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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:
From 1990-10-31 to 1991-01-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991
Reference Type:
publication
Title:
Unnamed
Year:
1990
Reference Type:
review article or handbook
Title:
Sax's Dangerous Properties of Industrial Materials
Author:
Lewis
Year:
1995
Bibliographic source:
9th ed., Van Nostrand Reinhold, New York, page 3416, ref. JACTDZ 12, 629, 93

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: 16 CFR 1500.42
Deviations:
not specified
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
observation period limited to 72 h instead of 21 days; no observation at 1 h after instillation of the substance; in half of the rabbits the eyes were washed already after 30 seconds
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Yttrium trinitrate
EC Number:
233-802-6
EC Name:
Yttrium trinitrate
Cas Number:
10361-93-0
Molecular formula:
N3O9Y
IUPAC Name:
yttrium trinitrate
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Yttrium nitrate
- Substance type: Off-white crystalline/powdered solid
- Physical state: Solid
- Further information on test material confidential.

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, S. Brunswick, NJ, USA
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: Individually in suspended stainless steel caging with mesh floors.
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6-22.8°C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eyes served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g per treated eye
Duration of treatment / exposure:
The substance was placed in the conjunctival sac of the left eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about 1 second to prevent loss of the test material before releasing. The other eye of each rabbit remained untreated and served as a control.
Observation period (in vivo):
Ocular lesions were evaluated in accordance with Draize et al. at 24, 48 and 72 hours.
Number of animals or in vitro replicates:
6 (3 males, 3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Three of the treated eyes were rinsed with saline 30 seconds post-instillation. The remaining three eyes were not irrigated. The rabbits were restrained with neck collars and were returned to their respective cages for 24 hours.

SCORING SYSTEM: After instillation of the test material, ocular lesions were evaluated in accordance with Draize et al. at 24, 48 and 72 hours. 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.

MMTS: 0.0-0.5: Non-irritating
MMTS: 0.6 - 2.5: Practically non-irritating
MMTS: 2.6-15.0: Minimally irritating
MMTS: 15.1-25.0: Mildly irritating
MMTS: 25.1-50.0: Moderately irritating
MMTS: 50.1-80.0: Severly irritating
MMTS: 80.1-100.0: Extremely irritating
MMTS: 100.1-110.0: Maximally irritating
Maximum mean total score - Kay and Calandra, J. Soc. Cos. Chem. 13: 281-289 (1962). If more than 40% of the rabbits tested have scores > 10 or if an individual rabbits 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
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: unwashed eyes, mean value
Remarks:
24/48/72h: 2/2/2
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: unwashed eyes, mean value
Remarks:
24/48/72h: 1/1/1
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no corneal opacity observed at any time point
Remarks on result:
other: unwashed eyes, mean value
Remarks:
24/48/72h: 0/0/0
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no corneal opacity observed at any time point
Remarks on result:
other: washed eyes, mean value
Remarks:
24/48/72h: 0/0/0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: washed eyes, mean value
Remarks:
24/48/72h: 1/1/2
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no corneal opacity observed at any time point
Remarks on result:
other: washed eyes, mean value
Remarks:
24/48/72h: 0/0/0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: unwashed eyes, mean value
Remarks:
24/48/72h: 1/1/1
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: unwashed eyes, mean value
Remarks:
24/48/72h: 1/1/1
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: unwashed eyes, mean value
Remarks:
24/48/72h: 1/1/1
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: washed eyes, mean value
Remarks:
24/48/72h: 1/1/1
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: washed eyes, mean value
Remarks:
24/48/72h: 1/1/1
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: washed eyes, mean value
Remarks:
24/48/72h: 1/1/1
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: unwashed eyes, mean value
Remarks:
24/48/72h: 2/2/2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: unwashed eyes, mean value
Remarks:
24/48/72h: 2/2/2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: unwashed eyes, mean value
Remarks:
24/48/72h: 2/3/2
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: washed eyes, mean value
Remarks:
24/48/72h: 2/2/2
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: washed eyes, mean value
Remarks:
24/48/72h: 2/3/3
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: washed eyes, mean value
Remarks:
24/48/72h: 2/3/2
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: unwashed eyes, mean value
Remarks:
24/48/72h: 4/4/4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.67
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: unwashed eyes, mean value
Remarks:
24/48/72h: 4/4/3
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: unwashed eyes, mean value
Remarks:
24/48/72h: 3/3/1
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: washed eyes, mean value
Remarks:
24/48/72h: 3/3/3
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: washed eyes, mean value
Remarks:
24/48/72h: 3/4/3
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: washed eyes, mean value
Remarks:
24/48/72h: 3/3/1
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24 h
Score:
34
Max. score:
110
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: unwashed eyes
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24 h
Score:
27.7
Max. score:
110
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: washed eyes
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
48 h
Score:
37.7
Max. score:
110
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: unwashed eyes
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
48 h
Score:
29
Max. score:
110
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: washed eyes
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
72 h
Score:
30.7
Max. score:
110
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: unwashed eyes
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
72 h
Score:
29
Max. score:
110
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: washed eyes
Irritant / corrosive response data:
Corneal opacity was observed in 2 unwashed eyes and 1 washed eye at each scoring interval. Iritis and conjunctival irritation was observed in all treated eyes (unwashed and washed) at all scoring intervals. Based on the scoring system used, yttrium trinitrate is considered to be severely irritating to the unwashed and washed eyes when instilled as received, undiluted.
Other effects:
All animals appeared active and healthy. Apart from the eye irritation noted there were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Based on the scoring system used, yttrium trinitrate was observed to be severely irritating to the unwashed and washed eyes when instilled as received, undiluted. As no observation period of 21 days was taken into account, no definite conclusion on classification can be drawn. However, as the eye irritation effects were not reversible within the observation period in this test, the substance is classified for serious eye damage (eye damage category 1, H318) as worst case approach.