Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Remarks:
Sample sent to sa-FORD, Plot V -10, MIDC Industrial Area, Taloja, Dist Raigad, Navi Mumbai, PIN: 410208, Maharashtra, India
Type of information:
experimental study
Adequacy of study:
key study
Study period:
74 days
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: bulk

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 50 - < 300 mg/kg bw
Based on:
test mat.
Remarks on result:
other:

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
Acute Oral Toxicity study for Thioctamidoethyl Dimethylamie Maleate was performed on wistar Rat (female) and is classified as 'Category 3' in Compliance with the OECD guidelines No. 423.