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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 May to 24 May 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterized

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: EEC-Directive 84-449, Annex V, part B5
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3,20-bis(ethylenedioxy)pregna-5,7-diene
EC Number:
243-175-0
EC Name:
3,20-bis(ethylenedioxy)pregna-5,7-diene
Cas Number:
19592-55-3
Molecular formula:
C25H36O4
IUPAC Name:
(1S,3aR,9aR,9bS,11aS)-9a,11a-dimethyl-1-(2-methyl-1,3-dioxolan-2-yl)-1,2,3,3a,6,8,9,9a,9b,10,11,11a-dodecahydrospiro[cyclopenta[a]phenanthrene-7,2'-[1,3]dioxolane]
Test material form:
other: crystalline powder
Details on test material:
Off-white crystalline powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Itta Credo-Broekman B.V., Someren
- Weight at study initiation: 2.5 - 3.0 kg
- Housing: Three rabbits individually housed in stainless steel wire cages KK 102. Sawdust, woodchips, or other extraneous material that might produce eye irritation were excluded.
- Diet (e.g. ad libitum): 80 g food (a standard laboratory diet LKK-20, Hope Farms, Woerden, The Netherlands) per day during the acclimatization period.
- Acclimation period: 13 or 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 50-78%;
- Air changes (per hr): About 16

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other: right eye of each animal was untreated
Amount / concentration applied:
0.1 g of proketal
Duration of treatment / exposure:
A quantity of 0.1 g of proketal was placed in the conjunctiva! sac of the left eye by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was placed. The lids were then gently held together for one second and the rabbit was released. The other eye, remaining untreated, served as a control. At 24 hours after treatment, the exposed eye of one rabbit was treated with 2% sodium fluorescein in order to detect any corneal damage.
Observation period (in vivo):
Readings of reactions were made in all three rabbits at 1 and 24 hours after treatment and in two animals at 48 and 72 hours after treatment. Scoring of the irritation was performed according to the grades.
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
Before treatment both eyes were checked for sign of ocular irritation or defect with the aid of a direct light source. Only animals free of ocular damage were used in the study.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1-24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Animal was terminated after 24 h due to paralysis of hind legs
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1-24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Animal was terminated after 24 h due to paralysis of hind legs
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1-24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Animal was terminated after 24 h due to paralysis of hind legs
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1-24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Animal was terminated after 24 h due to paralysis of hind legs
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 h
Other effects:
One rabbit (animal number 2) was killed after examination at 24 hours, because of paralysed hind leg.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the standards described in EEC-Directive 83-467, proketal is not considered irritating or corrosive to the eye and does not need a symbol or a risk phrase with respect to eye irritation.