Registration Dossier

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
Study period:
2013-01-28 to 2013-02-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study; GLP study without deviation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
2008
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
1998
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Purity: >99%

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: 
- Source: LPT, Laboratory of Pharmacology and Toxicology, Löhndorf (Germany)
- Sex: female
- Age: approx. 4.5 to 5.5 months
- Weight at study initiation: 2.4 kg up to 2.7 kg
- Housing: single
- Diet: ad libitum, ssniff K-H (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water: ad libitum, tap water
- Acclimatisation period: at least 20 days
- Controls: identical animal, second eye
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3 °C
- Humidity (%): 30% - 70%
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: identical animal, left eye
Amount / concentration applied:
Amount: 0.1 mL of the test item was administered per eye

Duration of treatment / exposure:
Single instillation into the conjunctival sac of the right eye, test item was not rinsed
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
ADMINISTRATION: The test was performed initially using one animal. As no corrosive or severe irritant effects were observed in this animal, 2 further
animals were employed 24 hours after start of the initial test.
0.1 mL of the test item was administered per eye and tested in three animals.
The test item was placed into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were
then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control.
REMOVAL OF TEST SUBSTANCE
- Washing: test item was not rinsed
TOOL USED TO ASSESS SCORE: eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48 and 72 hours after the administration. The eye reactions were observed and registered.
At 24 hours after the administration, the eyes were treated additionally with fluorescein and examined.
SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjunctivae (Redness): 0
- Conjunctivae (Chemosis): 0
Other effects:
no other effects

Any other information on results incl. tables

Acute eye irritation/corrosion test of the test item

 

Examination of the treated eye

Time after

administration

C O R N E A

I R I S

C O N J U N C T I V A E

 

Opacity

 

Redness#

Chemosis##

 

A n i m a l n o. : 1 / 2 / 3

 

 

 

 

 

right eye: 100 ml test item

 

 

 

 

 

before dosing

0/0/0

0/0/0

0/0/0

0/0/0

 

 

 

 

 

1 hour

0/0/0

0/0/0

0/0/0

0/0/0

 

 

 

 

 

24 hours

0/0/0

0/0/0

0/0/0

0/0/0

 

 

 

 

 

48 hours

0/0/0

0/0/0

0/0/0

0/0/0

 

 

 

 

 

72 hours

0/0/0

0/0/0

0/0/0

0/0/0

 

 

 

 

 

Applicant's summary and conclusion

Conclusions:
The test substance was n o n - i r r i t a t i n g to eyes, hence, no labelling is required.
Executive summary:

The purpose of this study was to obtain information on the influence of the test item on rabbit eyes (irritation/corrosion test), according to OECD guideline 405, EC method B.5. and OCSPP guideline 870.2400.

Under the present test conditions a single administration of the test item per animal into the conjunctival sac of the right eye of three rabbits did not cause any changes.

Conjunctival redness, corneaeandirises were not affected by instillation of the test item. There were no systemic intolerance reactions.Therefore, according to the EC Regulatiom 1272/2008 and subsequent regulations on classification, labelling and packaging of substances and mixtures, the test item is non-irritating to eyes, hence, no labelling is required.