Caffeine

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 404 (Acute Dermal 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): Caffeine
No further data.

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, Germany
- Weight at study initiation: 3.20 kg (animal no. 1; male); 3.13 kg (animal no. 2; male); 3.00 kg (animal no. 3; female)
- Housing: individually in stainless steel cages
- Diet: Kliba 341, 4 mm; Klingentalmühle, CH-4303 Kaiseraugst, Switzerland; ca. 130 g per day
- Water: tap water; ca. 250 ml/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

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: untreated skin sites of the same animals

Amount / concentration applied:

Concentration: 50 %
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 500 mg of an aqueous suspension
- Concentration: 50% (w/w) suspension

Duration of treatment / exposure:

4 hour(s)

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: upper third of the back or flanks, size: ca. 2.5 cm x 2.5 cm
- Type of wrap if used: four layers of absorbent gauze plus porous bandage
A test patch (ca. 2.5 cm x 2.5 cm in size) was covered with a ca. 0.5-mm layer of the 50% suspension. Thus ca. 500 mg of the suspension was applied.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

of n=3

Time point:

other: 24 - 72 hours

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of n=3

Time point:

other: 24 - 72 hours

Score:

0

Results 3

Irritation parameter:

edema score

Basis:

mean

Remarks:

of n=3

Time point:

other: 24 - 72 h

Score:

0

Irritant / corrosive response data:

No erythema and no edema was observed. All scores were zero for each endpoint in each animal at any reading. No other symptoms or findings were noted.

Any other information on results incl. tables

Table: Draize scores

Readings	Animal	Intact skin
		erythema	edema	symptoms
4 h	1 2 3	0 0 0	0 0 0	none none none
24 h	1 2 3	0 0 0	0 0 0	none none none
48 h	1 2 3	0 0 0	0 0 0	none none none
72 h	1 2 3	0 0 0	0 0 0	none none none
mean mean mean	1 2 3	0.0 0.0 0.0	0.0 0.0 0.0
mean	1-3	0.0	0.0

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 test substance was not irritating when applied as a 50% aqueous suspension to the intact skin of rabbits.