Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OTS 798.4100 (Skin Sensitisation)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
Non LLNA in vivo study already available in litterature

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male

Study design: in vivo (non-LLNA)

No. of animals per dose:
4

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
12.5 % w/v
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% w/v
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 % w/v
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75 % w/v
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
12.5 % w/v
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 % w/v
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75
No. with + reactions:
0
Total no. in group:
5

Applicant's summary and conclusion

Conclusions:
The test article produced no irritation following the callenge dose. Based on the results, Technical Butralin is not considered a dermal sensitizer.
Executive summary:

The test article was dermally administered to quigena pids once weekly for three weeks for the induction phase. Animals were challenged after a two-week rest period at a site other than the one used for the induction doses. The test article produced no irritation following the callenge dose. Based on the results, Technical Butralin is not considered a dermal sensitizer.