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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1963
Report date:
1963
Reference Type:
secondary source
Title:
Fragrance material review on alpha-iso-methylionone
Author:
Lapczynski A et al.
Year:
2007
Bibliographic source:
Food and Chemical Toxicology 45 (2007) S280–S289
Reference Type:
publication
Title:
A toxicologic and dermatologic assessment of ionones when used as fragrance ingredients
Author:
Belsito D et al.
Year:
2007
Bibliographic source:
Food and Chemical Toxicology 45 (2007) S130–S167

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Test material (0.1 ml) was instilled into the right eye of 3 albino rabbits with no further treatment. The untreated left eye served as a control. Both eyes were examined every 24 hours for 4 days and on day 7. Scoring was according to the Draize scale for ocular lesions.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one
EC Number:
204-846-3
EC Name:
3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one
Cas Number:
127-51-5
Molecular formula:
C14H22O
IUPAC Name:
3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one

Test animals / tissue source

Species:
rabbit
Strain:
other: stated as "albino"

Test system

Vehicle:
not specified
Controls:
other: left eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 12.5 %
Duration of treatment / exposure:
single application, substance remains in eye
Observation period (in vivo):
Both eyes were examined every 24 hours for 4 days and on day 7.
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: acc. Draize scale for ocular lesions

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
>= 2
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
> 1
Max. score:
4
Reversibility:
fully reversible within: 7 d

Any other information on results incl. tables

12.5 %: irritant effects

- intense conjunctival irritation from days 1 to 4 involving chemosis and discharge that cleared by day 7

- no corneal opacity or iris congestion

Applicant's summary and conclusion