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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:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Relatively well reported study, no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid - liquid: suspension
Details on test material:
Name: TRILON B-CU 15

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: no data
- Weight at study initiation: two males (2.62 and 2.73 kg), one female (2.96 kg)
- Housing: 1 per cage (stainless steel)
- Diet (e.g. ad libitum): about 130 g per animal per day
- Water (e.g. ad libitum): about 250 mL per animal per day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Test system

Vehicle:
water
Controls:
no
Amount / concentration applied:
0.1 ml bulk volume was applied (ca. 61 mg of the comminuted test substance)
Duration of treatment / exposure:
Single application
Observation period (in vivo):
Up to 8 days; scoring at 1, 24, 48, and 72 h and 8 days after application
Number of animals or in vitro replicates:
3 (2 males, 1 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: not applicable

SCORING SYSTEM: according to 83/467/EEC

TOOL USED TO ASSESS SCORE: no info

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1,2,3
Time point:
24/48/72 h
Score:
0.89
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal: 1,2,3
Time point:
24/48/72 h
Score:
0.22
Max. score:
2
Reversibility:
fully reversible within: 8 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: 1,2,3
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: 1,2,3
Time point:
24/48/72 h
Score:
0.89
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
See table below
Other effects:
No info

Any other information on results incl. tables

Summary of ocular lesions

 

Anim.

No.

Effect

Hours

Days after application

Mean

score cornea

Days

1/2/3

Mean score iritis

Days 1/2/3

 

Mean score redness Days 1/2/3

Mean score chemosis Days 1/2/3

1

1

2

3

8

 

 

 

 

 

1 (M)

Cornea

Iris

Redness

Chemosis

0

0

2

2

1

0

2

1

1

0

2

0 PC

1

0

1

0

0

0

0

0

 

1.00

 

0

 

 

1.67

 

 

0.33

2 (F)

Cornea

Iris

Redness

Chemosis

0

0

2

2

1

0

2

2

1

0

1

1

0

0

1

0

0

0

0

0

 

0.67

 

0

 

 

1.33

 

 

1.00

3 (M)

Cornea

Iris

Redness

Chemosis

0

0

2

2 PC

1

0

2

2 PC/S

1

1

2

1 PC/S/DC

1

1

2

1 PC

1

0

1

0

 

1.00

 

0.67

 

 

2.00

 

 

1.33

Mean all anim.

 

 

 

 

 

 

 

0.89

0.22

1.67

0.89

PC = pupil contracted, DC= detachment of the cornea, S = suppuration

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Because two animals out of three showed corneal opacity >= 1 calculated as the mean score following grading at 24, 48 and 72 h after instillation and is expected to be fully reversible within an observation period of 21 days, the test material needs to be classified as eye irritant Cat. 2 (2A).