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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

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 437 resp. EU Method B.47 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

GLP compliance:

yes (incl. QA statement)

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 (CAS number: 135452-43-6).

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 (CAS number: 135452-43-6).

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

Test system

Vehicle:

other: olive oil

Duration of treatment / exposure:

incubation time: 4 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: IVIS (in vitro irritancy score)

Basis:

other: Test group 1

Time point:

other: 4 hours (incubation time)

Score:

0.933

Results 2

Irritation parameter:

other: IVIS (in vitro irritancy score)

Basis:

other: Test group 2

Time point:

other: 4 hours (incubation time)

Score:

1.06

Results 3

Irritation parameter:

other: IVIS (in vitro irritancy score)

Basis:

other: Test group 3

Time point:

other: 4 hours (incubation time)

Score:

0.264

Results 4

Irritation parameter:

other: IVIS (in vitro irritancy score)

Basis:

other: Mean IVIS

Time point:

other: 4 hours (incubation time)

Score:

0.752

Any other information on results incl. tables

The test item showed no effects on the cornea of the bovine eye. The calculated mean IVIS (in vitro irritancy score) is 0.752.

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item possesses no eye irritation potential (according to ICCVAM).

According to OECD 437 (2009), a substance that induces an IVIS >=55.1 is defined as a corrosive or severe irritant.

Therefore, the test item is classified as “non-corrosive” and/or “no severe irritant”.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item showed no effects on the cornea of the bovine eye. It can be stated that in this study and under the experimental conditions reported, the test item possesses no eye irritation potential (according to ICCVAM). It is classified as “non corrosive” and/or “no severe irritant”