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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:
25 March 1985 to 11 June 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

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

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute Someren, The Netherlands
- Weight at study initiation: 2761 - 3000 g
- Housing: individually in Lurane cages with perforated floors
- Diet: standard diet ( LK01 Hope Farms Woerden) 100 g/d
- Water: tap water ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 °C
- Humidity (%): 50-80%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
grounded before instillation
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 64 mg (0.1 mL)

VEHICLE: none
Duration of treatment / exposure:
NA
Observation period (in vivo):
at 1, 24, 48 and 72 hours and 7 and 14 days after instillation
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: at 24 and 48 h fluorescein staining was used

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: superficial epithelial corrosion of the cornea (10-20%) at 24 h after fluorescein treatment
Remarks:
no corneal damage at 72 h
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
1
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
1.4
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.4
Max. score:
3
Reversibility:
fully reversible within: 7 days

Any other information on results incl. tables

Animal no

1

2

3

1

24

48

72

7

14

1

24

48

72

7

14

1

24

48

72

7

14

cornea

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

iris

1

0

0

0

0

0

1

0

0

0

0

0

1

1

0

0

0

0

conjunctivae

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

redness

1

1

2

2

1

0

1

2

1

1

1

0

1

2

2

1

1

0

chemosis

3

2

2

1

0

0

2

2

1

1

0

0

3

2

1

1

0

0

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is considered non-irritant to the eyes
Executive summary:

Three female rabbits received 64 mg (0.1 mL) of the substance in the eye. The eyes were observed for signs of irritation after 1, 24, 48 and 72 hours and after 7 and 14 days. No effects were found on the cornea and the iris. The effects on the conjunctivae were limited and fully reversible. The substance is considered not irritating to the eyes.