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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
18 April 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
1-cyclohexyl-1H-pyrrole-2,5-dione
EC Number:
216-630-6
EC Name:
1-cyclohexyl-1H-pyrrole-2,5-dione
Cas Number:
1631-25-0
Molecular formula:
C10H13NO2
IUPAC Name:
1-cyclohexyl-2,5-dihydro-1H-pyrrole-2,5-dione
Test material form:
solid: flakes

Test animals / tissue source

Species:
rabbit
Strain:
other: house
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Medical Experimental Animals Institute
- Age at study initiation:
- Weight at study initiation: between 2.0 and 2.5 kg
- Housing: stainless steel cage
- Diet (e.g. ad libitum): Oriental RC-4 solid feed
- Water (e.g. ad libitum): yes
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 50 ± 10%.
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): artificial lighting for 8 hours a day

IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1g
Duration of treatment / exposure:
30s
Observation period (in vivo):
1, 24, 48, and 72 hours after instillation
Number of animals or in vitro replicates:
6 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 30s

SCORING SYSTEM: draize

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 30 - <= 40
Max. score:
40
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 30 - <= 40
Max. score:
40
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 30 - <= 40
Max. score:
40
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
60
Max. score:
60
Reversibility:
other: Examination impossible due to severe chemosis.
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
60
Max. score:
60
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Remarks on result:
other: Examination impossible due to severe chemosis.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
5
Max. score:
5
Reversibility:
fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
5
Max. score:
5
Reversibility:
not fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
5
Max. score:
5
Reversibility:
fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
5
Max. score:
81
Reversibility:
other: Examination impossible due to severe chemosis.
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
5
Max. score:
5
Reversibility:
fully reversible within: 7 daya
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Reversibility:
other: Examination impossible due to severe chemosis.
Remarks on result:
not determinable
Remarks:
Examination impossible due to severe chemosis.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 3 - <= 4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The results of this study indicate that the effects on the eyes are not fully reversible in 21 days therefore it has been classified a Eye irritation Cat.2.