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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:
1989-11-02 to 1989-12-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted February 24, 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: males 14 weeks, female 15 weeks
- Weight at study initiation: males 2.5-2.6 kg, female 2.4 kg
- Housing: individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing WE. Ehret GmbH, Versuchstiertechnik, D-7830 Emmendingen)
- Diet: ad libitum, pelleted Kliba 341, Batch 48/89 and 49/89 rabbit maintenance diet ("Kliba", Kingenmuehle AG, CH-4303 Kaiseraugst)
- Water: ad libitum, community tap water from Itingen
- Acclimation period: 4 days under laboratory conditions after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

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 g of the test substance was instilled into the conjunctival sac of the left eye
- Concentration: undiluted
Duration of treatment / exposure:
7 days, single exposure, no washing
Observation period (in vivo):
7 days, Reading points: 1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
The test article (0.1 g per animal) 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 the test article. The right eye remained untreated and served as the reference control.

REMOVAL OF TEST SUBSTANCE
- Washing : No

SCORING SYSTEM: According to OECD guideline 405 (Draize et al.)

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
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #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
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #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
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
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
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:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Corrosion: Corneal opacity was observed in one animal (no.71, female) from 1 to 72 hours after treatment. No opacity was observed in any other animal.
Other effects:
Clinical symptoms / Mortality: No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.
Coloration: No staining of the cornea and conjunctivae of the treated eyes by pigment or coloring of the test article was observed.
Body weights: The body weight gain of all rabbits was similar.
Necropsy: No necropsy was performed. All animals were killed and discarded.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

24 h

 0/0/1

 0/0/1

 2/2/2

 1/1/2

48 h

 0/0/1

 0/0/0

 2/2/2

 0/0/1

72 h

 0/0/1

 0/0/0

 1/1/1

 0/0/0

Average 24h, 48h, 72h

 0/0/1

 0/0/0.33

 1.67/1.67/1.67

 0.33/0.33/1

Reversibility*)

 c.

 c.

 c.

 c.

Average time for reversion

 72h

 72h

 7days

 72h

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the present study conducted according to OECD guideline 405 (adopted February 24, 1987) 0.5 g Compimide MDAB were instilled into the conjuctival sac of three New Zealand White rabbits (two male and one female animal). The treated eyes were not rinsed and the effects of the test item were recorded at 1h, 24h, 48h and 72h after application. After another 21 days observation period the animals were sacrificed and discarded. In all three animals a slight conjunctival redness was detected at the 72h reading (score 1) but the redness was fully reversible within 7 days, thus, the test item does not need to be classified according to Regulation (EC) No 1272/2008 (CLP) and the globally harmonized system of classification and labelling of chemicals (GHS).