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Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study (OECD 437)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Version / remarks:
(September 07, 2009)
Deviations:
no
Principles of method if other than guideline:
Additionally, the study follows the testing strategy for determination of eye irritation/corrosion as given in the following OECD guideline: OECD Guideline for Testing of Chemicals No. 405, April 24, 2002 (“Acute Eye Irritation/Corrosion”).
GLP compliance:
yes (incl. QA statement)
Remarks:
(BASF SE, Experimental Toxicology and Ecology, Ludwigshafen, Germany)

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(2-hydroxyethoxy)-3-[4-(2-methyloctyl)phenoxy]propan-2-ol; 2-(2-hydroxyethoxy)-3-[4-(2-methyloctyl)phenoxy]propan-1-ol
EC Number:
807-586-4
Cas Number:
634602-80-5
Molecular formula:
Unspecified
IUPAC Name:
1-(2-hydroxyethoxy)-3-[4-(2-methyloctyl)phenoxy]propan-2-ol; 2-(2-hydroxyethoxy)-3-[4-(2-methyloctyl)phenoxy]propan-1-ol

Test animals / tissue source

Species:
other: bovine
Strain:
other: isolated bovine cornea, Schlachthof Bensheim, Bensheim, Germany

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: control cornea with: De-ionized water (negative control) or Sodium hydroxide 1% (w/v) solution in de-ionized water (positive control)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 μL of the undiluted liquid test substance or negative control and positive control, respectively
Duration of treatment / exposure:
approximately 10 min
Observation period (in vivo):
Additional to the exposure period:

Equilibration period: at least 1 h
Post-exposure period: 2 h
Number of animals or in vitro replicates:
Other:
Number of corneas used: Each treatment group (test substance, NC and PC) consisted of 3 corneas.
Details on study design:
The objective was to assess the potential of the test substance to cause serious damage to isolated bovine corneas for product safety and regulatory purposes. After application of the test material to the epithelial surface of the corneas, corneal opacity is measured quantitatively as the amount of light transmission through the cornea. Permeability is measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements are used to calculate an In Vitro Irritancy Score (IVIS) of the test substance, which is used for prediction of serious eye damage.
Before measurement, each cornea was observed visually and observations were recorded. Final corneal opacity readings were taken for each cornea with an opacitometer. For determination of permeability the medium in the anterior chamber was replaced by 1 mL sodium fluorescein solution (4 mg/mL for liquid test substances and surfactants) and incubated for 90 ± 5 min in a horizontal position at about 32°C. The amount of sodium fluorescein that permeated through the corneas into the posterior chamber was measured spectrophotometrically. Three aliquots per cornea were transferred to a 96-well microtiter plate and the optical density (OD490) was determined.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: IVIS
Basis:
mean
Remarks:
(3 corneas)
Score:
1.2
Remarks on result:
other: Negative control
Irritation parameter:
other: IVIS
Basis:
mean
Remarks:
(3 corneas)
Score:
1
Remarks on result:
other: Test group
Irritation parameter:
other: IVIS
Basis:
mean
Remarks:
(3 corneas)
Score:
166.4
Remarks on result:
other: Positive control
Irritation parameter:
other: Opacity score
Basis:
mean
Remarks:
(3 corneas)
Score:
1.2
Remarks on result:
other: Negative control
Irritation parameter:
other: Opacity score
Basis:
mean
Remarks:
(3 corneas)
Score:
1
Remarks on result:
other: Test group
Irritation parameter:
other: Opacity score
Basis:
mean
Remarks:
(3 corneas)
Score:
127.7
Remarks on result:
other: Positive control
Irritation parameter:
other: Permeability score
Basis:
mean
Remarks:
(3 corneas)
Score:
0
Remarks on result:
other: Negative control
Irritation parameter:
other: Permeability score
Basis:
mean
Remarks:
(3 corneas)
Score:
0.003
Remarks on result:
other: Test group
Irritation parameter:
other: Permeability score
Basis:
mean
Remarks:
(3 corneas)
Score:
2.581
Remarks on result:
other: Positive control

Applicant's summary and conclusion

Interpretation of results:
other: no severe eye damage