Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 - 30 April 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
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:
TEST MATERIAL
- Test material: Simazine Technical
- Description: White powder
- Lot No.: 1022066
- Purity: Not provided to testing facility

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability: Not provided to testing facility

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompsons Station, TN
- Age at study initiation: approx. 2 months
- Weight at study initiation: Male: 2.450 kg; Female: 2.425 - 2.525 kg
- Housing: suspended, wire bottom, stainless steel cages; one animal per cage
- Diet: PMI Feeds, Inc.™ Lab Rabbit Diet Formula #5321, ~8 oz. daily
- Water: municipal water supply available ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C (actual 18 - 22°C)
- Humidity (%): 30 - 70% (actual 41 - 91%)
- Air changes (per hr): 10 - 12
- Photoperiod (hrs dark / hrs light): 12 hour light/ dark cycle

IN-LIFE DATES: From: 27 April 2010 To: 30 April 2010

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mg of test substance

VEHICLE
- Amount(s) applied: 0.5 mL of deionised water
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 animals (1 male and 2 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Each 4 ply, 2.5 x 2.5 cm surgical gauze patch was held in place with a strip of non-irritating adhesive tape. The entire trunk of the animal was loosely wrapped with a semi-permeable dressing secured on both edges with 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 substance as possible.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after unwrapping the test sites

SCORING SYSTEM:
- Method of calculation: Draize

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
Irritation parameter:
erythema score
Basis:
other: All animals
Time point:
other: All time points
Score:
0
Irritation parameter:
edema score
Basis:
other: All animals
Time point:
other: All time points
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.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance, Simazine Technical, is evaluated as a "non-irritant" to skin under the conditions of the study.