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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:
05 Feb - 28 June 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no data on purity available
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Y-11542
- Physical state: clear, colourless, slightly viscous liquid
- Analytical purity: no data available
- Lot/batch No.: 2131UG060495
- Storage condition of test material: original container at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Inc., Denver, PA, USA
- Age at study initiation: young adult
- Weight at study initiation: 2425 - 3073 g
- Fasting period before study: no
- Housing: individually housed in mesh-bottom cages
- Diet: Purina Certified Rabbit Chow No. 5322, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.8-20.2
- Humidity (%): 35.0-42.6
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml
Duration of treatment / exposure:
single instillation without washing
Observation period (in vivo):
4 days
Reading time points: 1, 24, 48 and 72 h and 4 days
Number of animals or in vitro replicates:
6 (3 males, 3 females)
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-held penlight / fluorescein (UV light)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: mean of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
other: mean of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
other: mean of all 6 animals
Time point:
24/48/72 h
Score:
0.61
Max. score:
3
Reversibility:
fully reversible within: 4 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
other: mean of all 6 animals
Time point:
24/48/72 h
Score:
0.06
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No effects on cornea or iris were observed in any animal at any time point. Slight conjuntivae redness (grade 1-2) was observed in every animal 1 h after instillation of test item and were fully reversible within 4 days. Chemosis (grade 1) was observed in every animal 1 h after instillation of test substance and was fully reversible within 48 h. Clear discharge was observed in 1 animal 1 h after instillation of test substance but was fully reversible within 24 h.
Other effects:
No signs of systemic toxicity or effects on body weight gain were observed.

Any other information on results incl. tables

Table 1: Individual scores from eye irritation study in male rabbits.

Rabbit #

(males) 

Time [h]

 

conjunctivae

 

iris

 

cornea

 

redness

swelling

1

 

 

 

 

1

2

1

0

0

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

(over 24, 48, 72 h)

0.33

0

0

0

2

 

 

 

 

1

2

1

0

0

24

1

0

0

0

48

1

0

0

0

72

1

0

0

0

96

0

0

0

0

average

(over 24, 48, 72 h)

1.00

0

0

0

3

 

 

 

 

1

1

1

0

0

24

1

0

0

0

48

1

0

0

0

72

1

0

0

0

96

0

0

0

0

average

(over 24, 48, 72 h)

1.00

0

0

0

 

 

Table 2: Individual scores from eye irritation study in female rabbits.

Rabbit #

(females) 

Time [h]

 

conjunctivae

 

iris

 

cornea

 

redness

swelling

1

 

 

 

 

1

1

1

0

0

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

(over 24, 48, 72 h)

0.33

0

0

0

2

 

 

 

 

1

2

1

0

0

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

96

0

0

0

0

average

(over 24, 48, 72 h)

0.33

0

0

0

3

 

 

 

 

1

2

1

0

0

24

1

1

0

0

48

1

0

0

0

72

0

0

0

0

96

0

0

0

0

average

(over 24, 48, 72 h)

0.66

0.33

0

0

 

 

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
In an eye irritation study according to OECD 405 the substance was found to be not irritating to eyes. Treatment of 3 female and 3 male New Zealand White rabbits with 0.1 ml undiluted test substance resulted in no effects on cornea and iris in any animal at any time point. Slight conjuntivae redness (grade 1-2) was observed in every animal 1 h after instillation of test item and were fully reversible within 4 days. Chemosis (grade 1) was observed in every animal 1 h after instillation of test substance and was fully reversible within 48 h. Clear discharge was observed in 1 animal 1 h after instillation of test substance but was fully reversible within 24 h.