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:
August 1989-September 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from experimental report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Acute Oral toxicity test was carried out to study the effects of test chemical on rats.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (IUPAC name): Sodium salicylate
- Common name: Monosodium salicylate
- Molecular formula: C7H6O3.Na
- Molecular weight: 160.1035 g/mol
- Smiles notation: c1(c(cccc1)O)C(=O)[O-].[Na+]
- InChl: 1S/C7H6O3.Na/c8-6-4-2-1-3-5(6)7(9)10;/h1-4,8H,(H,9,10);/q;+1/p-1
- Substance type: Organic

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
no data available

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Details on oral exposure:
no data available
Doses:
200,2000 mg/kg bw
No. of animals per sex per dose:
3 male/female (200 mg/kg)
3 male(2000 mg/kg)
Control animals:
not specified
Details on study design:
no data available
Statistics:
no data available

Results and discussion

Preliminary study:
no data available
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
other: MLD
Effect level:
200 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
other: MLD
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: mortality was observed
Mortality:
all male rats died at dose 2000 mg/kg bw
Clinical signs:
no data available
Body weight:
no data available
Gross pathology:
no data available
Other findings:
no data available

Any other information on results incl. tables

 

 

Number of treated animals

Number of animals died

 

 

Female

Male

Female

Male

1

Test dose: 2000 mg

Test step 1

Test step 2

 

-

-

 

3

-

 

-

-

 

3

-

2

Test dose: 200 mg

Test step 1

Test step 2

 

-

3

 

3

-

 

-

0

 

0

-

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Conclusions:
The mean lethal dose (MLD) of test chemical in male and female wistar rat was considered to be > 200<= 2000 mg/kg of body weight. Acute oral toxicity of test chemical to rat by oral route indicates that test chemical exhibits acute toxicity by the oral route in the Category 4.
Executive summary:

The mean lethal dose (MLD) of test chemical in male and female wistar rat was considered to be > 200<= 2000 mg/kg of body weight. Acute oral toxicity of test chemical to rat by oral route indicates that test chemical exhibits acute toxicity by the oral route in the Category 4.