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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Report contains tabulated results only. The study was conducted prior to introduction of GLP and current test guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The study was conducted prior to development of current guidelines. Reporting of the methodology is poor; the study does not appear to conform to current guidelines but generally follows the method of Draize - irritation was assessed following a single application, and following 7 daily applications.
GLP compliance:
no
Remarks:
Conducted prior to development of GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methyl-2-pent-2-enylcyclopent-2-enone
EC Number:
207-668-4
EC Name:
3-methyl-2-pent-2-enylcyclopent-2-enone
Cas Number:
488-10-8
Molecular formula:
C11H16O
IUPAC Name:
3-methyl-2-pent-2-enylcyclopent-2-enone
impurity 1
Chemical structure
Reference substance name:
(E)-3-methyl-2-(pent-2-enyl)cyclopent-2-en-1-one
EC Number:
228-410-7
EC Name:
(E)-3-methyl-2-(pent-2-enyl)cyclopent-2-en-1-one
Cas Number:
6261-18-3
Molecular formula:
C11H16O
IUPAC Name:
3-methyl-2-pent-2-en-1-ylcyclopent-2-en-1-one
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Rabbits were used, no further information is provided

Test system

Vehicle:
other: Neantime; diethyl benzene-1,2-dicarboxylate
Controls:
yes, concurrent vehicle
Amount / concentration applied:
Test concentrations for the single application were 100%, 30%, 10%, 3% and 1%
Test concentrations for the repeat applications were 10%, 3% and 1% (based on results obtained in the single application study).

The vehicle used was neantime.
Duration of treatment / exposure:
The irritation was assessed following a single application of the test substance initially and then proceeded to repeated application for 7 consecutive days.
Observation period (in vivo):
Observations were made for 7 days after the last application
Number of animals or in vitro replicates:
No information provided
Details on study design:
Irritation was scored according to the following system:
- = no reaction
(+) = slight redness
+ = moderate redness and secretion
++ = strong redness and strong secretion
+++ = strong redness and strong secretion and oedema

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
Based on the results provided on the irritation test on the rabbit eye, it is concluded that this substance does cause eye irritation at 3%.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
Based on the results provided on the irritation test on the rabbit eye, it is concluded that this substance does cause eye irritation at 100%.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
Based on the results provided on the irritation test on the rabbit eye, it is concluded that this substance does cause eye irritation at 100%.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Remarks:
not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Remarks:
not specified
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Remarks:
not specified
Irritant / corrosive response data:
Single application: no reactions were observed following treatment with the 1% concentration. Treatment with 3% caused slight redness 1 day after application that had completely resolved by day 2. Treatment with 30% caused moderate redness and secretion 1 day after application, which reduced to slight redness 2 days after application. Signs of irritation had resolved by Day 3. Treatment with the undiluted test substance caused strong redness, strong secretion and oedema 1 day after application; signs of irritation ameliorated from then on and eyes were completely free of irritation by Day 6.
Repeat applications: no reactions were observed following 7 days repeat exposure to the 1% concentration. 7 days repeat treatment with the 3% and 10% concentrations resulted in slight redness at each observation, which persisted to study termination on Day 7.
The vehicle (neantime) was reported to have a highest non-irritant concentration of 10% following single application, and 100% following repeat application.
Other effects:
No other effects reported.

Any other information on results incl. tables

A: Single application:

 

Substance

Lowest irritant concentration

Highest non-irritant concentration

Giv 1-0985

Ro 6-8198

3%

1%

Solvent

-

10%

 

Duration of the lesions:

Substance

Concentration %

Day 1

Day 2

Day 3

Day 4

Day 5

Day 6

Day 7

Giv 1-0985

Ro 6-8198

100

+++

++

+

(+)

(+)

-

-

30

+

(+)

-

-

-

-

-

10

(+)

-

-

-

-

-

-

3

(+)

-

-

-

-

-

-

1

-

-

-

-

-

-

-

Solvent

100

-

-

-

-

-

-

-

 

Evaluation:

- = No reaction

(+) = Slight redness

+ = Slight redness and secretion

++ = Moderate redness and strong secretion

+++ = Strong redness and strong secretion and oedema

 

B: Repeated application on 7 consecutive days-Score after last application:

Substance

Lowest irritant concentration

Highest non-irritant concentration

Giv 1-0985

Ro 6-8198

3%

1%

Solvent

-

10%

 

Substance

Concentration %

Day 1

Day 2

Day 3

Day 4

Day 5

Day 6

Day 7

Giv 1-0985

Ro 6-8198

100

Not done

 

 

 

 

 

 

30

Not done

 

 

 

 

 

 

10

(+)

(+)

(+)

(+)

(+)

(+)

(+)

3

(+)

(+)

(+)

(+)

(+)

(+)

(+)

1

-

-

-

-

-

-

-

Solvent

100

-

-

-

-

-

-

-

 

Evaluation:

- = No reaction

(+) = Slight redness

+ = Slight redness and secretion

++ = Moderate redness and strong secretion

+++ = Strong redness and strong secretion and oedema

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information at 3% concentration Criteria used for interpretation of results: EU
Conclusions:
Based on the results provided on the irritation test on the rabbit eye, it is concluded that this substance does cause eye irritation at 3%.
Executive summary:

The eye irritation potential of Jasmone was evaluated in rabbits. A single application was made to the rabbit eye at concentrations of 100%, 30%, 10%, 3% and 1% (in neantime). Signs of irritation were recorded daily for 7 days after application. In addition, concentrations of 10%, 3% and 1% were applied daily for 7 days and signs of irritation recorded daily for 7 days after the last application. A single application of 3, 10 or 30% test substance caused slight redness (erythema) which resolved by Day 2. No irritant reactions were observed following treatment with 1%. A single application of 100% test substance caused strong redness (erythema), secretion and oedema; symptoms reduced over the following days and eyes were free from irritation by Day 6. Repeated application with 1% test substance caused no adverse effects. Slight redness (erythema) was observed following 7 -days repeat application with 3% and 10% test substance; effects persisted to study termination (7 days after the last application). The vehicle (neantime) was reported to have a highest non-irritant concentration of 10% following single application, and 100% following repeat application.

It was concluded that the highest non-irritating concentration of the test substance was 1%, and the lowest irritant concentration was 3%.