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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclopropyl methyl ketone
EC Number:
212-146-4
EC Name:
Cyclopropyl methyl ketone
Cas Number:
765-43-5
Molecular formula:
C5H8O
IUPAC Name:
1-cyclopropylethan-1-one
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: small white russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult male animals
- Weight at study initiation: 2.1-2.5 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 01.12.1997 To: 19.12.1997

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: undiluted
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours, 6, 8, 10, 13 and 17 days after administration
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: rinsed with warm physiological saline
- Time after start of exposure: 24 hours

TOOL USED TO ASSESS SCORE: ophthalmic lamp / fluorescein (at the 24, 48 and 72 hours and after 6 and 8 days observation interval)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 17 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 17 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 13 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 17 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 17 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
24 to 72 hours and 6 days after the administration of the test substance, the animals showed reactions on the conjunctivae like diffuse, crimson
redness (individual vessels not easily discernible) to diffuse beefy red mucous membranes, little swelling above normal (including nictating
membranes) and nictating membranes with haemorrhages. After 24 hours scattered or diffuse areas of opacity were observed. 72 hours post
applicationem (p.a.) easily discernible translucent areas (details of iris slightly obscured) were observed. One animal showed partially moderate
hyperaemia of the iris after 24 and 48 hours. Discharge appeared in all animals 24 and 48 hours p.a.. 13 to 17 days after administration of the test substance all irritations of eye and mucous membrane had disappeared.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Remarks:
Migrated information
Conclusions:
In this eye irritation study in the rabbit the test item was irritating to the eye.