Reaction mass of Di-μ-thio-[{bis(2-ethylhexyl)carbamato-S,S’}oxo molybdenum(V)], Di-μ-thio-[{(2-ethylhexyl)carbamato-S,S’}{(branched ditridecyl)carbamato-S,S’}oxo molybdenum(V)] and Di-μ-thio-[{bis(branched ditridecyl)carbamato-S,S’}oxo molybdenum(V)]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 to 22 September 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted in a GLP compliant laboratory according to accepted regulatory guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

S-900

IUPAC Name:

S-900

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Details on test material:

- Name of test material (as cited in study report): S-900
- Physical state: dark brown paste
- Lot/batch No.: 02869
- Storage condition of test material:room temperature In the dark, handled under non-actinic lighting only
- Other:

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: reputable commercial supplier
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.63 - 2.89kg
- Housing: The animals were individually housed in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days minimum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 -23C
- Humidity (%): 30-70%
- Air changes (per hr): ca 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 h light: 12h dark

IN-LIFE DATES: From: To: 08-22 September 1999

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Remarks:

None

Controls:

no

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 h

Observation period:

72h - Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal flank area
- % coverage: not specified - area of 2.5cm x 2.5cm tested
- Type of wrap if used:A quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape (BLEN DERM: approximate size 2.5 cm x 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material removed by gentle swabbing with cotton wool soaked in acetone.
- Time after start of exposure: 4h

SCORING SYSTEM:
The test sites were scored according to the following scale from Draize J H, (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.31.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

other: moderate desquamation on Day 14

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

other: moderate desquamation on Day 14

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.66

Max. score:

2

Reversibility:

other: moderate desquamation on Day 14

Results 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.66

Max. score:

2

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.66

Max. score:

1

Reversibility:

fully reversible

Irritant / corrosive response data:

Reversibility of any observed effect: Changes not fully reversible within 14 days

Other effects:

Crust formation which prevented accurate evaluation of erythema and oedema was noted at all treated skin sites at the 7-day observation. Moderate desquamation was noted at all treated skin sites at the 14-day observation.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test material, S-900, produced a primary irritation. index of 3.2 and was classified as a MODERATE IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material produced positive criteria in 2/3 rabbits according to the EU labelling regulations and was classified as IRRITANT to rabbit skin.