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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
6-amino-1,3-dimethyluracil
EC Number:
229-662-0
EC Name:
6-amino-1,3-dimethyluracil
Cas Number:
6642-31-5
Molecular formula:
C6H9N3O2
IUPAC Name:
6-amino-1,3-dimethylpyrimidine-2,4(1H,3H)-dione
Details on test material:
- Name of test material (as cited in study report):
1,3-Dimethyl-4-aminouracil, techn.
- Physical state: solid
- Lot/batch No.: 02064

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: mean: female: 2.45 kg; male: 2.54 kg
- Housing: 1 rabbit per cage
- Diet (e.g. ad libitum): about 130 g per animal per day
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: at least 8 days


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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
Concentration: 50 %
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50% aqueous formulation (w/w)


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50%
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5cm x 2.5cm
- Type of wrap if used: test patches were secured in position with a porous dressing: four layers of absorbent gauze and porous bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): 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:
erythema score
Basis:
mean
Time point:
other: 4 hours
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 hours
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Remarks on result:
other: 24 - 72hours
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Remarks on result:
other: 24 - 72hours

Any other information on results incl. tables

Animal number

1

2

3

Body weight

2.54

2.41

2.49

Sex

male

female

female

Readings

Animal

Edema (score)

Erythema (score)

4 hours

1

0

0

2

0

0

3

0

0

24 hours

1

0

0

2

0

0

3

0

0

48 hours

1

0

0

2

0

0

3

0

0

72 hours

1

0

0

2

0

0

3

0

0

Evaluation of erythema and edema:

0 = none

1 = very slight

2 = well-defined

3 = moderate to sever

4 = severe to very severe

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU