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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
Reference substance name:
Salicylic acid
EC Number:
200-712-3
EC Name:
Salicylic acid
Cas Number:
69-72-7
Molecular formula:
C7H6O3
IUPAC Name:
2-hydroxybenzoic acid
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 or test system 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.