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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
Study period:
From 11 May 2016 to 17 May 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: provided by Sponsor
- Expiration date of the lot/batch: 15 March 2017
- Purity: 45.4% active ingredient in water solution
- Colour: light yellow

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigerator (2-8°C).
The substance is deemed to be stable.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Preliminary purification step (if any): Water solution provided by Sponsor was Freeze-dried to produce the dry Test Item used in this study. Considered as 100%

FORM AS APPLIED IN THE TEST: the dry Test Item was used in the study (solid)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: S&K-LAP Kft. 2173 Kartal, Császár út 135, Hungary- Age at study initiation: 14 weeks old (male young adult)- Weight at study initiation: 3222 g – 3929 g- Housing: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.- Diet: ad libitum- Water: ad libitum- Acclimation period: at least 28 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20.0 – 24.0°C- Humidity (%): 28 – 68 %- Air changes (per hr): 15-20 air exchanges/hour- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.IN-LIFE DATES: From: 11 May 2016 To: 14 May 2016

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 g of test item
Duration of treatment / exposure:
The test substance was placed in the conjunctival sac. The treated eye of test animals was not rinsed with physiological saline solution, test item remained in the eye sac at the one hour observation time point
Observation period (in vivo):
The eyes were examined at 1, 24, 48 and 72 hours after treatment.
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE - Washing (if done): no washing was conducted. SCORING SYSTEM: The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (02 October 2012) TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Irritant / corrosive response data:
The test item, applied to rabbit eye mucosa, caused conjunctival effects at one hour after application which were fully reversible within 48 hours.
Other effects:
- Lesions and clinical observations:No Initial Pain Reaction (IPR) or any Pain Reaction (PR) was observed during the experimental period.Animal 1 clinical observations:At one hour after the application, conjunctival redness (score 1), chemosis (score 1) and discharge (score 1) were noted in the rabbit. Test item did not remain in the eye sac.At 24 hours after the application, conjunctival redness (score 1) was noted in the rabbit.At 48 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.At 72 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.Animal 2 clinical observations:At one hour after the application, conjunctival redness (score 1), chemosis (score 1) and discharge (score 1) were noted in the rabbit. Test item did not remain in the eye sac.At 24 hours after the application, conjunctival redness (score 1) was noted in the rabbit.At 48 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.At 72 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.Animal 3 clinical observations:At one hour after the application, conjunctival redness (score 1), chemosis (score 1) and discharge (score 1) were noted in the rabbit. Test item did not remain in the eye sac.At 24 hours after the application, conjunctival redness (score 1) was noted in the rabbit.At 48 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.At 72 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.- Other observations: The general state and behaviour of animals were normal throughout the study period. No mortality occurred during the study. The body weights of all rabbits were considered to be within the normal range of variability.

Any other information on results incl. tables

INDIVIDUAL SCORES FOR OCULAR IRRITATION

Animal Number

Sex

Cornea Opacity

Iris

Conjunctivae

Redness

Chemosis

Discharge

811
Animal 1

male

0.00

0.00

0.33

0.00

0.00

813
Animal 2

male

0.00

0.00

0.33

0.00

0.00

828
Animal 3

male

0.00

0.00

0.33

0.00

0.00

Animal 1

Time

Score of irritation

IPR/ PR

Other sign

Conjunctivae

Cornea

Iris


Control eye

R

CH

D

OD

OE

R

Pre- treatment

0

0

0

0

0

0

0

0

0

Post-treatment
(h =hour)

1 h

1

1

1

0

0

0

0

0

0

24 h

1

0

0

0

0

0

0

0

0

48 h

0

0

0

0

0

0

0

0

0

72 h

0

0

0

0

0

0

0

0

0

Animal 2

Time

Score of irritation

IPR/ PR

Other sign

Conjunctivae

Cornea

Iris


Control eye

R

CH

D

OD

OE

R

Pre- treatment

0

0

0

0

0

0

0

0

0

Post-treatment
(h =hour)

1 h

1

1

1

0

0

0

0

0

0

24 h

1

0

0

0

0

0

0

0

0

48 h

0

0

0

0

0

0

0

0

0

72 h

0

0

0

0

0

0

0

0

0

Animal 3

Time

Score of irritation

IPR/ PR

Other sign

Conjunctivae

Cornea

Iris


Control eye

R

CH

D

OD

OE

R

Pre- treatment

0

0

0

0

0

0

0

0

0

Post-treatment
(h =hour)

1 h

1

1

1

0

0

0

0

0

0

24 h

1

0

0

0

0

0

0

0

0

48 h

0

0

0

0

0

0

0

0

0

72 h

0

0

0

0

0

0

0

0

0

Abbreviations:  R = Redness                OD = Opacity degree of density

CH = Chemosis               OE        = Extent of opaque area

D = Discharge                 IPR/PR = Initial or any pain reaction

0    = Normal (in case of control eye and other lesions)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under these experimental conditions, the test item does not require classification as an eye irritant.
Executive summary:

The eye irritation potential of the test item was determined in accordance with the OECD Nº 405 with GLP. The test item was applied on three New Zealand male White rabbits (0.1g/eye). Animals were observed at 1h, 24h, 48 and 72h after the test item was applied. The corneal opacity score, the iris score and the conjunctive score (Discharge, Redness and Chemosis) were evaluated. No Initial Pain Reaction (IPR) or any Pain Reaction (PR) was observed during the experimental period. The test item, applied to rabbit eye mucosa, caused conjunctival effects at one hour after application which were fully reversible within 48 hours.The mean chemosis score, mean discharge score, mean cornea score and mean iris score were all 0.0, whereas the mean redness score was 0.33.According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, the test item does not require classification as an eye irritant.