2,2,3-trimethylcyclopent-3-enylacetonitrile

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015-05-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD Guideline and GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

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)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Bovine Corneal Opacity and Permeability (BCOP) Assay, SOP of Microbiological Associates Ltd., UK, Procedure Details, April 1997

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2,2,3-trimethylcyclopent-3-enylacetonitrile

EC Number:

239-405-4

EC Name:

2,2,3-trimethylcyclopent-3-enylacetonitrile

Cas Number:

15373-31-6

Molecular formula:

C10H15N

IUPAC Name:

2-(2,2,3-trimethylcyclopent-3-en-1-yl)acetonitrile

Test animals / tissue source

Species:

other: bovine

Details on test animals or tissues and environmental conditions:

- Freshly isolated bovine cornea (at least 9 month old donor cattle)
- Source: Schlachthof Bensheim, 64625 Bensheim, Germany

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.75 mL
- Concentration: undiluted

Duration of treatment / exposure:

10 min

Observation period (in vivo):

not applicable

Number of animals or in vitro replicates:

3 cornea per substance

Results and discussion

In vivo

Results

Irritation parameter:

other: IVIS

Basis:

mean

Time point:

other: 10 min

Score:

0.23

Reversibility:

other: not applicable

Remarks on result:

other: BCOP test result

Any other information on results incl. tables

Results after 10 min incubation time

Test group	Opacity value = Difference (t130-t0) of Opacity		Permeability at 490 nm (OD490)		IVIS	Mean IVIS	Proposed in vitro Irritancy Score
		Mean		Mean
Negative control	-1	-0.33	0.082	0.068	0.23	0.69	Not categorized
	0		0.065		0.98
	0		0.058		0.87
Positive control	55.33		1.348		70.55	79.37	Category 1
	67.33		1.395		88.25
	53.33		1.731		79.25
Test item	0.33		0		0.33	0.23	Not categorized
	0.33		-0.006		0.24
	0.33		-0.014		0.12

Opacity and permeability values of positive control and the test substance are shown as corrected values.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

From the results of the in vitro BCOP study it was concluded that the test substance is not to be categorized.

Executive summary:

An in vitro study with fresh bovine cornea was conducted according to OECD 437 to investigate the eye irritation properties of the test substance. After a first opacity measurement of the fresh bovine corneae (t0), the neat test item, the positive and the negative controls were applied to corneae and incubated for 10 minutes at 32 ± 1 °C. After the incubation phase the substances were rinsed from the corneae. The corneae were incubated for another 120 minutes at 32 ± 1 °C in incubation medium, and opacity was measured a second time (t130). After the opacity measurements permeability of the corneae was determined by measuring spectrophotometrically the transfer of sodium fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C. With the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed (mean IVIS = 0.69). The positive control (2-Ethoxyethanol) was tested undiluted and showed clear opacity and distinctive permeability of the corneae (mean IVIS = 79.37) corresponding to a classification as serious eye damaging (CLP Cat 1). The test item was tested undiluted. Relative to the negative control, the test item did not cause an increase of the corneal opacity or permeability. The calculated mean IVIS was 0.23 (threshold for serious eye damage: IVIS≥55). According to OECD 437 the test item is not categorized.