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Toxicological information

Eye irritation

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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:
secondary source
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