Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD).

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)
Version / remarks:
adopted May 12th, 1981
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Coffein (Caffeine)
No further data.

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, Germany
- Weight at study initiation: 3.18 kg (animal no. 1, male); 2.48 kg (animal no. 2, female); 2.95 kg (animal no. 3, male)
- Housing: individually in stainless steel cages with wire mesh floors
- Diet: Kliba 341, 4 mm (Klingentalmühle, CH-4303 Kaiseraugst, Switzerland); ca. 130 g/animal/day
- Water: tap water, ca. 150 ml/animal/day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml bulk volume (ca. 56 mg) of the comminuted test substance
Duration of treatment / exposure:
single application to the conjunctival sac of the right eyelid without rinsing
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of n=3
Time point:
other: 24 - 72 h
Score:
0.9
Max. score:
1
Reversibility:
not fully reversible within: 8 days (1 animal only)
Irritation parameter:
iris score
Basis:
mean
Remarks:
of n=3
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of n=3
Time point:
other: 24 - 72 h
Score:
1.6
Max. score:
2
Reversibility:
not fully reversible within: 8 days (1 animal only)
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of n=3
Time point:
other: 24 - 72 h
Score:
0.6
Max. score:
2
Reversibility:
fully reversible within: 72 h

Any other information on results incl. tables

Table: Individual and mean Draize scores

Readings

Animal

no.

Cornea

opacity

Iris

Conjunctivae

Symptoms

Redness

Swelling

1 h

1

2

3

0

1

1

0

0

0

2

2

2

1

2

2

24 h

1

2

3

1

1

1

0

0

0

2

2

2

1

1

2

RE

48 h

1

2

3

1

1

1

0

0

0

2

1

2

1

0

0

RE

72 h

1

2

3

0

1

1

0

0

0

1

1

1

0

0

0

RE

8 d

1

2

3

0

1

0

0

0

0

0

1

0

0

0

0

RE

RE

mean

mean

mean

1

2

3

0.7

1.0

1.0

0.0

0.0

0.0

1.7

1.3

1.7

0.7

0.3

0.7

mean

1-3

0.9

0.0

1.6

0.6

Symptoms: RE = small retractions in the eyelid

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Classification: not irritating
Executive summary:

The undiluted test substance was not irritating to the eye of rabbits.