necropsy of survivors performed: data not available
Statistics:
data not available

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
575 mg/kg bw
Remarks on result:
other: substance left 3 months at 35°C and 90% relative humidity
Sex:
male
Dose descriptor:
LD50
Effect level:
620 mg/kg bw
Remarks on result:
other: fresh substance
Mortality:
Mortality was observed at 600, 720 and 865 mg/kg (see table)
Clinical signs:
data not available
Body weight:
data not available
Gross pathology:
data not available
Other findings:
The difference of LD50 between the two batch is not significant (Chi Square test)

Any other information on results incl. tables

Table 1: Mortality after 10 days

Dose level

(mg/kg)

Mortality after 10 days

Salicylic acid left 3 months at 35°C et at 90% relative humidity

Fresh salicylic acid

420

0 / 6

0 / 6

500

0 / 6

0 / 6

600

4 / 6

3 / 6

720

6 / 6

5 / 6

865

6 / 6

6 / 6

Applicant's summary and conclusion

Executive summary:

In an acute toxicity test, males Charles River mice (6 per dose) were intraperitoneally injected with salicylic acid at the dose levels of 420, 500, 600, 720 and 865 mg/kg bw. The mortality was reported after 10 days.

LD50 batch CA 80 253 73 03 (3 months at 35°C and 90% relative humidity): 575 mg/kg bw

LD50 batch CA 80 253 02 (fresh substance): 620 mg/kg bw

The difference between the two batches was not significant.