1-methyl-1-phenylethyl peroxyneodecanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998-06-30 to 1998-12-31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

24 February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

31 July 1992

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-methyl-1-phenylethyl peroxyneodecanoate

EC Number:

247-956-7

EC Name:

1-methyl-1-phenylethyl peroxyneodecanoate

Cas Number:

26748-47-0

Molecular formula:

C19H30O3

IUPAC Name:

1-methyl-1-phenylethyl 2-ethyl-2,5-dimethylhexaneperoxoate

Specific details on test material used for the study:

TEST MATERIAL
- Name: Peroxyneodecanoate de cumyle
- CAS No.: 26748-47-0
- Brand name: LUPEROX 188 M 70
- Batch No.: XX200001
- Appearance: colourless liquid
- Purity: 75.6% in isododecane
- Origin: Laporte Organics-Peroxide-Chemie
- Storage: - 20 °C, protected from light
- Expiry date: September 1998

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Weight at study initiation: 2.3 +/- 0.3 kg
- Number per sex: 3 male
- Housing: individually, polystyrene cages (35 cm x 55 cm x 32 cm or 48.2 cm x 58 cm x 36.5 cm)
- Diet: ad libitum; 112 C pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France)
- Water: ad libitum; drinking water filtered by FG Millipore membrane (0.22 micron)
- Acclimatisation period: At least 5 days
- Identification: metal tag in the ear

ENVIRONMENTAL CONDITIONS
- Temperature: 18 +/- 3 °C
- Humidity: 30 - 70 %
- Air changes: 12 cycles/hour, filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

once; eyes were not rinsed after administration

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3 male rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were not rinsed after administration of the test substance.
SCORING SYSTEM: Scoring according to the method of Draize (see Table 1 in box ‘Any other information on materials & methods incl. tables’).
TOOL USED TO ASSESS SCORE: Cornea: direct examination or, if necessary, with an Ultra-Violet lamp
To determine the presence or absence of corneal opacification and to evaluate the affected area, one or two drops of 0.5% sodium fluorescein solution can be instilled into the eye (however, this must not be performed before the 24-hour reading). If corneal opacification is difficult to determine, the eye can be examined under a UV lamp (a clear fluorescence is visible in the areas of opacification).
As possible irritant effects were anticipated, the test substance was evaluated in one animal in a first assay. Since the test substance was not severely irritant in this first assay, it was evaluated in a second assay on two other animals.
A single dose of 0.1 mL of the undiluted test substance was instilled into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball.
The lower and upper eyelids were held together for about one second to avoid any loss of the test substance. The right eye, which remained untreated, served as control.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Only very slight or slight conjunctival reactions (very slight or slight chemosis and very slight redness of the conjunctiva) were observed in all animals which were fully reversible within 72 hours at the latest.

Any other information on results incl. tables

Table 2: Individual ocular examinations and mean values of the scores recorded at each reading (24, 48 and 72 hours) for each animal

Rabbit number	Region of eye	Description of ocular reactions	Scores				Mean irritation score (1)	Interpretation (+) (-)
			1h D1	24h D2	48h D3	72h D4
01	Conjunctivae	Chemosis	2	1	0	0	0.3	(-)
		Redness	1	1	1	0	0.7	(-)
		Discharge	0	0	0	0	0.0
	Iris		0	0	0	0	0.0	(-)
	Corneal opacity	Intensity	0	0	0	0	0.0	(-)
		Area	0	0	0	0	0.0
	Other		*	*	*	*
	Fluorescein		/	U	/	/
02	Conjunctivae	Chemosis	1	1	0	0	0.3	(-)
		Redness	1	1	0	0	0.3	(-)
		Discharge	0	0	0	0	0.0
	Iris		0	0	0	0	0.0	(-)
	Corneal opacity	Intensity	0	0	0	0	0.0	(-)
		Area	0	0	0	0	0.0
	Other		*	*	*	*
	Fluorescein		/	U	/	/
03	Conjunctivae	Chemosis	1	1	1	0	0.7	(-)
		Redness	1	1	1	0	0.7	(-)
		Discharge	0	0	0	0	0.0
	Iris		0	0	0	0	0.0	(-)
	Corneal opacity	Intensity	0	0	0	0	0.0	(-)
		Area	0	0	0	0	0.0
	Other		*	*	*	*
	Fluorescein		/	U	/	/

(1) mean of scores on days 2, 3 and 4

h = hour

D = day

(+) = irritant according to E.E.C. criteria

(-) = non-irritant according to E.E.C. criteria

* = None

U = Flourescein batch No. 9809

/ = Fluorescein not used

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under experimental conditions, the test substance LUPEROX 188 M 70 (batch No. XX200001) is non-irritant to the eyes of rabbits.

Executive summary:

In a primary eye irritation study according to OECD 405, 0.1 mL of 1 -Methyl-1-phenylethyl peroxyneodecanoate (75.6 % purity) was instilled into the conjunctival sac of one eye of three male New Zealand White Rabbits (approx. 2.3 kg). Animals were observed for 72 hours with examination at 24, 48 and 72 h after test substance administration. Eye lesions were scored by the method of Draize. Only very slight or slight conjunctival reactions (very slight or slight chemosis and very slight redness of the conjunctiva) were observed in all animals which were fully reversible within 72 hours at the latest.

Under the conditions of the present study, a single ocular application of the test item to rabbits produced no adverse effects on cornea, iris or conjunctivae in any animal. No mortalities nor clinical signs of toxicity were observed.

In this study, 1 -Methyl-1-phenylethyl peroxyneodecanoate did not meet GHS criteria and was therefore considered non-irritant.