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)]

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

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.

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

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

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

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.66

Max. score:

2

Reversibility:

fully reversible

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20-25 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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: reputable commercial supplier
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.54-2.84kg
- 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): 12h light: 12h dark

IN-LIFE DATES: From: To: 20-25 September 1999

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

.1 ML

Duration of treatment / exposure:

72h

Observation period (in vivo):

72h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed
- Time after start of exposure:

SCORING SYSTEM: according to the numerical evaluation given in Appendix I, (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 pA8 to 49).

TOOL USED TO ASSESS SCORE: ophthalmascope

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 1 day

Other effects:

A single instillation of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. Alopecia (loss of fur around the treated eye) was noted in all animals. No ocular effects were noted at the 24-hour observation.

Interpretation of results:

GHS criteria not met

Executive summary:

The test material, S-900, produced a maximum group mean score of 4.7 and was classified as a MINIMAL IRRITANT (CLASS 3 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified Kay and Calandra classification system.

The test material did not produce positive criteria in any rabbit according to the EU labelling regulations.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The skin irritation study produced positive criteria in 2 out of three rabbits and was classified as irritant to rabbit skin.

Justification for selection of skin irritation / corrosion endpoint:

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.

Justification for selection of eye irritation endpoint:

The test material, S-900, produced a maximum group mean score of 4.7 and was classified as a MINIMAL IRRITANT (CLASS 3 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified Kay and Calandra classification system.

The test material did not produce positive criteria in any rabbit according to the EU labelling regulations.

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

The skin irritation study produced positive criteria in 2 out of three rabbits and was classified as irritant to rabbit skin