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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
The study was conducted on the 1 October 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 1= Reliable without restriction o GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015

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)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-{2-[(2-ethylhexyl)oxy]ethoxy}ethyl prop-2-enoate
Cas Number:
117646-83-0
Molecular formula:
C15H28O4
IUPAC Name:
2-{2-[(2-ethylhexyl)oxy]ethoxy}ethyl prop-2-enoate
Test material form:
other: liquid
Details on test material:
Identification: M120
Batch: NC-5635-01
Purity: Not supplied
Physical state/Appearance: Clear colorless liquid
Expiry Date: 05 December 2015
Storage Conditions: Room temperature in the dark

Results and discussion

Any other information on results incl. tables

Corneal Opacity and Permeability Measurement

Individual and mean corneal opacity measurements and individual and mean corneal permeability measurements are given in the table below:

Treatment Cornea Number Opacity  Permeability (OD)  In Vitro Irritancy Score
Pre-Treatment  Post-Treatment  Post Incubation Post-Incubation
- Pre-Treatment		 Corrected Value   Corrected Value
Negative Control 5 3 3 4 1   0.008    
18 3 3 5 2   0.010    
19 3 3 4 1   0.004    
        1.3*   0.007**   1.4
Positive Control 22 2 28 28 26 24.7 1.016 1.009  
23 2 25 27 25 23.7 0.973 0.966  
24 2 32 35 33 31.7 1.452 1.445  
          26.7***   1.14*** 43.8
Test Item 26 2 3 4 2 0.7 0.036 0.029  
27 3 2 3 0 0 0.009 0.002  
28 3 4 3 0 0 0.012 0.005  
          0.2***   0.012*** 0.4

OD = Optical density * = Mean of the post-incubation - pre-treatment values ** = Mean permeability *** = Mean corrected value

Corneal Epithelium Condition

The corneas treated with the test item were clear post treatment. The corneas treated with the negative control item were clear post treatment. The corneas treated with the positive control item were cloudy post treatment.

 

In Vitro Irritancy Score

TheIn Vitroirritancy scores are summarized as follows:

Treatment

In Vitro Irritancy Score

Test Item

0.4

Negative Control

1.4

Positive Control

43.8

 

 

Criteria for an Acceptable Test

The positive controlIn VitroIrritancy Score was within the range of 29.6 to 52.0. The positive control acceptance criterion was therefore satisfied.

The negative control gave opacity of ≤2.9 and permeability ≤0.103. The negative control acceptance criteria were therefore satisfied.

 

CONCLUSION

No category. Not requiring classification to UN GHS or EU CLP.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No category. Not requiring classification to UN GHS or EU CLP.