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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
6 February - 3 June 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Lot No. of test material: 07-170-FIL-2/3
- Appearance: White powder
- Expiration date: May 2010
- Purity: 98.4%
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Nichols Rabbitry Inc., Lumberton, TX
- Age at study initiation: Approx. 13 weeks old
- Weight at study initiation: Males: 2.350 - 2.800 kg; Female: 2.325 kg
- Housing: Suspended, wire bottom, stainless steel cage; 1 animal per cage
- Diet: PMI Feeds Inc. Lab Rabbit Diet #5321; 8 oz daily
- Water: Municipal water supply available ad libitum from automatic water system
- Acclimation period: Not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 12 air changes/ hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: From: 12 February 2008 To: 15 February 2008

Test system

Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.50 mg of test substance (moistened with 0.5 mL water) was applied to the test site

VEHICLE
- Amount applied: Each dose of test substance was moistened with 0.5 mL of deionised water
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
2 males and 1 female
Details on study design:
TEST SITE
- Area of exposure: The test material was applied to the dorsal surface of the trunk and covered with a 4 ply, 2.5 x 2.5 cm surgical gauze patch.
- % coverage: An area was clipped of at least 8 x 8 cm
- Type of wrap: Each patch was secured in place with a strip of non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (orthopaedic stockinette) which was secured on both edges with strips of tape.

REMOVAL OF TEST SUBSTANCE
- Washing: The test sites were gently washed with room temperature tap water and a clean cloth to remove as much residual test material as possible.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
The test sites were observed for erythema and edema formation and any other dermal defects or irritation at 1, 24, 48 and 72 hours after unwrap.

SCORING SYSTEM: Draize
- Method of calculation:

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
other: All animals
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
other: All animals
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
other: All animals
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Erythema and edema were not observed at any time throughout the study. No other signs of irritation were observed during the study.
Other effects:
- Other adverse local effects: None
- Other adverse systemic effects: None

Any other information on results incl. tables

- Actual temperature: 18 - 22°C

- Actual relative humidity: 41 - 84% (Humidity was outside of the protocol range but did not affect the study outcome)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No evidence of skin irritation or corrosive effects were noted during the study. The primary irritation index obtained from the 1, 24, 48 and 72 hour observations was 0.0. Therefore, Formononetin is considered to be non-irritating to skin.