Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 Dec 1996 - 20 Dec 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diuron TC
- Substance type: solid
- Physical state: white powder at RT
- Analytical purity: 99.2%
- Purity test date: 1997-03-08
- Lot/batch No.: 212/02/96
- Expiration date of the lot/batch: 98-02-12
- Stability under test conditions: stable at room temperature
- Storage condition of test material: 15 - 23°C in the toxicology chemical store
- Other: pH in a 1% aqueous dispersion: 6,34

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: B David
- Age at study initiation: not stated
- Weight at study initiation: 2986 - 3170 g
- Housing: standard stainless steel cages
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24
- Humidity (%): 44 - 56
- Air changes (per hr): 15 times
- Photoperiod (hrs dark / hrs light): artificial lightning; 12 h dark/12 h light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: close-clipping and use of depilation cream
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of powder


Duration of treatment / exposure:
4 h
Observation period:
72 h after patch removal
Number of animals:
3 per group
Details on study design:
TEST SITE
- Area of exposure: dorsal area and the trunk (approx. 6 cm2)
- Type of wrap if used: cotton gauze patch (2 cm x 2 cm), held in place with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with purified water
- Time after start of exposure: 4h

SCORING SYSTEM:
Scores according to Draize were attributed for erythema and oedema

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Other effects:
Body weight was normal

Any other information on results incl. tables

Table1: Summary of results of skin irritation study in rabbits

Score (average animals investigated)

Time

Erythema

Oedema

Average score
(0 to maximum 4)

60 min

0

0

24 h

0

0

48 h

0

0

72 h

0

0

Other times

none

-

-

Average score

24h, 48h, 72h

0

0

Reversibility:

n.a.*

n.a.

Average time for reversibility

n.a.

n.a.

* not applicable

No signs of erythema or oedema were observed at any of the time points in any of the rabbits.

Diuron is therefore considered as not irritating

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

In the reliable study which was conducted according to OECD 404 female rabbits were dermally exposed to 0.5 g of Diuron. No signs of erythema or oedema were observed (Sharp 1997).