1H-Indol-2-ol, 1-[(difluoromethyl)sulfonyl]-3-(4,6-dimethoxy-1,3,5-triazin-2-yl)-7-fluoro-

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to EU/OECD-guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

1-difluoromethanesulfonyl-3-(4,6-dimethoxy-1,3,5-triazin-2-yl)-7-fluoro-1H-indol-2-ol

EC Number:

930-430-2

Cas Number:

1383692-20-3

Molecular formula:

C14H11F3N4O5S

IUPAC Name:

1-difluoromethanesulfonyl-3-(4,6-dimethoxy-1,3,5-triazin-2-yl)-7-fluoro-1H-indol-2-ol

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

50, 25 and 10 % (w/v) in AOO

No. of animals per dose:

twenty-five female CBA/J Rj mice were allocated to five groups of five animals each

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: The stimulation index values were 1.87, 2.98 and 3.11 at concentrations of 50, 25 and 10 % (w/v), respectively.

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: see table

Any other information on results incl. tables

Test Group Name	Animal No	DPM	Stimulation Index
Negative control (AOO)	1	386.5	1.00
	2	276.5
	3	321.5
	4	529.5
	5	325.5
50 % (w/v) in AOO	6	347.5	1.87
	7	950.5
	8	1335.5
	9	521.5
	10	280.5
25 % (w/v) in AOO	11	1626.5	2.98
	12	382.5
	13	1482.5
	14	1292.5
	15	706.5
10 % (w/v) in AOO	16	1933.5	3.11
	17	1319.5
	18	1143.5
	19	674.5
	20	650.5
Positive control (25 % HCA) in AOO	21	1833.5	15.74
	22	3812.5
	23	9031.5
	24	11063.5
	25	3205.5

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In conclusion, under the conditions of the present assay the test item was shown to have a weak sensitization potential (sensitizer) in the Local Lymph Node Assay.