Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
Depression soon after treatment
Body weight:
no data
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).