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EC number: 234-685-4 | CAS number: 12023-91-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-09-23 to 2010-09-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Data generated according to generally valid testing guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for the Testing of Chemicals: Isolated Chicken Eyes Test Method for Identifying Ocular Corrosives and Severe Irritants. Adopted: 7 Sep 2009. Following OECD 438.
- Deviations:
- yes
- Remarks:
- Minor deviations not impacting validity of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dodecairon strontium nonadecaoxide
- EC Number:
- 234-685-4
- EC Name:
- Dodecairon strontium nonadecaoxide
- Cas Number:
- 12023-91-5
- Molecular formula:
- Fe12O19.Sr
- IUPAC Name:
- dodecairon(3+) strontium(2+) nonadecaoxidandiide
- Details on test material:
- - Name of test material (as cited in study report): Strontiumhexaferrite ("Manipermpulver")
- Analytical purity: 100 % industrial strontiumferrite
- Impurities (identity and concentrations): see section 1.2 of the IUCLid5.2-file
- Composition of test material, percentage of components: see section 1.2 of the IUCLid5.2-file
- Lot/batch No.: S16/179/08
- Expiration date of the lot/batch: 12/2999
- Stability under test conditions: stable
- Storage condition of test material: air-conditioned romm temperature, non-sterile
Constituent 1
Test animals / tissue source
- Species:
- other: chicken, isolated eyes
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- Not applicable, as isolated eyes.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.03 mg per isolated eye
- Duration of treatment / exposure:
- 10 s
- Observation period (in vivo):
- 30 min, 75 min, 120 min, 180 min and 240 min
- Number of animals or in vitro replicates:
- 3 eyes for th test substance
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- Sample 01
- Value:
- 1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- Sample -02
- Value:
- 1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- Sample -03
- Value:
- 0.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Sample -01
- Value:
- 1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Sample -02
- Value:
- 1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Sample -03
- Value:
- 1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- No adverse morhological effect was observed in all the seven ICE During the observation period.
Any other information on results incl. tables
The fluorescein retention and corneal opacity of ICE before treatment:
ICE ID |
Flurorescein retention score before treatment |
Corneal opacity before treatment |
Additional damage |
Sample -01 |
0.5 |
0 |
No |
Sample -02 |
0.5 |
0.5 |
No |
Sample -03 |
0 |
0 |
No |
Positive control -01 |
0 |
0 |
No |
Positive control -02 |
0.5 |
0.5 |
No |
Positive control -03 |
0 |
0 |
No |
Negative control -01 |
0 |
0 |
No |
The fluorescein retention and corneal opacity of ICE after treatment:
ICE ID |
Flurorescein retention score 30 min after treatment |
Corneal opacity after treatment |
||||
30 min |
75 min |
120 min |
180 min |
240 min |
||
Sample -01 |
1 |
1 |
1 |
1 |
1 |
1 |
Sample -02 |
1 |
1 |
1 |
1 |
1 |
1 |
Sample -03 |
0.5 |
1 |
1 |
1 |
1 |
1 |
Positive control -01 |
1 |
3 |
3 |
3 |
3 |
3 |
Positive control -02 |
2 |
3 |
3 |
3 |
3 |
3 |
Positive control -03 |
2 |
3 |
3 |
3 |
3 |
3 |
Negative control -01 |
0.5 |
1 |
1 |
1 |
1 |
1 |
Observation of other adverse morphological effect:
No adverse morphological effect was observed in all the seven ICEs during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: OECD Guideline on this test
- Conclusions:
- Under the condition of this study strontium ferrite is not considered as ocular corrosive or severe irritant using Isolated Chicken Eye Test Method.
- Executive summary:
In-vitro eye irritation (and in-vitro eye corrosion) was tested by using isolated chicken eyes. The test guideline was "OECD Guideline for the Testing of Chemicals: Isolated Chicken Eyes Test Method for Identifying Ocular Corrosives and Severe Irritants. Adopted: 7 Sep 2009" which follows OECD Guideline 438.
The test substance strontium ferrite as well as a postive control (sodium hydroxide) and a negative control (0.9 % sodium chloride saline) were applied to isolated chicken eyes. The endponts evaluated were:
1. corneal opacity
2. fluorescein retention
3. adverse morphological effects.
Based on the results,
For the test substance strontium ferrite, the mean maximum opacity score after treatment is 1.0 (Class II); the mean fluorescein retention score at 30 min after treatment is 0.8 (Class II). No adverse morphological effect was observed in all the seven ICEs during the observation period. He
nce, the test substance is not considered as ocular corrosive or severe irritant.
For positive control substance, the mean maximum opacity score after treatment is 3.0 (Class IV); the mean fluorescein retention score at 30 min after treatment is 1.7 (Class III). The corneal opacity of all the three eyes was ≥2 at 30 min after treatment. Hence, the positive control substance is considered as ocular corrosive or severe irritant.
For negative control substance, the mean maximum opacity score after treatment is 1.0 (Class II); the mean fluorescein retention score at 30 min after treatment is 0.5 (Class I). Hence, the negative control substance is not considered as ocular corrosive or severe irritant.
Under the condition of the study strontium ferrite is not considered as ocular corrosive or severe irritant using Isolated Chicken Eye Test Method.
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