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:
From Sep. 14, 1981 to Sep. 21, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
-comparable to OECD 405, at the last time point of 7 days, one animal still had a redness of conjunctivae score of 1 (observation period should be up to 21 days)
GLP compliance:
no

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: Bred and raised rabbits on the premises (Ciba-Geigy Ltd. - Exp. Toxicology Sisseln GU 2.1)
- Age at study initiation: Not reported
- Weight at study initiation: 2 to 3 kg
- Housing: Housed individually in metal cages
- Diet (e.g. ad libitum): ad libitum, standard rabbit food
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 mL of physiological saline.
- Time after start of exposure: Approximately 30 seconds after treatment in 3 of the 6 rabbits

SCORING SYSTEM: Same scale as the one provided in the OECD guideline, with the exception of 1 criteria (changes related to discharge were included in addition to the other parameters evaluated)

TOOL USED TO ASSESS SCORE: slit lamp

The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4, and 7 and was scored for each individual rabbit. The mean reaction scores for cornea, iris and conjunctiva observed after 1, 2, 3, 4, and 7 days were summed up and the sum divided by 5. This procedure was carried out separately for unrinsed and rinsed eyes.

Index:
0 = none
0.1 - 10.9 = minimal
11.0 - 25.9 = slight
26.0 - 55.9 = moderate
56.0 - 84.0 = marked
above 84.0 = extreme




Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
unrinsed eyes
Basis:
mean
Time point:
24 h
Score:
5
Max. score:
80
Reversibility:
fully reversible within: 2 days
Irritation parameter:
cornea opacity score
Remarks:
unrinsed eyes
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
80
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Remarks:
unrinsed eyes
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
80
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Remarks:
unrinsed eyes
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
80
Reversibility:
not specified
Irritation parameter:
iris score
Remarks:
unrinsed eyes
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
10
Reversibility:
not specified
Irritation parameter:
iris score
Remarks:
unrinsed eyes
Basis:
mean
Time point:
other: 4 days
Score:
0
Max. score:
10
Reversibility:
not specified
Irritation parameter:
iris score
Remarks:
unrinsed eyes
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
10
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Remarks:
unrinsed eyes
Basis:
mean
Time point:
24 h
Score:
7.3
Max. score:
20
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
unrinsed eyes
Basis:
mean
Time point:
48 h
Score:
4.7
Max. score:
20
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
unrinsed eyes
Basis:
mean
Time point:
72 h
Score:
0.7
Max. score:
20
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
unrinsed eyes
Basis:
mean
Time point:
other: 4 days
Score:
0.7
Max. score:
20
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
unrinsed eyes
Basis:
mean
Time point:
7 d
Score:
0.7
Max. score:
20
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Remarks:
rinsed eyes
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
80
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Remarks:
rinsed eyes
Basis:
mean
Time point:
other: 4 days
Score:
0
Max. score:
80
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Remarks:
rinsed eyes
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
80
Reversibility:
not specified
Irritation parameter:
iris score
Remarks:
rinsed eyes
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
10
Reversibility:
not specified
Irritation parameter:
iris score
Remarks:
rinsed eyes
Basis:
mean
Time point:
other: 4 days
Score:
0
Max. score:
10
Reversibility:
not specified
Irritation parameter:
iris score
Remarks:
rinsed eyes
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
10
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Remarks:
rinsed eyes
Basis:
mean
Time point:
24 h
Score:
2
Max. score:
20
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Remarks:
rinsed eyes
Basis:
mean
Time point:
48 h
Score:
2
Max. score:
20
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Remarks:
rinsed eyes
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
20
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Remarks:
rinsed eyes
Basis:
mean
Time point:
other: 4 days
Score:
0
Max. score:
20
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Remarks:
rinsed eyes
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
20
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
80
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test item was found to cause minimal irritation at cornea and conjunctiva (redness, chemosis, discharge) when applied to the rabbit eye mucosa (primary irritation index 3.8). When the application site was rinsed, irritation was minimized (primary irritation index 0.8) with effects at conjunctiva (redness, chemosis). Findings in cornea were observed in one animal and healed by the second day. Redness of the conjunctiva occurred in all animals with unrinsed eyes and a score 1 effect was still observed in one animal at the last observation time point.

Any other information on results incl. tables

Table 1. Calculation of the primary eye irritation index

Time after exposure (days)

Mean Reaction Score

Unrinsed eyes

Rinsed eyes

Cornea

Iris

Conjunctiva

Cornea

Iris

Conjunctiva

1

5

0

7.3

0

0

2

2

0

0

4.7

0

0

2

3

0

0

0.7

0

0

 0

4

0

0

0.7

0

0

 0

7

0

0

0.7

0

0

 0

Subtotal

5

0

14.1

0

0

4

Total

19.1

4

Primary irritation index in unrinsed eyes

19.1 / 5 = 3.8

Primary irritation index in rinsed eyes

4 / 5 = 0.8

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was found to be not irritant to the eyes when rinsed 30 seconds after application.