Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
14 November 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
4,7-dimethyloct-6-en-3-one
EC Number:
219-845-3
EC Name:
4,7-dimethyloct-6-en-3-one
Cas Number:
2550-11-0
Molecular formula:
C10H18O
IUPAC Name:
4,7-dimethyloct-6-en-3-one
Test material form:
liquid
Specific details on test material used for the study:
Name: Dimethyl octenone
Batch No.: VE00428302
Appearance: colourless to pale yellow, liquid
Purity: 97.8%

Test animals / tissue source

Species:
cattle
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Fresh bovine eyes were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hanks' balanced salt solution (HBSS), (supplemented with 0.01% streptomycin and 0.01% penicillin). Then, the corneas were dissected and incubated in medium at 32 ± 1 °C in an incubation chamber for 1 h.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
11.01
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD492 value)

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
Under the conditions of this study, the test item Dimethyl Octenone showed effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 11.01.
Executive summary:

Under the conditions of this test, the test item Dimethyl Octenone showed effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 11.01.

The negative control (HBSS-solution) and the positive control (undiluted dimethylformamide) met the validity criteria.

No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.