Registration Dossier
Registration Dossier
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EC number: 606-191-2 | CAS number: 18979-61-8
Eye irritation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 437 : Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants (September 2009)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: INVITTOX (UK) protocol no. 98 'The Bovine Corneal Opacity and Permeability Assay', dated February 1994
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Bovine Corneal Opacity and Permeability (BCOP) Assay, SOP of Microbiological Associates Ltd., UK, Procedure Details, April 1997
- Deviations:
- no
Test material
Constituent 1
Test animals / tissue source
- Species:
- other: In-vitro assessment using fresh bovine corneae
- Strain:
- other: In-vitro assessment using fresh bovine corneae
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: In-vitro irritation score
- Basis:
- other: Test item cornea #1
- Time point:
- other: 240 minutes
- Score:
- 434.1
- Irritation parameter:
- other: In-vitro irritation score
- Basis:
- other: Test item cornea #2
- Time point:
- other: 240 minutes
- Score:
- 431.1
- Irritation parameter:
- other: In-vitro irritation score
- Basis:
- other: Test item cornea #3
- Time point:
- other: 240 minutes
- Score:
- 431.1
Any other information on results incl. tables
Evaluation of Results
Opacity
The change of opacity value of each treated cornea or positive and negative control corneae was calculated by subtracting the initial basal opacity from the post treatment opacity reading (t240 - t0), for each individual cornea.
Permeability
The corrected OD 490 value of each cornea treated with positive control and test item was calculated by subtracting the average negative control cornea value from the original permeability value for each cornea.
In-Vitro Score Calculation
The following formula was used to determine the in-vitro score of the negative control :
In-vitro Score = opacity value + (15 X OD490 value)
The following formula was used to determine the in vitro score of the positive control and the test item :
In-vitro Score = (opacity value - opacity value mean negative control) + (15 x corrected OD490 value)
The in-vitro score was calculated for each individual treatment and positive control cornea. The mean in-vitro score value of each treated group was calculated from the individual in-vitro score values.
Depending on the score obtained, the test item was classified into one of the following categories :
| In-vitro Score | Proposed in-vitro irritation scale |
| 0 -3 | Non eye irritant |
| 3.1 -25 | Mild eye irritant |
| 25.1 - 55 | Moderate eye irritant |
| 55.1 - 80 | Severe eye irritant |
| > 80 | Very severe eye irritant |
Historical Data
| Positive control | Negative control | |
| Mean in-vitro score | 137.19 | 2.22 |
| Standard deviation | 34.87 | 0.47 |
values of 36 studies with solid test items performed in 2008 and 2009.
Results
Results after 240 minutes incubation time
| Test Group | Opacity value = Difference (t240 -t0) of Opacity | Permeability at 490 nm (OD490nm) | In-vitro Score | Mean in-vitro score | Proposed in-vitroIrritation Score |
| Negative control | 0 | 0.066 | 0.99 | ||
| Negative control | -1 | 0.052 | -0.22 | 0.50 | Non eye irritant |
| Negative control | 0 | 0.049 | 0.74 | ||
| Positive control | 126.33* | 0.212* | 129.52 | ||
| Positive control | 113.33* | 0.273* | 117.43 | 120.39 | Very severe eye irritant |
| Positive control | 111.33* | 0.192* | 114.22 | ||
| 4 -N-butyl resorcinol | 434.33* | -0.013* | 434.14 | ||
| 4 -N-butyl resorcinol | 431.33* | -0.010* | 431.19 | 432.15 | Very severe eye irritant |
| 4 -N-butyl resorcinol | 431.33* | -0.014 | 431.13 |
* : corrected values
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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