Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets scientific standards with acceptable restrictions (occlusive exposure for 24 hours).

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979
Reference Type:
publication
Title:
OECD SIDS 1,3-Dimethylurea (CAS: 96-31-1)
Author:
BASF AG
Year:
2003
Bibliographic source:
UNEP Publications
Report Date:
2003

Materials and methods

Principles of method if other than guideline:
Method: according Fed. Reg., 38, 187, § 1500.41, (27.09.1973)
Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. Usually, animals were treated for 1, 5 and 15 minutes and for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid or powdered and moistened test substance.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): N,N'-Dimethylurea; N,N'-Dimethylharnstoff
- Substance number: 77/21
- Physical state: cristalline
- Analytical purity: 97.5 %
- Impurities (identity and concentrations): minor components: ca. 1 % monomethylurea; ca. 1 % trimethylurea and 0.5 % water

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: breeder: M. Gaukler, Offenbach
- Age at study initiation: no data
- Mean weight at study initiation: ca. 2.87 kg
- Housing: no data
- Diet (e.g. ad libitum): Ssniff K, standard diet for rabbits and guinea pigs, Intermast GmbH, Soest, Germany, ad libitum
- Water (e.g. ad libitum): water, adlibitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- no data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipping
Vehicle:
water
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 0.5 g
- Concentration (if solution): 80 % aqueous preparation
Duration of treatment / exposure:
24 hour(s)
Observation period:
8 days
Number of animals:
3 males; 3 females
Details on study design:
TEST SITE
- Area of exposure: dorsal clipped skin
- Application: The test patch was covered with the substance preparation and applied to the skin.
- coverage: ca. 2.5 x 2.5 cm
- Type of wrap if used: Test patches were covered with a gummed linen cloth (5 x 5 cm), fixed with a thin adhesive tape and wraped with a gauze bandage.
During exposure, the animals were fixed and do not obtain neither feed nor water.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: according to the Draize scoring system, at 24 and 72 hours and on day 8.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
On intact skin, 2/6 animals showed very slight erythema, which was completely reversible within 8 days (mean Draize scores: 24 hr - 0.3; 72 hr - 0.2).
Edema was not observed at any time.
Other effects:
No toxic signs.

Any other information on results incl. tables

Table 1 Skin irritation  

Animal

Reading

Erythema

Edema

Additional findings

1

24 h

1

0

-

2

24 h

1

0

-

3

24 h

0

0

-

4

24 h

0

0

-

5

24 h

0

0

-

6

24 h

0

0

-

1

72 h

0

0

-

2

72 h

1

0

-

3

72 h

0

0

-

4

72 h

0

0

-

5

72 h

0

0

-

6

72 h

0

0

-

1

8 days

0

0

-

2

8 days

0

0

-

3

8 days

0

0

-

4

8 days

0

0

-

5

8 days

0

0

-

6

8 days

0

0

-

mean animal 1

24, 72 h

0.50

0.00

 

mean animal 2

24, 72 h

1.00

0.00

 

mean animal 3

24, 72 h

0.00

0.00

 

mean animal 4

24, 72 h

0.00

0.00

 

mean animal 5

24, 72 h

0.00

0.00

 

mean animal 6

24, 72 h

0.00

0.00

 

mean all animals

24, 72 h

0.33

0.00

 

Applicant's summary and conclusion

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