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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:
September 7, 2005 - September 16, 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
April 24, 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
April 29, 2004
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
(d.d. march 2003)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
457-080-9
EC Name:
-
Cas Number:
32940-15-1
Molecular formula:
C11H12O2
IUPAC Name:
5-Methoxy-3,4-dihydro-1H-naphthalen-2-one
Test material form:
solid: compact
Details on test material:
- Description: White-yellowish solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: Charles River Deutschland GmbH, Stolzenseeweg 32-36, D-88353 Kisslegg, Germany
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2763 g (male); 2252-2369 g (female)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 34/05) provided by Provimi Kliba AG, CH-4303 Kaiseraugst.
- Water: Community tap water from Füllinsdorf, ad libitum
- Acclimation: Yes (5 days one female; 6 days one male and one female)

ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 17 – 23
- Humidity (%): 30 - 70
- Air changes (per hr): approx 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: One eye of each animal remained untreated and served as the reference control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Duration of treatment / exposure:
Single instillation on Day 1.
Observation period (in vivo):
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance
Number of animals or in vitro replicates:
3
Details on study design:
TREATMENT
On the day of treatment, 0.1 g of the test substance was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation.
As it was suspected that the test item might produce irritancy, a single animal was treated first. As neither a corrosive effect nor a severe irritant effect was observed after the 1- and 24-hour examinations, the test was completed using the two remaining animals.

OBSERVATIONS
- Mortality/Viability: Daily
- Toxicity: Daily
- Body Weight: At start of acclimatization, on the day of application and at termination of observation
- Necropsy: No necropsy was performed
- Irritation: The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance.
The irritation scores and a description of other (local) effects were recorded. The irritation was assessed according to EU Method B.5 (2004).
Eye examinations were made with a Varta Cliptrix diagnostic-lamp.

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:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
- Slight reddening of the conjunctivae was noted in all animals from the 1- to the 24-hour reading and persisted in one animal until the 48-hour examination.
- Slight swelling (chemosis) of the conjunctivae was observed in two animals at the 1-hour reading and persisted in one animal until the 24-hour examination.
- Slight reddening of the sclerae was present in all animals at the 1-hour reading.
- Slight ocular discharge was seen in all animals at the 1-hour reading.
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.

Any other information on results incl. tables

- No corrosion was observed at any of the measuring intervals.

- No staining of the treated eyes by the test item was observed.

Applicant's summary and conclusion

Interpretation of results:
other: the substance does not need to be classified for eye irritation/corrosion according to GHS and CLP
Conclusions:
Based on the results of an eye irritation study with rabbits, performed according to OECD/EC test guidelines, it is concluded that the substance does not need to be classified for Eye irritation/corrosion in accordance with the CLP Regulation.
Executive summary:

The eye irritation potential of the substance was investigated according to OECD 405. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation. Slight reddening of the conjunctivae was noted in all animals from the 1- to the 24-hour reading and persisted in one animal until the 48-hour examination. Slight swelling (chemosis) of the conjunctivae was observed in two animals at the 1-hour reading and persisted in one animal until the 24-hour examination. The effects were reversible and were no longer evident 72 hours after treatment, the end of the observation period for all animals. No corrosion was observed at any of the measuring intervals. No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. Based on the results of this study it is concluded that the substance does not need to be classified for Eye irritation/corrosion in accordance with the CLP Regulation.