Registration Dossier

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:
OECD Guideline 404 (Acute Dermal 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): Caffeine
No further data.

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals 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

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
of n=3
Time point:
other: 24 - 72 hours
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of n=3
Time point:
other: 24 - 72 hours
Score:
0
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.