Registration Dossier

Toxicological information

Eye irritation

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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:
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:
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:
2016
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
Name:
Unnamed
Type:
Constituent
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