N-[(1,1,3,3-tetramethylbutyl)phenyl]naphthalen-1-amine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

28 Feb 2012 - 06 Mar 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: MatTek Corporation, Ashland, MA 01721, USA: EpiOcularTM human cell construct: Procedure details, Version 3.1a of February 10, 2010

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Harbell J.W. et al. (2009): COLIPA Program on Optimization of Existing In Vitro Eye Irritation Assays for Entry into Formal Validation: Technology Transfer and Intra/Inter Laboratory Evaluation of EpiOcular Assay for Chemicals. Poster # 378, Society of To

GLP compliance:

yes (incl. QA statement)

Remarks:

BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany

Test material

Test material information

Constituent 1

Reference substance name:

N-[(1,1,3,3-tetramethylbutyl)phenyl]naphthalen-1-amine

EC Number:

257-406-8

EC Name:

N-[(1,1,3,3-tetramethylbutyl)phenyl]naphthalen-1-amine

Cas Number:

51772-35-1

Molecular formula:

C24H29N

IUPAC Name:

N-[(1,1,3,3-tetramethylbutyl)phenyl]naphthalen-1-amine

Details on test material:

- Physical state: solid/white
- Analytical purity: 99.0 g/100 g determined by 1H-MR spectroscopy
- Expiration date of the lot/batch: July 15, 2015
- Storage condition of test material: Room temperature; avoid temperatures > 35°C

Test animals / tissue source

Species:

other: Reconstructed human cornea model EpiOcular(TM)

Strain:

other: Tissue model: OCL-200

Details on test animals or tissues and environmental conditions:

N/A

Test system

Vehicle:

other: tissue was pretreated with PBS, test item added unchanged

Controls:

other: Two tissues were each treated with positive and negative controls

Amount / concentration applied:

50 µl of test material

Duration of treatment / exposure:

90 minutes

Number of animals or in vitro replicates:

Two tisssues per sample

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with sterile PBS
- Time after start of exposure: 90 minutes

Results and discussion

In vitro

Results

Irritation parameter:

other: tissue viability in %

Run / experiment:

test material

Value:

98

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Any other information on results incl. tables

RESULTS

		tissue 1	tissue 2	mean	inter-tissue variability [%]
negative control	mean OD570	1.488	1.665	1.577
	viability [% of NC]	94.4	105.6	100	11.2
test material	mean OD570	1.419	1.685	1.522
	viability [% of NC]	90	106.9	98	16.9
positive control	mean OD570	0.296	0.327	0.311
	viability [% of NC]	18.7	20.7	20	2

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the observed results it was concluded, that the test substance does not show an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen.

Executive summary:

The potential of the test article to cause ocular irritation was assessed by a single topical application of 50 μL bulk volume (about 19 mg) of the test substance to a reconstructed three dimensional human cornea model (EpiOcular™). Two EpiOcular™ tissue samples were incubated with the test substance for 90 minutes followed by a 18-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability. The EpiOcular™ eye irritation test showed the following results:

The test substance is not able to reduce MTT directly. The mean viability of the test-substance treated tissues was 98%. Based on the observed results it was concluded, that the test substance does not show an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen.