Simazine

Skin irritation / corrosion

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

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Simazine

EC Number:

204-535-2

EC Name:

Simazine

Cas Number:

122-34-9

Molecular formula:

C7H12ClN5

IUPAC Name:

6-chloro-N2,N4-diethyl-1,3,5-triazine-2,4-diamine

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 or test system 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

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

other: All animals

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

other: All animals

Time point:

other: All time points

Score:

0

Results 3

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.