Registration Dossier
Registration Dossier
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EC number: 615-244-9 | CAS number: 71035-05-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Justification for type of information:
- Read across approach adequate to support 7.6.1 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017)
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Read across approach adequate to support 7.6.1 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017) - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Estimation of eye hazard within a range-finding test
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No data
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0,5 mL undiluted diethylene glycol
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- No data
- Details on study design:
- The individual numerical scores of each eye treated were added together and then divided by the number of treated eyes (usually 5 animals) to obtain the score of the injury caused by the treatment. The level of 5.0 was selected by the authors of the study as representative of severe injury.
When a test is to be performed, normal albino rabbits are selected on the basis of absence of grossly visible staining of the eye by a 5% aqueous solution of fluorescein sodium, flushed with distilled water 20 seconds after application. After a two-hour interval to allow the eye to return normal, the undiluted material is applied to the centre of the cornea while the lids are retracted. Eighteen to 24 hours later, the eye is examined in strong diffuse daylight, and then stained with fluorescein, and the injury scored. Guided by the result and the table of injury grades, additional applications are made until the chemical can be assigned to one of the grades they recognize. - Remarks on result:
- other: not available data
- Irritation parameter:
- other:
- Remarks:
- ocular irritation
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 10
- Reversibility:
- not specified
- Remarks on result:
- other: Grade 1
- Irritant / corrosive response data:
- No occular irritation was noticed after application of 0.5 mL of undiluted test item.
- Conclusions:
- GHS criteria for classification not met
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxtree - Toxic Hazard Estimation by decision tree approach
- Author:
- Ideaconsult Ltd
- Year:
- 2 016
- Bibliographic source:
- http://toxtree.sourceforge.net/
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Assessment of the eye irritating properties of chemicals by applying alternatives to the Draize rabbit eye test: the use of QSARs and in vitro tests for the classification of eye irritation.
Gerner I1, Liebsch M, Spielmann H. Altern Lab Anim. 2005 Jun;33(3):215-37.
Test material
- Reference substance name:
- Reference substance 002
- Cas Number:
- 10043-35-3
Constituent 1
- Specific details on test material used for the study:
- smile notation used B(O)(O)O
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Qsar
- Remarks on result:
- other: not estimated to be irritant
In vivo
Results
- Remarks on result:
- other: not available data
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
