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
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:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: GAUKLER; D-6050 OFFENBACH/MAIN, FRG
- Weight at study initiation: 3.59 kg for the 3 tested females
- Housing: single in cage made of stainless steel with wire mesh walk floors. Floor area: 40 cm x 51 cm
- Diet: Kliba 341, 4MM; Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day); ad libitum
- Water: about 250 ml tap water per animal per day; ad libitum
- Acclimation period: at least 8 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): the animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20-24°C
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
single application to the conjunctival sac of the right eyelid; the substance is not washed out
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed

SCORING SYSTEM:
OECD; the substance was not washed out. Findings were recorded after 1, 24, 48, 78 hours, 8 days, 15 days and at the end of the observation period (21 days)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48-72-hour
Score:
0.7
Max. score:
4
Reversibility:
not fully reversible within: one animal with positive score (2) at the end of the observation period
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72-hour
Score:
0.1
Max. score:
2
Reversibility:
fully reversible within: only one animal with positive score (1) 48 hours after treatment but reversible within 72 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24-48-72-hour
Score:
1.9
Max. score:
3
Reversibility:
not fully reversible within: one animal with positive score (1) at the end of the observation period
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72-hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
see table 1
Other effects:
small retraction of the eyelids, pupil contracted, suppuration, marginal vascularization of the cornea and loss of cornea tissue were observed (see Table 1) and still present in 2 animals at the end of the observation period.

Any other information on results incl. tables

Table 1: results of acute eye irritation (OECD scores and additional symptoms

 

Readings

Animal

Cornea opacity

Iris

Conjunctiva

Symptoms

Redness

Swelling

1 hour

1

0

0

2

2

 

2

0

0

2

3

 

3

0

0

2

3

 

24 hours

1

0

0

2

1

RE / PC

2

1

0

2

2

 

3

1

0

2

2

 

48 hours

1

0

0

2

0

RE

2

1

1

2

2

RE / PC / S

3

1

0

2

1

PC / S

72 hours

1

0

0

2

0

RE

2

1

0

2

1

RE / PC / S

3

1

0

1

0

RE

8 days

1

0

0

0

0

RE

2

1

0

1

0

RE / PC / MV / S3

3

0

0

0

0

RE

15 days

1

0

0

0

0

RE

2

2

0

1

0

RE / PC / MV / S3

3

0

0

0

0

RE

21 days

1

0

0

0

0

RE

2

2

0

1

0

RE / PC / MV / S3

3

0

0

0

0

 

Mean 24-48-72-hour /animal

1

0.0

0.0

2.0

0.3

 

2

1.1

0.3

2.0

1.7

 

3

1.0

0.0

1.7

1.0

 

Total 24 -48 -72 -hour mean

 

0.7

0.1

1.9

1.0

 

RE: small retraction of the eyelids; PC: pupil contracted; S: Suppuration; MV: marginal vascularization of the cornea; S3: loss of cornea tissue

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Conclusions:
The mean scores were 0.7 for corneal opacity (1.0 for 2/3 rabbits and 0 for the third animal), 0.1 for iris lesions (0.3 for 1/3 animals and 0 for 2/3 animals), 1.9 for redness of the conjunctivae (2.0 for 2/3 and 1.7 for 1/3 animals) and 1.0 for edema formation (0.3, 1.7 and 1.0 for the individual rabbits). The mean scores calculated over all animals tested were below 2 for corneal opacity, below 1 for iris lesions, below 2.5 for redness of the conjunctivae and below 2 for edema formation and there were no individual animals with scores equal to the above values. However, because lesions were still present at the end of the observation period in one animal, the test substance is regarded as posing the risk of serious eye damage to white Vienna rabbits under the conditions chosen.
Executive summary:

The substance is legally classified for Eye Irrit. 2 (H319). However the data of this present key study is in support of a classification for Eye Dam. 1 (H318).