Bottom residues resulting from the synthesis of propylene oxide and styrene from epoxidation of propylene with ethylbenzene hydroperoxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 25 to May 10 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:

Bottom product of propylene oxide and styrene production

IUPAC Name:

Bottom product of propylene oxide and styrene production

Details on test material:

- Name of test material (as cited in study report): KORE grade V
- Substance type: UVCB
- Physical state: Brown viscous liquid
- Stability under test conditions: months
- Storage condition of test material: room temperature

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:

6.91

Max. score:

10.65

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 vitroIrritation Score	Meanin vitroIrritation Score	Proposedin vitroIrritation Scale
		Mean		Mean
Negative Control	0	0.33	0.055	0.074	0.83	1.44	Non eye irritant
	0		0.055		0.83
	1		0.112		2.68
Positive Control	47.67*		0.827*		60.07	56.68	Severe eye irritant
	42.67*		0.954*		56.98
	33.67*		1.288*		52.99
Bottom product of propylene oxide and styrene production	4.67*		- 0.007*		4.56	6.91	Mild eye irritant
	5.67*		- 0.011*		5.50
	7.67*		0.199*		10.65

*corrected values

Applicant's summary and conclusion

Interpretation of results:

other: mild eye irritant

Remarks:

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

Conclusions:

In conclusion, it can be stated that in this study and under the experimental conditions reported, according to the INVITTOX (UK) protocol no. 98 the test item is classified as mild eye irritant, corresponding to the GHS/EPA/CLP classification it is not corrosive to the eye.

Executive summary:

Thisin vitrostudy was performed to assess thecorneal irritation and damage potentialofBottom product of propylene oxide and styrene productionby means of the BCOP assay usingfresh 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 Bottom product of propylene oxide and styrene production, 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 (meanin vitroirritation score1.44).

The positive control (2-Ethoxyethanol) showed clear opacity and distinctive permeability of the corneae (meanin vitroirritation score 56.68) corresponding to a classification as corrosive to the eye (CLP/EPA/GHS (cat. 1; H318)).

Relative to the negative control, the test item Bottom product of propylene oxide and styrene production caused a slight increase of the corneal opacity. Permeability effects could not be observed. The calculated meanin vitroirritationscore was 6.91.