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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
October 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to guideline. In compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 438 (Isolated Chicken Eye 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:
Diethyldimethylcyclohex-2-en-1-one
EC Number:
272-462-3
EC Name:
Diethyldimethylcyclohex-2-en-1-one
Cas Number:
68845-36-3
Molecular formula:
C12H20O
IUPAC Name:
2,3-diethyl-4,4-dimethylcyclohex-2-en-1-one
Constituent 2
Reference substance name:
Azarbre
IUPAC Name:
Azarbre
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
Please note that although the substance is stated as the mono-constituent substance diethyldimethylcyclohex-2-en-1-one in the report, analytical data on the same batch shows that the test substance is in fact the multi-constituent substance Reaction mass of 3,5-diethyl-2,5-dimethyl-cyclohex-2-en-1-one and 3,5-diethyl-5,6-dimethylcyclohex-2-en-1-one .

Test animals / tissue source

Species:
other: Chicken
Strain:
not specified
Details on test animals or tissues and environmental conditions:
The eyes used in this assay were collected from c hickens obtained from a slaughterhouse (Etablissement Brun, 338 Etauliers, France) where they were killed for human consumption. Chicken age was generally 7 weeks old.
The eyes of the chickens were enucleated at Phycher.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
30uL of test item was applied
Duration of treatment / exposure:
The test item was applied for 10 seconds so that it covered the entire surface of the cornea evenly. It was then rinsed from the eye with 20mL of physiological saline at ambient templerature.
Observation period (in vivo):
Treated corneas were evaluated pretreatment and after treatment 30, 75, 120, 180 and 240 minutes (+/- 5 minutes).
Number of animals or in vitro replicates:
3 enucleated chicken eyes
Details on study design:
Negative controls (physiological saline) and positive controls (5% Benzalkonium chloride) were included in this experiment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Remarks:
Corneal Opacity
Basis:
mean
Score:
ca. 1.3
Remarks on result:
other: Corresponds to ICE class II
Irritation parameter:
other: Mean score of fluorescein retention
Basis:
mean
Score:
ca. 0.7
Remarks on result:
other: Corresponds to ICE class II
Irritation parameter:
cornea opacity score
Remarks:
Maximal mean corneal swelling
Basis:
mean
Time point:
other: 240 minutes post-dose
Score:
ca. 12
Remarks on result:
other: Corresponds to ICE class II

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The results obtained under the experimental conditions described, lead to the conclusion that Azarbre is not a corrosive / severe irritant.