Methyl salicylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The method is similar to the OECD guideline 401 and the test was ordered by the US FDA. However, compliance with GLP was not stated and the dose levels are unknown. No information on test substance purity

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Food flavorings and compounds of related structure. I. Acute oral toxicity

Author:

Jenner PM, Hagan EC, Taylor JM et al

Year:

1964

Bibliographic source:

Food Cosmet Toxicol 2:327-343

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methyl salicylate

EC Number:

204-317-7

EC Name:

Methyl salicylate

Cas Number:

119-36-8

Molecular formula:

C8H8O3

IUPAC Name:

methyl salicylate

Details on test material:

- Name of test material (as cited in study report): Methyl salicylate

Test animals

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: 18 hours
- Housing: no data
- Diet (e.g. ad libitum): ad libitum after dosing
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

no data

No. of animals per sex per dose:

5

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, mortality

Statistics:

LD50 computed by the method of litchfield & Wilcoxon, 1949

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

887 mg/kg bw

95% CL:

715 - 1 100

Remarks on result:

other: slope 1.5 (1.2-1.8)

Mortality:

Deaths from 4 to 18 hours

Clinical signs:

other: Depression soon after treatment

Gross pathology:

no data

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is considered as harmful according to EU criteria and is classified in Category 4 according to the GHS (UN/EU)

Executive summary:

The acute oral toxicity of methyl salicylate (purity unknown) was tested in a test similar to OECD guideline 401. five rats per sex per group were administrated a single dose of the undiluted test substance. No details of dose levels were reported. The animals were then observed for 14 days.

Under the conditions of this test, the LD50 was 887 (715 -1100) mg/kg bw. Signs of toxicity were depression soon after treatment. Based on the results of this study, methyl salicylate would be classified as harmful in male and female rats by oral route, according to EU DSD criteria and is classified in Category 4 according to the GHS (UN/EU).