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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 September 2011 - 21 November 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: OECD Guideline 438 (Isolated Chicken Eye Test), 7 September 2009
Deviations:
no
Qualifier:
according to
Guideline:
other: EU method B.48 (Identification of chemicals inducing serious eye damage), 8 December 2010
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
(Date of inspection: 4-8 October 2010)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ammonium Perrhenate

- Substance type: White crystal powder

- Physical state: Solid

- Analytical purity: > 99.9%

- Lot/batch No.: 11411

- Expiration date of the lot/batch: 19 April 2012

- Stability under test conditions: Not tested.

- Storage condition of test material: Room Temperature (15-30ºC, 40-70%, in a dark storeroom without windows)

Test animals / tissue source

Species:
other: Male and female chickens (eyes)
Strain:
other: COBB 500
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: TARAVIS KFT. 9600 Sárvár, Rábasömjéni út. 129.

- Age at study initiation: (eyes from 6 weeks old male and female chickens). See details of chicken heads collection, treatment and eye selection in 'Any other information on materials and methods incl. tables'.

- Acclimation period: 45 to 60 minutes. See details in 'Any other information on materials and methods incl. tables'.

- Others: Slight changes in thickness (-3% to 1%) were observed in the eyes in comparison to a base line. This is considered normal when maintaining enucleated eyes following the equilibration period. The fluorescein retention was measured. Base line values were required to evaluate any potential test item related effects after treatment; the location of any minor findings were marked on the record sheet as a drawing. All eyes were considered to be suitable for the assay.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 32 ± 1.5°C

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Positive control: Eyes treated with 30 mg imidazole. Negative control: Eyes treated with 30 µL of isotonic saline.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 30 mg, applied as supplied, to the entire surface of the cornea attempting to cover the cornea surface uniformly with the test substance.
Duration of treatment / exposure:
10 seconds
Observation period (in vivo):
Pre-treatment and at approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse.
Number of animals or in vitro replicates:
3 eyes for the test substance; 3 eyes for the positive control; one eye for the negative control.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: With approximately 20 ml of isotonic saline.

- Time after start of exposure: 10 seconds.

SCORING SYSTEM: The cornea thickness and cornea opacity were measured at all time points. The classification criteria were in accordance with the OECD test guideline 438.

TOOL USED TO ASSESS SCORE: Fluorescein retention (as a qualitative assessment of damage to the epithelium) was measured on two occasions, at base line (t=0) and 30 minutes after the post-treatment rinse.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Maximum corneal swelling
Basis:
mean
Time point:
other: Up to 75 min
Score:
0.33
Max. score:
32
Reversibility:
fully reversible within: 240 min
Remarks on result:
other: Unit %. Max corneal swelling of 1% seen in 1 eye out of 3
Irritation parameter:
other: Maximum corneal opacity
Basis:
mean
Time point:
other: 240 min
Score:
0
Max. score:
4
Reversibility:
other: No effects seen at any time point
Remarks on result:
other: Qualitative assessment
Irritation parameter:
other: Fluorescein retention
Basis:
mean
Time point:
other: 30 min
Score:
0.33
Max. score:
3
Reversibility:
other: assessed only at 30 min
Remarks on result:
other: Max score of 0.5 at 30 min in 2 eyes out of 3. Qualitative assessment.
Irritant / corrosive response data:
The results of corneal thickness change, corneal opacity and fluorescein retention suggest that the test item was not irritating. The test item was not a severe irritant. See ICE class in the table in 'any other information on results incl. tables'.
Other effects:
There were no morphological effects with the treatment of test substance.

Any other information on results incl. tables

Positive control: The Test item was stuck on the cornea surface after the post-treatment rinse. The cornea surface was not cleared 240 min after the post-treatment rinse.

The negative control and positive control results were in line with historical data. This experiment was considered to be valid.

Table Mean values of the treated eyes and ICE class*

Observation

Value

ICE Class*

Mean maximum corneal swelling at up to 75 min

0.33 %

I

Mean maximum corneal swelling at up to 240 min

0.00 %

I

Mean maximum corneal opacity

0.00

I

Mean fluorescein retention

0.33

I

Other Observations

None

Overall ICE Class*

3 x I

* See OECD TG 438.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information not a severe irritant/corrosive Criteria used for interpretation of results: EU
Conclusions:
In this in vitro eye irritation study in the Isolated Chicken Eyes model with Ammonium Perrhenate, the results suggests that the test item was not a severe irritant/corrosive.
Executive summary:

An in vitro eye irritation study of the test item Ammonium Perrhenate was performed in isolated chicken’s eyes. The irritation effects of the test item were evaluated according to the OECD No.: 438 (07thSeptember 2009).

After the zero reference measurements, the eye was held in horizontal position and 30 mg of Ammonium Perrhenate was applied onto the centre of the cornea such that the entire surface of the cornea was covered. After 10 seconds, the surface was rinsed with saline. The positive control eyes were treated in a similar way with 30 mg Imidazole. The negative control eye was treated with 30 µL of isotonic saline. 

In this in vitro eye irritation study in the Isolated Chicken Eyes model with Ammonium Perrhenate, the results suggest that the test item was not severly irritating/corrosive. According to the guideline OECD 438,Ammonium Perrhenate does not require a classification as a severe eye irritant; an in vivo rabbit study is required to determine classification for mild/moderate irritation or non-irritant.