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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Data is from experimental study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Acute oral toxicity study for test chemical in rat.
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 3-nitrobenzenesulphonate
EC Number:
204-857-3
EC Name:
Sodium 3-nitrobenzenesulphonate
Cas Number:
127-68-4
Molecular formula:
C6H5NO5S.Na
IUPAC Name:
sodium 3-nitrobenzenesulfonate
Test material form:
solid
Details on test material:
- Name of test material : Sodium 3-nitrobenzenesulphonate
- Molecular formula : C6H4NNaO5S
- Molecular weight : 225.1556 g/mol
- Smiles notation : c1(cc(ccc1)[N+](=O)[O-])S(=O)(=O)[O-].[Na+]
- InChl : 1S/C6H5NO5S.Na/c8-7(9)5-2-1-3-6(4-5)13(10,11)12;/h1-4H,(H,10,11,12);/q;+1/p-1
- Substance type : Organic
- Physical state : Solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: Mean body weight was 180 and 220 g for male dose groups 5000 and 2150, respectively, and 170 g for the two female dose groups.
- Fasting period before study: 15 - 20 h before application

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
MAXIMUM DOSE VOLUME APPLIED: The substance was applied as a single oral dose as a 10 mL suspension.
Doses:
2150, 5000 mg/kg b.w.
No. of animals per sex per dose:
5 (sex/dose)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes, the post-exposure period was 14 days after which the animals were sacrificed and subjected to a gross-pathological examination.
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed at 5000 mg/kg bw.
Clinical signs:
Staggering was the only clinical symptom noted at the dose level of 5000 mg/kg b.w.
Body weight:
Males, 5000 mg/kg: beginning of the study 180 g, after 13 d 274 g; 2150 mg/kg: beginning of the study 220 g, after 13 d 250 g
Females, 5000 mg/kg: beginning of the study 170 g, after 13 d 205 g; 2150 mg/kg: beginning of the study 170 g, after 13 d 212 g
Gross pathology:
Gross pathology did not reveal any abnormal findings. Both sexes showed comparable results.
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The above experimental results prove that the LD50 value for male and female rats was determined to be >5000 mg/kg b.w. Thus, test chemical is not expected to exhibit acute oral toxicity upto the dose levels mentioned in the present study
Executive summary:

Acute oral toxicity study was conducted according to OECD Guideline 401 (Acute Oral Toxicity) by using test chemical in 20 male and female Sprague-Dawley rats at the dose concentration of 2150 and 5000 mg/kg bw.

The substance was applied as a single oral dose as a 10 mL suspension in CMC (carboxymethyl cellulose). The post-exposure period was 14 days after which the animals were sacrificed and subjected to a gross-pathological examination.

No mortality was observed at 5000 mg/kg bw. Staggering was the only clinical symptom noted at the dose level of 5000 mg/kg b.w. Body weight changes was observed. Gross pathology did not reveal any abnormal findings. Both sexes showed comparable results.

Therefore, LD50 was considered to be >5000 mg/kg bw, when 20 male and female Sprague-Dawley rats were treated with test chemical via oral gavage route.