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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Jan 1997 - 31 Jan 1997
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 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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
- Physical state: solid, white powder
- Analytical purity: 99.2%
- Purity test date: 1997-03-08
- Lot/batch No.: 212/02/96
- Expiration date of the lot/batch: 1998-02-12

- Stability under test conditions: stable at room temperature
- Storage condition of test material: 15 - 23 °C
- other: pH of 1% aqueous dispersion: 6,34

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Billy David
- Age at study initiation: not stated
- Weight at study initiation: 2077 g - 2331 g
- Housing: individually in standard stainless steel cages
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 25
- Humidity (%): 45 - 60
- Air changes (per hr): 15 times
- Photoperiod (hrs dark / hrs light): artificial light (12 h dark/ 12 h light)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: right eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
administered once in the left eye conjunctival sac
Observation period (in vivo):
3 days after instillation
Number of animals or in vitro replicates:
3 per group
Details on study design:
REMOVAL OF TEST SUBSTANCE
- no irrigation was performed

SCORING SYSTEM: after Draize evaluation criteria

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Other effects:
Clinical signs: no effects
Body weight was normal except one rabbit lost weight due to a stress reaction.

Applicant's summary and conclusion

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

In a reliable eye irritation study according to OECD 405 rabbits were exposed to 0.1 g of Diuron. The substance did not cause any effects with regard to corneal opacity or iris lesions. Only very slight conjunctival redness and oedema were observed but these effects were fully reversible within 72 h (Sharp, 1997).