2-Hydroxy-1-{3-[4-(2-hydroxy-2-methylpropanoyl)phenyl]-1,1,3-trimethyl-2,3-dihydro-1H-inden-5-yl}-2-methylpropan-1-one

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test was conducted according to OECD 429 and compliant with GLP. Read-across from supporting substance (structure analogue or surrogate). Test substance (source substance): CAS No. 135452-43-6

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

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:

2-hydroxy-1-{1-[4-(2-hydroxy-2-methylpropanoyl)phenyl]-1,3,3-trimethyl-2,3-dihydro-1H-inden-5-yl}-2-methylpropan-1-one

IUPAC Name:

2-hydroxy-1-{1-[4-(2-hydroxy-2-methylpropanoyl)phenyl]-1,3,3-trimethyl-2,3-dihydro-1H-inden-5-yl}-2-methylpropan-1-one

Constituent 2

Reference substance name:

135452-43-6

Cas Number:

135452-43-6

IUPAC Name:

135452-43-6

Constituent 3

Reference substance name:

1-Propanone, 1-[2,3-dihydro-1-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1,3,3-trimethyl-1H-inden-5-yl]-2-hydroxy-2-methyl-

IUPAC Name:

1-Propanone, 1-[2,3-dihydro-1-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1,3,3-trimethyl-1H-inden-5-yl]-2-hydroxy-2-methyl-

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Chivacure 300P

In vivo test system

Test animals

Species:

mouse

Strain:

other: CBA/CaOlaHsd

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

The test item in the main study was assayed at 10, 25 and 50% (w/w).

No. of animals per dose:

Number of animals for the pre-test: 2 females
Number of animals for the main study: 16 females
No. of animals per dose (main study): 4 females

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: In this study Stimulation Indices (S.I.) of 0.84, 0.75 and 1.22 were determined with the test item at concentrations of 10, 25 and 50%(w/w) in DMF, respectively.

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: The proliferative response of the lymph node cells is expressed as the number of radioactive disintegrations per minute per lymph node (DPM/lymph node)

Any other information on results incl. tables

Test item concentration % (w/w)	Group	Measuremenr DPM	Stimulation Index
0	1	1333	1.00
10	2	1119	0.84
25	3	1006	0.75
50	4	1616	1.22

The EC3 value could not be calculated, since all S.I .’s are below the threshold value of 3.

In this study Stimulation Indices of 0.84, 0.75 and 1.22 were determined with the test item at concentrations of 10, 25 and 50% (w/w) in DMF. The EC3 value could not be calculated, since non of the tested concentrations induced a S.I. greater than the threshold value of 3.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is not a skin sensitiser under the test conditions of the this study.