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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
4 June 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, to GLP

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methyl-5-propylcyclohex-2-enone
EC Number:
223-069-0
EC Name:
3-methyl-5-propylcyclohex-2-enone
Cas Number:
3720-16-9
Molecular formula:
C10H16O
IUPAC Name:
3-methyl-5-propylcyclohex-2-en-1-one
Constituent 2
Reference substance name:
3-methyl-5-propylcyclohexen-2-one
IUPAC Name:
3-methyl-5-propylcyclohexen-2-one
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): 3-Methyl-5-propylcyclohexen-2-one
- Substance type: No data
- Physical state: colourless to slightly yellow liquid
- Analytical purity: 99.9%
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: 3-Methyl-5-propylcyclohexen-2-one (99.9%)
- Isomers composition: No data
- Purity test date: 6 March 2014
- Lot/batch No.: SC00005427
- Expiration date of the lot/batch: 16 December 2014
- Stability under test conditions: No data
- Storage condition of test material: room temperature in the dark

Test animals / tissue source

Species:
other: chicken eye
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Etablissement Brun, 33820 Etauliers, France
- Age at study initiation: 7 weeks
- Weight at study initiation: 1.5-2.5 kg
- Housing: Not applicable
- Diet (e.g. ad libitum): Not applicable
- Water (e.g. ad libitum): Not applicable
- Acclimation period: Eyes were incubated between 54 and 67 minutes to equilibrate them to the test system prior to dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 31.9-33
- Humidity (%): Not applicable
- Air changes (per hr): Not applicable
- Photoperiod (hrs dark / hrs light): Not applicable

IN-LIFE DATES: From: 4 June 2014 To: 4 June 2014

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: one negative and three postive controls
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 μL
- Concentration (if solution): Not applicable

VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable
Duration of treatment / exposure:
10 seconds
Observation period (in vivo):
4 hours
Number of animals or in vitro replicates:
3 enucleated chicken eyes
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with 20 mL of physiological saline
- Time after start of exposure: 10 seconds

SCORING SYSTEM: ICE classes were assigned based on a pre-determined range (see table) as specified in the guideline

TOOL USED TO ASSESS SCORE: corneal swelling was assessed using a slit-lamp microscope

OTHER:
Negative control: physiological saline
Positive control: 5% Benzalkonium chloride (0.5 g in 10 mL physiological saline)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: maximal mean corneal opacity score
Basis:
mean
Time point:
other: 120-240 minutes
Score:
3
Max. score:
4
Irritation parameter:
other: fluorescein retention
Basis:
mean
Time point:
other: 30 minutes
Score:
0.5
Max. score:
3
Irritation parameter:
other: maximal cornea swelling
Basis:
mean
Time point:
other: 75 minutes
Score:
18
Max. score:
100
Irritant / corrosive response data:
No data
Other effects:
No data

Any other information on results incl. tables

    Endpoint measured  Eye Number     Time/min               
 0  30  75  120  180  240
Corneal opacity        9  0  1  2  3  3  3
10  0  1  2  3  3  3
11  0  1  2  3  3  3
Mean      0.0  1.0  2.0  3.0  3.0  3.0
ICE Class                    IV
Fluorescein retention 9  0  0.5        
10  0.5  0.5        
11  0.5  0.5        
    Mean  0.3  0.5        
    ICE Class                  I
Corneal swelling        9  -  11  14  13  11  14
10  -  2  16  18  16  16
11  -   15  25  16  18  16
Mean      -  9  18  16  15  15
ICE Class                     III
Classification                     Non "corrosive/severe irritant"

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a guideline study (OECD TG 438), to GLP, celery ketone was not corrosive/severe irritant to the eye according EU labelling regulations.
Executive summary:

In an OECD guideline study (TG 438), conducted according to GLP, celery ketone was not a corrosive/severe irritant to the chicken eye. In accordance with EU regulations, the test item does not require the classification Category 1 (irreversible effects on the eyes).