Registration Dossier
Registration Dossier
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EC number: 943-154-2 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Eye irritation, Eye Irritection assay, H318: Causes serious eye damage
Skin irritation, Dermal Irritection assay, slight irritant. Overall assessment, not irritant
Key value for chemical safety assessment
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study following in-vitro guideline under validation
- Principles of method if other than guideline:
- Ocular Irritection Assay System (refinement of the former Eyetex method)The system evalutes the ocular hazard effects of test chemicals based on the premise that eye irritation and corneal opacity after exposure to rirritating substances is the result of perturbation or denaturation of corneal proteins. The test method maels use of a macromolecular reagent composed of a mixture of proteins and glycoproteins, carbohydrates, lipids and low molecular weight components, which when rehydrated, form an ordered molecular matrix mimicking the structure of the transparent cornea. Irritatn substances produce a turbidity of the reagent by changing both protein conformation and degree of hydration. Changes in the turbidity of the reagent solution caused by the tested material can be quantified by measuring an increase in the light scattering detected at a wavelenght of 405 nm with the help of a spectrometer. The increase in optical density produced by the test material is compared with that prodcued by a set of calibration substances eahc of which having rpeviously estimated in vivo irritancy potential.
- GLP compliance:
- no
- Details on test animals or tissues and environmental conditions:
- Reagent pH before activation: 8.19Reagent pH after activation: 5.98Reagent temperature: 25°CKit Lot Number: 110700
- Amount / concentration applied:
- 1, 5, 10 and 25%
- Duration of treatment / exposure:
- 5h
- Irritation parameter:
- other: opacity
- Remarks on result:
- other: results are reported in the relevant section
- Interpretation of results:
- irritating
- Remarks:
- Migrated informationunder Regulation 1272/2008
- Conclusions:
- The substance was tested for eye irritation potential by means of Ocular Irritection Assay. Under the experimental conditions the substance showed eye irritation properties.
- Executive summary:
The substance was tested for eye irritation potential by means of Ocular Irritection Assay. Doses of 1, 5, 10 and 25 % of the test item were applied to the matrix mimicking the ordered structure of the cornea for 5h. Irritection score were all in the mild range. Under the experimental conditions the substance showed an increase in turbidity and therefore eye irritation properties classified as H319 Category 2.
Reference
| Dose | irritation score | |
| 1 | 14.3 | |
| 5 | 14.9 | |
| 10 | 14.5 | |
| 25 | 14.5 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Additional information
In vitro Irritection tests are available for both eye and skin irritation properties (Ricci; 2002) on the substance and on a group of substances that differ from the target substance only for the lenght of the fatty acid in the final structure.
Eye irritation was determined by Ocular Irritection Assay on the substance (and similar substances) with a result as a mild/modearte eye irritant in the Draize score system.
Skin irritation was determined on a similar substance by Dermal Irritection Assay, which resulted as mild skin irritant. However, based on the considerations reported in the attached document and on the read across considerations no skin irritation potential is considered for the substance while eye irritation potential is classified as H318.
Effect level: empty Endpoint conclusion: Adverse
effect observed
Justification for classification or non-classification
The irritative scores determined by the Irritection Assay (dermal and Ocular) classify the substance as H318 and do not classify the substance for skin irritation under Regulation 1272/2008 ( refer to the attached document).
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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