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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OTS 798.1100 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(tert-butyl)-N-sec-butyl-2,6-dinitroaniline
EC Number:
251-607-4
EC Name:
4-(tert-butyl)-N-sec-butyl-2,6-dinitroaniline
Cas Number:
33629-47-9
Molecular formula:
C14H21N3O4
IUPAC Name:
N-sec-butyl-4-tert-butyl-2,6-dinitroaniline
impurity 1
Chemical structure
Reference substance name:
Xylene
EC Number:
215-535-7
EC Name:
Xylene
Cas Number:
1330-20-7
Molecular formula:
C8H10
IUPAC Name:
m-xylene

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Vehicle:
corn oil
Duration of exposure:
2 weeks
Doses:
2 g/kg
No. of animals per sex per dose:
5

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Technical Butralin is not considered toxic when administered dermally at 2 g/kg.
Executive summary:

A single 2 g/kg dermal dose of CFPI test article technical Butralin was administratered to a group of five male and five female rats. All animals survived the fourteen-day observation period, and no severe or irreversible signs of treatment-related toxicity were observed. Based on the results of this study CFPI test article Technical Butralin is not considered toxic when administered dermally at 2 g/kg.