diuron (ISO); 3-(3,4-dichlorophenyl)-1,1-dimethylurea

Skin irritation / corrosion

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

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Diuron

EC Number:

206-354-4

EC Name:

Diuron

Cas Number:

330-54-1

Molecular formula:

C9H10Cl2N2O

IUPAC Name:

3-(3,4-dichlorophenyl)-1,1-dimethylurea

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 or test system 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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

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).