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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin 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 404); 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 404 (Acute Dermal 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

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Iffa-Credo, St Germain sur L'Arbresle, 69210, France.
- Weight at study initiation: weight range from 2.8 to 3.1 kg.
- 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: 5 days .


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15°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

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
500 mg/animal
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: hydrophilic gauze patch which was secured by a semi-occlusive hypoallergenic dressing.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was gently removed with sterile water.
- Time after start of exposure: 4 h.

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: no effects
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
8
Reversibility:
other: no effects

Any other information on results incl. tables

No mortalities occurred during the course of the study. There were no treatment-related clinical signs or behavioral abnormalities. The body weight evolution of the animals was unaffected by treatment.

No erythema and no edema were observed (score 0 according to the OECD/Draize scheme).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information