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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 September 1996 - 14 October 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
423-860-2
EC Name:
-
Cas Number:
56309-94-5
Molecular formula:
Hill formula: C14H22O3 CAS formula: C14H22O3
IUPAC Name:
4-{1,4-dioxaspiro[4.5]decan-8-yl}cyclohexan-1-one

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
Crl: KBL (NZW) BR
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, Kißlegg
- Age at study initiation: approx. 25 weeks
- Weight at study initiation: 3.81 - 3.99 kg
- Housing: not specified
- Diet: Altromin Standard Diet TPF ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 20°C
- Humidity (%): 40 - 66%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount appied: 100 mg
Duration of treatment / exposure:
single application, rinsing of eyes of not performed
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize score
TOOL USED TO ASSESS SCORE: not specified

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
After installation conjunctival redness (score 1, all animals) and chemosis (score 2, 2/3 animals) was observed, being fully reversible within 24 hours.
Other effects:
2 animals showed outflow. This effect disappeared within 24 h reversibly.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the test item was not considered to be an eye irritant.
Executive summary:

An in vivo eye irritation test according to OECD 405 was performed to to evaluate the eye hazard potential of the test item.

No mortality and signs of systemic toxicity were observed. The body weight development was found to be in the normal range of this rabbit strain.

After single installation of 0.1 g test item into the conjunctival sac of the left eye, no signs of irritation to the cornea and iris were observed. The conjunctivae showed redness (score 1) in all rabbits at the first reading. Chemosis (score 2) was seen in two animals at the first reading. All findings were found to be fully reversible within 24 hours after test item installation. The untreated eyes were normal.

The cumulative mean scores per animal for cornea, iris and conjunctivae were 0 for the readings at 24 - 72 hours.

The test item did not show any eye irritating potential.