Hydrocarbons, C4-7, C5-rich, isoprene-purifn. by-product

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD 437 study performed under GLP condititions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: BCOP OECD 437

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Absorbent A4

IUPAC Name:

Absorbent A4

Details on test material:

- Name of test material (as cited in study report): Absorbent A4
- Substance type: UVCB
- Physical state: Transparent liquid without mechanical impurities, colour from light to dark
- Stability under test conditions: months
- Storage condition of test material: room temperature, in the dark

Test animals / tissue source

Species:

other: Freshly isolated bovine cornea

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Duration of treatment / exposure:

10 minutes of incubation

Number of animals or in vitro replicates:

Number of Corneae per Group: 3
Number of Test Item Group: 1
Number of Negative Control Groups: 1
Number of Positive Control Groups: 1

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: after 10 minutes incubation time

Score:

0

Max. score:

0.17

Any other information on results incl. tables

Table of Results

Results after 10 Minutes Incubation Time

Test Group	Opacity value = Difference (t130-t0) of Opacity		Permeability at 490 nm (OD490)		In vitroScore	Meanin vitroScore	Proposedin vitroIrritation Scale
		Mean		Mean
Negative Control	- 1	- 0.67	0.252	0.159	2.78	1.71	Non eye irritant
	0		0.069		1.04
	- 1		0.155		1.33
Positive Control	38.67*		0.010*		38.82	46.13	Moderate eye irritant
	34.67*		0.292*		39.05
	52.67*		0.522*		60.50
Absorbent A4	0.67*		- 0.109*		- 0.96	0.00	Non eye irritant
	1.67*		- 0.100*		0.17
	1.67*		- 0.111*		0.01

*corrected values

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: According to the INVITTOX (UK) protocol no. 98

Conclusions:

In conclusion, according to the current study and under the experimental conditions reported, the test item Absorbent A4 is not corrosive to the eye (EU CLP/GHS (cat. 1; H318)). Corresponding to the INVITTOX (UK) protocol no. 98 classification Absorbent A4 is non eye irritant.

Executive summary:

This in vitro study was performed to assess thecorneal irritation and damage potential of Absorbent A4 by means of the BCOP assay using fresh bovine corneae.

The test item was tested undiluted. The positive control 2-Ethoxyethanol was tested neat. Saline was used as negative control item.

After a first opacity measurement of the fresh bovine corneae (t₀), the neat test item Absorbent A4, the positive, and the negative controls were applied to corneae and incubated for 10 minutes at 32 ± 1 °C in complete medium. After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae. Further, the corneae wereincubated for another 120 minutes at 32 ± 1 °C in complete medium, andopacity was measured a second time (t₁₃₀).

After the opacity measurements permeability of the corneae was determined by measuring spectrophotometrically the transfer of 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 in vitro score 1.71).

The positive control (2-Ethoxyethanol) caused clear opacity and permeability effects on the corneae (mean in vitro score 46.13) corresponding to a classification as moderate irritating to the eye according to the INVITTOX (UK) protocol no. 98.

Relative to the negative control, the test item Absorbent A4 did not cause any increase of the corneal opacity of permeability. The calculated mean in vitro score was 0.00. According to the INVITTOX (UK) protocol no. 98 the test item is classified as non eye irritant.