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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
between 07 December 2011 and 08 December 2011.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
Principles of method if other than guideline:
The purpose of this study was to determine the eye irritation potential of the test material using the SkinEthic Reconstituted Human Corneal model (HCE, SkinEthic Laboratories, Nice, France) after a treatment period of 10 and 60 minutes. The test is based on the hypothesis that irritant chemicals are able to penetrate the corneal epithelial tissue and are sufficiently cytotoxic to cause cell death.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1,6-bis({2,2-bis[(undecyloxy)methyl]butyl}) hexanedioate
EC Number:
700-772-5
Cas Number:
1190961-28-4
Molecular formula:
N/A - too complex
IUPAC Name:
1,6-bis({2,2-bis[(undecyloxy)methyl]butyl}) hexanedioate
Test material form:
other: liquid
Details on test material:
- Substance type: UVCB
- Physical state: clear extremely pale straw coloured viscous liquid
- Analytical purity:100% UVCB
- Lot/batch No.: 010154379
- Expiration date of the lot/batch: 06/17/2012
- Storage condition of test material: room temperature in the dark
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: 17 June 2012
- Date Recieved: 07 October 2011

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark
- Stability under storage conditions: Stable
- Stability under test conditions: Stable

Test animals / tissue source

Species:
human
Details on test animals or tissues and environmental conditions:
The SkinEthic RHC model consists of transformed human keratinocytes of the cell line HCE (LSU EYE Center, New Orleans, USA) that form a corneal epithelial tissue (mucosa), devoid of stratum corneum, resembling, histologically, the mucosa of the human eye.
On arrival, the SkinEthic HCE tissues (Day 6 cultures), were stored at room temperature prior to transferring into 6-well plates designated ‘arrival plates’ containing 1mll of maintenance medium. It was important to ensure that there were no air bubbles present under the tissue inserts. The tissues were incubated overnight at 37°C, 5% CO2 in air.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30ul
- Concentration (if solution): Undiluted


Duration of treatment / exposure:
10 min and 60 min
Observation period (in vivo):
All the tissues were rinsed after treatment, and each tissue was placed into a pre-labelled 24-well plate containing 300 μl of maintenance medium (at room temperature ) until all the tissues were rinsed.
Number of animals or in vitro replicates:
Duplicate tissues for negative control group;
Triplicate tissues for test material treated group;
Duplicate tissues for positive control group
Details on study design:
See information presented in the below section "Any other information on materials and methods incl. tables"

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
other: Relative mean tissue viability
Run / experiment:
10 minute exposure
Value:
102.9
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation parameter:
other: Relative mean tissue viability
Run / experiment:
60 minute exposure
Value:
93.2
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
The results of the assay are considered acceptable if the acceptance criterion for the positive control induced a mild-moderate irritant response relative to the negative control tissues.
However the positive control induced a response of <60% after a 10 minute exposure period that was classed as clearly irritant according to the prediction model. As this response indicates the tissues were sensitive to response and the test item was
clearly negative, the results were considered acceptable and the integrity of the study was not compromised.

Any other information on results incl. tables

Results

The test material was not able to directly reduce MTT.

The relative mean viability of the test material treated tissues after a 10 or 60 minute exposure was 102.9% and 93.2%, respectively

It was considered unnecessary to proceed with tissue histopathology.

Quality criteria

The quality criteria required for acceptance of results in the test were satisfied.

Conclusion

According to the protocol followed the test material was considered to be non-irritant.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the protocol followed the test material was considered to be non-iIrritant.
Executive summary:

Introduction.The purpose of this study was to determine the eye irritation potential of the test material using the SkinEthic Reconstituted Human Corneal model (HCE, SkinEthic Laboratories,,) after a treatment period of 10 or 60 minutes. The test is based on the hypothesis that irritant chemicals are able to penetrate the corneal epithelial tissue and are sufficiently cytotoxic to cause cell death.

Methods.The experimental design of the study consists of a test for direct reduction of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphen-tetrazoum bromide) by the test material followed by the main test.

For the main test, triplicate SkinEthic tissues were treated with 30 uI of the test material for 10 or 60 minutes. Duplicate tissues treated with 30 u1 of Solution A served as the negative control and duplicate tissues treated with 30 u1 of 0.5% w/v Sodium Dodecyl Sulphate served as the positive control.

At the end of the exposure period each SkinEthic tissue was rinsed. The rinsed tissues (two per group) were taken for MTT loading. The remaining tissues were retained for possible histopathology. Following MTT loading the reduced MTT was extracted from the tissues.

After extraction the absorbency of triplicate aliquots of the extracted MTT solution for each SkinEthic tissue was measured. The optical density was measured at 540 nm (OD5&)). Data are presented in the form of % viability (MTT conversion relative to negative controls).

The test material was classified according to the following criteria:

RelativeMeantissueviability

(%ofnegativecontrol)

 

Predictions

 

10minutes:       <60

 

Irritant

10minutes:       >60

60minutes:       <60

 

Mild-moderate irritant

10minutes:       >60

60minutes:       <90

Equivocalresult

furtherinvestigation e.g.histopathology maybeconsidered

10minutes:       >60

60minutes:       >90

 

Negativeresult,notlikelytobeasevereocularirritant

Results.The relative mean viability of the test material treated tissues after a 10 minute and 60 exposure was 102.7% and 92.3%, respectively. It was considered unnecessary to proceed with tissue histopathology.

Quality criteria.The quality criteria required for acceptance of results in the test were satisfied.

Conclusion.According to the protocol followed the test material was considered to be non - irritant.