2-ethylhexyl 10-ethyl-4,4-dimethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

in vivo study in the rabbit. The existing in vivo data is considered to fulfil the in vitro skin irritation/corrosion requirement.

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl 10-ethyl-4,4-dimethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

EC Number:

260-829-0

EC Name:

2-ethylhexyl 10-ethyl-4,4-dimethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

Cas Number:

57583-35-4

Molecular formula:

C22H44O4S2Sn

IUPAC Name:

2-ethylhexyl 2-{[({2-[(2-ethylhexyl)oxy]-2-oxoethyl}sulfanyl)dimethylstannyl]sulfanyl}acetate

Details on test material:

- Physical state: liquid
- Analytical purity: 62.8%
- Purity test date: 2006-06-30
- Lot/batch No.: 2083498
- Expiration date of the lot/batch: 2008-11-01
- Stability under test conditions: stable
- Storage condition of test material: room temperature and humidity

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, Massachusetts, USA
- Age at study initiation: approx 14-18 weeks
- Weight at study initiation: 2.7-3.5 kg
- Housing: 1/cage in suspended wire cages
- Diet (e.g. ad libitum): PMI Rabbit Chow (Diet #5321) daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 deg C
- Humidity (%): 60-86%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hour light / 12 hour dark


IN-LIFE DATES: From: June 20, 2006 To: June 27, 2006

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/site
- Concentration (if solution): N/A


VEHICLE- no vehicle

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

2 males and 1 female

Details on study design:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10 x 10 cm
- Type of wrap if used: piece of fabric (semi-occlusive) secured with adhesive tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with paper towels saturated with tap water and blotted dry with paper towels
- Time after start of exposure: after 4 hours of exposure


SCORING SYSTEM:scored according to Draize technique

Results and discussion

In vivo

Results

Irritation parameter:

other: Modified Primary Irritation Index

Basis:

mean

Time point:

other: 4-hr

Score:

1.75

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Edema was absent at 72 hours and on Day 7; Erythema was absent on Day 7

Irritant / corrosive response data:

Erythema was absent to well defined at 60 minutes, 24 hours and 48 hours following the 4 hour exposure. Erythema was absent to very slight at 72 hours and absent on day 7. Edema was absent to very slight at 60 minutes following the 4 hour exposure and absent to well defined at 24 and 48 hours. Edema was absent at 72 hours and on Day 7.

Other effects:

There were no abnormal physical signs noted during the observation period.
All body weight changes were normal.

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: USEPA Review Manual, Chapter 8: Precautionary Labeling (1997)

Conclusions:

The test substance is a dermal irritant with a modified Primary Irritation Index of 1.75.

Executive summary:

To determine the irritant or corrosive effects of the test substance when applied dermally. The study followed OECD test guideline 404. Since the test substance was not expected to produce severe irritation or corrosion, three healthy New Zealand White rabbits (2 males-1 female) were dosed dermally with the test substance. The substance (0.5 mL) was applied dermally to one intact site/rabbit. The test substance was kept in contact with the skin for 4 hours at which time the wrappings were removed. Dermal reactions were scored at 60 minutes after removal of the wrappings. Reactions were scored again at 24, 48 and 72 hours and on Day 7. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Body weights were recorded pretest, at 72 hours and at termination. A modified Primary Irritation Index was calculated using the 60 minute, 24, 48 and 72 hour scoring intervals.

Erythema was absent to well defined at 60 minutes, 24 hours and 48 hours following the 4 hour exposure. Erythema was absent to very slight at 72 hours and absent on day 7. Edema was absent to very slight at 60 minutes following the 4 hour exposure and absent to well defined at 24 and 48 hours. Edema was absent at 72 hours and on Day 7. There were no abnormal physical signs noted during the observation period. All body weight changes were normal. The test substance is a dermal irritant.