Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24.2 - 10.3.2004
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
sodium 2-(4-methoxybiphenyl-3-yl)hydrazinesulfonate
Molecular formula:
C13H13N2O4SNa
IUPAC Name:
sodium 2-(4-methoxybiphenyl-3-yl)hydrazinesulfonate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality (male/female)
Clinical signs:
(male/female)
30 minutes after application: only bristly hair
3 hours after application: no clinical signs
14 days after application: no clinical signs
Body weight:
(mean of 3 males)
before application: 182.33 g
8th day after application: 249.53 g
15th day after application: 295.87 g

(mean of 3 females)
before application: 157.97 g
8th day after application: 176.14 g
15th day after application: 188.09 g
Gross pathology:
males/females: pulmonary edema

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Non toxic according to CLP and DSD criteria.