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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:
2012-10-29 to 2012-11-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Germany
- Age at study initiation: ca. 14 weeks old
- Weight at study initiation: >2kg
- Housing: plastic rabbit cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml


The test item was gently warmed in a water bath at 32 °C for liquid application.

Duration of treatment / exposure:
single instillation,
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
The test item was applied at a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for about 1 second in order to prevent loss of the material. The untreated contralateral eye served as control.
The treated eye was not rinsed 24 hours after the application.

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
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
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
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
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Remarks on result:
no indication of irritation
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
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
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
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Remarks on result:
no indication of irritation
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
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
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:
After the application into the eyes of three female NZW rabbits the test item produced slightly irritant but no corrosive effects.
Upon fluorescein examinations at the end of the observation period of 72 hours no corneal lesions were found in any animal.
Conjunctival redness and discharge were observed in all animals.
Other effects:
Neither mortalities nor significant clinical signs of toxicity were observed.

Any other information on results incl. tables

Table:  Eye Irritation Scores – Animal No. 1

Animal No. 1

Single Data

 

Time Post-Application

Average Score
(24, 48 and 72 hours)

1 hour

24 hours

48 hours

72 hours

T/C

T/C

T/C

T/C

Conjunctival Redness

1/0

1/0

1/0

0/0

0.67

Conjunctival Chemosis

0/0

0/0

0/0

0/0

0

Iris

0/0

0/0

0/0

0/0

0

Cornea

0/0

0/0

0/0

0/0

0

T =test item,     C = control

Table:  Eye Irritation Scores – Animal No. 2

Animal No. 2

Single Data

 

Time Post-Application

Average Score
(24, 48 and 72 hours)

1 hour

24 hours

48 hours

72 hours

T/C

T/C

T/C

T/C

Conjunctival Redness

1/0

1/0

1/0

0/0

0.67

Conjunctival Chemosis

0/0

0/0

0/0

0/0

0

Iris

0/0

0/0

0/0

0/0

0

Cornea

0/0

0/0

0/0

0/0

0

T =test item,     C = control

 

Table:  Eye Irritation Scores – Animal No. 3

Animal No. 3

Single Data

 

Time Post-Application

Average Score

(24, 48 and 72 hours)

1 hour

24 hours

48 hours

72 hours

T/C

T/C

T/C

T/C

Conjunctival Redness

1/0

1/0

1/0

0/0

0.67

Conjunctival Chemosis

0/0

0/0

0/0

0/0

0

Iris

0/0

0/0

0/0

0/0

0

Cornea

0/0

0/0

0/0

0/0

0

T =test item,     C = control

Table:  Clinical Signs of Toxicity

Animal No. 1

Time after
Test Item Application

Systemic Findings

Local Findings
(apart from findings in Table 3)

1 hour

nsf

discharge grade 1

24 hours

nsf

nsf

48 hours

nsf

nsf

72 hours

nsf

nsf

Animal No. 2

Time after
Test Item Application

Systemic Findings

Local Findings
(apart from findings in Table 4)

1 hour

nsf

discharge grade 2

24 hours

nsf

discharge grade 1

48 hours

nsf

nsf

72 hours

nsf

nsf

Animal No. 3

Time after
Test Item Application

Systemic Findings

Local Findings
(apart from findings in Table 5)

1 hour

nsf

discharge grade 2

24 hours

nsf

nsf

48 hours

nsf

nsf

72 hours

nsf

nsf

nsf: no specific findings

Table:  Absolute Body Weights in kg

 

Animal No. 1

Animal No. 2

Animal No. 3

Start of Study
(weight in kg)

3.1

3.1

3.0

End of Study
(weight in kg)

3.2

3.2

3.1

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No irritant effects to rabbit eyes were observed in a study conducted according to current OECD guideline and under GLP.