Registration Dossier

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:
1992-07-27 - 1992-10-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute 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
- Source: Dr. K. Thomae GmbH, Biberach/Riss, Germany
- Weight at study initiation: 2460 - 2590 g
- Housing: Individually in metal cages
- Diet: Standard diet, ad libitum
- Water: Fresh water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 30 - 70 %
- Photoperiod: 12 hours light cycle day

IN-LIFE DATES: From: 1992-08-04/1992-09-08 To: 1992-08-07/1992-09-11

Test system

Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL (24 mg) test substance/animal
Duration of treatment / exposure:
> 24 h
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
3 (female rabbits)
Details on study design:
TREATMENT
- On test day 1, 24 mg of the test item was placed into the conjunctival sac of the left eye of each animal, after gently pulling the lower lid away from the eyeball. The lids were then held together for about one second to prevent loss of the test item. The right eye remained untreated and served as a control.

REMOVAL OF TEST ITEM
- Washing: no, eyes were not rinsed

SCORING SYSTEM:
- The eyes of each animal were examined 1, 24, 48 and 72 hours after administration. The irritant/corrosive potency of the test item was classified according to the numerical scoring system given in OECD TG 405.

TOOL USED TO ASSESS SCORE: slit-lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(3 animals)
Time point:
other: 1 hour
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(3 animals)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
(3 animals)
Time point:
other: 1 hour
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
iris score
Basis:
mean
Remarks:
(3 animals)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(3 animals)
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(3 animals)
Time point:
other: 24 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(3 animals)
Time point:
other: 48, 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(3 animals)
Time point:
other: 1 hour
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(3 animals)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
No corrosion of the cornea was observed at any of the measuring Intervals.

Any other information on results incl. tables

The body weight gain of all rabbits was comparable. No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

In a primary eye irritation study, 24 mg (0.1 mL) of the test item (as described in section 1.2) was instilled into the conjunctival sac of the left eye of three New Zealand White rabbits. Eyes were not rinsed after application. Animals were then observed for 3 days and the irritation was scored. Minimal conjunctival redness (score 1), minimal conjunctival swelling (score 1), and minimal iris reaction (score 1) was observed in some test animals at the one-hour reading, fully reversible within 24 hours (iris reaction, conjunctival swelling) and 48 hours (conjunctival redness). No further signs of eye irritation were noted throughout the test. In this study, the test item is not an eye irritant.