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Diss Factsheets

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:
1990-10-24 to 1990-11-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: FHSA 16 CFR 1500.42
Deviations:
not specified
Principles of method if other than guideline:
No further data.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Digadolinium trioxide
EC Number:
235-060-9
EC Name:
Digadolinium trioxide
Cas Number:
12064-62-9
Molecular formula:
Gd2O3
IUPAC Name:
Digadolinium trioxide
Test material form:
solid: particulate/powder
Details on test material:
- Identification: Lot #9
- Description: white powdered solid
- Date received: 1990-10-16

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, South Brunswick, NJ, USA
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: Individually housed in suspended stainless steel caging with mesh floors.
- Diet (e.g. ad libitum): ad libitum, Pelleted Purina Rabbit chow
- Water (e.g. ad libitum): ad libitum, tap water supplied by automatic watering system
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 66-76°F
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: 1990-12-31 To: 1991-01-03

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye of each animal remained untreated and served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Undiluted; 0.1 g was applied into the conjunctival sac of the right eye.
Duration of treatment / exposure:
30 seconds for 3 of the treated eyes (washed eyes) and up to 72 hours for the 3 others (the upper and lower lids were gently held together for about 1 second to prevent loss of the test material).
Observation period (in vivo):
72 hours (observation at 24, 48, and 72 hours after instillation)
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 3 of the treated eyes were rinsed with 30 mL saline 30 seconds post-instillation. The remaining three eyes were not irrigated.

SCORING SYSTEM: According to the method of Draize. The eye scores were further classified by the system of Kay and Calandra, Modified. Special care was taken to look for and notate any unusual effects, such as pannus, blistering of the conjunctivae, ulceration and other indicators of corrosive action.

The maximum mean total score (MMTS) was determined for both washed and unwashed eyes, and classification was determined as follows:
0.0-0.5 - non-irritating
0.6-2.5 - practically non-irritating
2.6-15.0 - minimally irritating
15.1-25.0 - mildly irritating
25.1-50.0 - moderately irritating
50.1 - 80.0 - severely irritating
80.1 - 100.0 - extremely irritating
100.1 - 110.0 - maximally irritating

If more than 40% of the rabbits tested have scores > 10 or if an individual rabbit score is > 30, the preliminary classification is raised to the next highest level.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1,2,3
Remarks:
unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal: 4,5,6
Remarks:
washed eye
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal: 1,2
Remarks:
unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal: 3
Remarks:
unwashed eye
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal: 4,5,6
Remarks:
washed eye
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal: 1,2
Remarks:
unwashed eye
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal: 3
Remarks:
unwashed eye
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks:
scores after 24, 48 and 72 h were 2, 1 and 1, respectively
Irritation parameter:
conjunctivae score
Basis:
animal: 4
Remarks:
washed eye
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal: 5
Remarks:
washed eye
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks:
scores after 24, 48 and 72 h were 1, 2 and 1, respectively
Irritation parameter:
conjunctivae score
Basis:
animal: 6
Remarks:
washed eye
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: 1,2
Remarks:
unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal: 3
Remarks:
unwashed eye
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks:
scores after 24, 48 and 72 h were 1, 1 and 1, respectively
Irritation parameter:
chemosis score
Basis:
animal: 4
Remarks:
washed eye
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: 5,6
Remarks:
washed eye
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
One unwashed and three washed eyes had iritis at 24 hours only. All animals had slight conjunctival irritation which had cleared from most treated eyes by 72 hours. No corneal opacity was noted during the study. The test material is considered to be minimally irritating to the unwashed eye and mildly irritating to the washed eye, when considering the Maximum Mean Total Scores.

Maximum Mean Total Score for washed eyes: 11.7
Maximum Mean total Score for unwashed eyes: 6.3

- mean of 3 rabbits / unwashed eyes at 24h: 6.3
- mean of 3 rabbits / unwashed eyes at 48h: 2.7
- mean of 3 rabbits / unwashed eyes at 72h: 1.3
- mean of 3 rabbits / washed eyes at 24h: 11.7
- mean of 3 rabbits / washed eyes at 48h: 4.0
- mean of 3 rabbits / washed eyes at 72h: 0.7

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material produced minimal irritation to both the unwashed and washed eyes. Based on the individual data for cornea opacity, iritis, conjunctival redness and chemosis, no classification of the test substance according to the CLP Regulation is required.