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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 405); GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

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:
5-amino-4-({5-amino-3-cyano-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-1H-pyrazol-4-yl}disulfanyl)-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-1H-pyrazole-3-carbonitrile
EC Number:
603-434-4
Cas Number:
130755-46-3
Molecular formula:
C22 H8 Cl4 F6 N8 S2
IUPAC Name:
5-amino-4-({5-amino-3-cyano-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-1H-pyrazol-4-yl}disulfanyl)-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-1H-pyrazole-3-carbonitrile
Details on test material:
- Name of test material (as cited in study report): Disulfide / MB 46307 / RPA 98028 Intermediate of Fipronil (MB 46030).
- Physical state: yellow powder.
- Analytical purity: 97.2 %.
- Purity test date: 23-May-1995.
- Lot/batch No.: 95-4023.
- Storage condition of test material: The test substance was stored in an air-tight, light-resistant container at room temperature.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Iffa-Credo, St Germain sur L'Arbresle, 69210, France.
- Housing: individually in plastic cages.
- Diet: Certified Pellet diet 112C (Usine d´Alimentation Rationnelle, Villemoisson-sur-Orge, 91360 Epinay-sur-Orge, France) ad libitum.
- Water: filtered and softened water from the municipal water supply, ad libitum.
- Acclimation period: 12 days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17°C - 21°C.
- Humidity (%): 40% - 60%.
- Air changes (per hr): 10 to 15 air changes per hour (average, not monitored).
- Photoperiod (hrs dark / hrs light): 12-hour light, 12-hour dark cycles.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal served as control
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
The eyes were not rinsed after administration of the test substance.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects

Any other information on results incl. tables

Findings animal 1/2/3 (undiluted test substance):

 Time   Opacity Iritis   Conjunctival  Erythema  Conjunctival Chemosis                  
1 h 0/0/0 0/0/0 2/2/2 0/0/1                  
24 h 0/0/0 0/0/0 1/0/0 0/0/0                  
48 h

0/0/0

0/0/0 1/0/0 0/0/0                  
72 h 0/0/0 0/0/0 1/0/0 0/0/0                  
5 d 0/0/0 0/0/0 1/0/0 0/0/0                  
7 d 0/0/0 0/0/0 0/0/0 0/0/0                  
Mean: 24 h-48 h-72 h  0/0/0  0/0/0  1/0/0  0/0/0                  

MB 46307 induced no iridial or corneal changes. A slight redness of the conjunctivae was observed in 3/3 rabbits 1 h after instillation of the test substance. This observed ocular reaction was reversible on Day 2 for 2/3 animals and on Day 6 for the third animal.

Furthermore, one rabbit exhibited a slight and reversible chemosis of the conjunctivae, 1 h after instillation of the test substance (reversible within 24 h).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information