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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
Study predates requirements to perform in vitro screening ahead of in vivo studies.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 18 April to 09 May 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study run to a method comparable with current guidelines and to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: > 99.5 %Batch No.: not specified

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. - Age at study initiation: Adult- Weight at study initiation: No.4487: 3444 g, No. 4507: 3020 g, No.4509: 2748 g- Housing: Individually housed in a plastic cage with a perforated floor.- Diet (e.g. ad libitum): Standard laboratory animal diet - Water (e.g. ad libitum): Had free access to tap-water- Acclimation period: At least five days ENVIRONMENTAL CONDITIONS- Temperature (°C): 19 - 22°C- Humidity (%): 45 - 95 %- Air changes (per hr): The room was air conditioned.- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs lightIN-LIFE DATES: From 18 April To 09 May 1988

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): Approximately equivalent to 0.1 mL, by bulk density determination- Concentration (if solution):VEHICLE- Amount(s) applied (volume or weight with unit):- Concentration (if solution):- Lot/batch no. (if required):- Purity:
Duration of treatment / exposure:
21 days
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
Three
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done):- Time after start of exposure:SCORING SYSTEM: Draize scoreTOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
ca. 1.56
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: One animal was reversible with 7 days and two were not reversible within 21 days.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
ca. 0.44
Max. score:
2
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: One animal was not irritated, one animal was reversible within 3 days, and one animal was not reversible within 21 days.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
ca. 3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: All the three animals were not reversible within 21 days.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
ca. 1.78
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Two animals were not reversible with 21 days and one was reversible within 14 days.
Irritant / corrosive response data:
Instillation of approximately 77 mg of the test substance in one of the eyes of each of three albino rabbits resulted in adverse effects on the cornea, iris and conjunctivae. Approximately 60 minutes after exposure, one animal showed translucent areas of corneal opacity and iridial injection and no reaction to light, while in the other two animals slight cornea1 opacity was observed. All three animals also showed slight conjunctival redness and moderate chemosis. The corneal opacity noted in the first animal increased to nacreous areas, persistent during the following three days, while translucent areas of opacity were again observed on days 7, 14 and 21. Slight corneal opacity noted in a second animal persisted to the end of the study and in the third animal, the opacity resolved between days 3 and 7. The iridial injection noted in the first animal persisted at least to day 14, while on day 14 also no reaction to light could observed. A second animal showed injection of the iris on day 2. The conjunctival redness noted in all three animals increased to severe with a white/grey discolouration. This persisted in two animals to day 21 and in the third anima 1 to day 7, although slight redness was still observed on day 21. The moderate chemosis noted in all three animals decreased slowly, but had not resolved completely in two animals at the end of the study. The chemosis noted in a third animal resolved between days 7 and 14.
Other effects:
No signs of systemic intoxication were observed in any of the rabbits.

Any other information on results incl. tables

Eye irritation scores for test substance

Rabbit No., Sex and BW

Observations

Cornea

Iris

Conjunctivae

Opacity

 

 

redness

chemosis

discharge

 

(0-4)

(0-2)

(0-3)

(0-4)

(0-3)

4487

F

3444g

60min

1

0

1

3

1

1 day

0

0

3

2

1

2 day

1

0

3

1

2

3 day

1

0

3

2

1

7 day

0

0

3

1

0

14 day

0

0

1

0

0

21 day

0

0

1

0

0

4507

F

3020g

60min

1

0

1

3

1

1 day

1

0

3

2

1

2 day

1

1

3

2

1

3 day

1

0

3

2

1

7 day

1

0

3

2

1

14 day

1

0

3

1

0

21 day

1

0

3

1

0

4509

F

2748g

60min

2

2

1

3

1

1 day

3

1

3

2

1

2 day

3

1

3

2

2

3 day

3

1

3

1

2

7 day

2

1

3

2

2

14 day

2

2

3

1

0

21 day

2

-

3

1

1

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was severely irritating to rabbits eyes under the conditions of the test.
Executive summary:

The study was conducted according to EU Method B.5 under GLP using three New Zealand White rabbits.

The test substance was severely irritating to rabbits eyes under the conditions of the test.