Bis(α,α-dimethylbenzyl) peroxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-12-10 to 2010-02-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

24 April 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Bis(α,α-dimethylbenzyl) peroxide

EC Number:

201-279-3

EC Name:

Bis(α,α-dimethylbenzyl) peroxide

Cas Number:

80-43-3

Molecular formula:

C18H22O2

IUPAC Name:

1,1'-(dioxydipropane-2,2-diyl)dibenzene

Details on test material:

- Name of test material (as cited in study report): Dicumylperoxide
- Molecular formula (if other than submission substance): C18H22O2
- Substance type: white crystalline powder
- Physical state: solid
- Analytical purity: 99.5% (based on CoA)
- Purity test date: 07.12.2009
- Lot/batch No.: 44229 (receipt no.)

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: LPT breeding station Löhndorf, Germany
- Age at study initiation: 6.5–7.5 months
- Weight at study initiation: 2.4, 2.7, and 3.0 kg
- Housing: single
- Diet (e.g. ad libitum): ssniff K-H V2333, ssniff Spezialdiäten GmbH, Soest; ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 20 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30–70 %
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of mortared test iteminto one eye

Duration of treatment / exposure:

1 h

Observation period (in vivo):

1 d test, 72 h follow-up period

Number of animals or in vitro replicates:

3 (test was initially performed using 1 animal; as no corrosive or servere irritant effects were observed, 2 further animals were employed 24 after start of first initial test)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with 20mL 0.9% NaCl solution
- Time after start of exposure: 1h

SCORING SYSTEM: cornea: max. score 4, iris: max. score 2, conjunctivae: max. score 3, chemosis: max. score 4 (for specification of score see test report)

TOOL USED TO ASSESS SCORE: Hand-slit lamp and fluorescein

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:

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 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.6

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

chemosis 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 #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 11

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 12

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

Irritant / corrosive response data:

Corneal opacity (grade 1) was observed in animal no. 3 twenty-four and fourty-eight hours after instillation. The fluorescein test performed twenty-four hours after instillation revealed corneal staining in animal no. 3 (up to 1/4 of the surface). Conjunctival redness (grade 1) was observed in all animals 60 minutes, in animals nos. 2 and 3 until twenty-four hours after instillation. The irises were not affected by instillation of the test item.

Other effects:

There were no systemic intolerance reactions.

Any other information on results incl. tables

Table 1: Effects of 100 mg dicumylperoxide in the right rabbit eye

	Cornea	Iris	Conjunctivae
	Opacity		Redness#	Chemosis##
		animal no.: 1/2/3
Before dosing	0/0/0	0/0/0	0/0/0	0/0/0
60 min	0/0/0	0/0/0	1/1/1	0/0/0
24h	0/0/1	0/0/0	0/1/1	0/0/0
48h	0/0/1	0/0/0	0/0/0	0/0/0
72h	0/0/0	0/0/0	0/0/0	0/0/0

# refers to palpebral and bulbar conjunctivae; excluding cornea and iris

## swelling: refers to lids and/or nictating membrane

left eye: untreated control, all scores 0/0/0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the result of the study the substance was not irritating when tested on rabbit eye.

Executive summary:

In a primary eye irritation study (OECD 405), 0.1 g of the test item was instilled into the conjunctival sac of one eye of each of three young adult Himalayan rabbits. Animals were observed for 14 days. Irritation was scored by the method of Draize. The behaviour and physical state of the rabbits, and the body-weight evolution were normal throughout the study. Only very mild conjunctival and corneal opacity reactions were observed, which were fully reversible within 72 hours. Based on the results, the test item can be considered as not irritating.