Caffeine

Eye irritation

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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted May 12th, 1981

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Caffeine

EC Number:

200-362-1

EC Name:

Caffeine

Cas Number:

58-08-2

Molecular formula:

C8H10N4O2

IUPAC Name:

1,3,7-trimethyl-3,7-dihydro-1H-purine-2,6-dione

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

Results

Results 1

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)

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of n=3

Time point:

other: 24 - 72 h

Score:

0

Max. score:

0

Results 3

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)

Results 4

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.