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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
LPT Laboratory of Pharmacology and Toxicology GmbH

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 m
- Weight at study initiation: 2.4, 2.7, and 3.0 kg
- Housing: singly
- 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
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
13
Reversibility:
fully reversible
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

Effects of 100 mg dicumylperoxide in 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

24 h fluorescein test: animal no. 3: corneal staining (up to 1/4 of the surface)

 

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

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the result of the study the substance was not irritating when tested on rabbit eye.
Executive summary:

Dicumyl peroxide was tested at 100 mg in rabbit eye. The overall irriation score was 0 of max. 13 after 72 h. The effects observed after 24 and 48 h (all grade 1 for cornea opacity and conjunctivae redness) were fully reversible after 72h.