Phosphonium, triphenyl(3,7,11-trimethyl-2,4,6,10-dodecatetraenyl)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

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:

triphenyl[(2E,4E,6E)-3,7,11-trimethyldodeca-2,4,6,10-tetraen-1-yl]-λ⁵-phosphane

EC Number:

603-493-6

Cas Number:

131560-11-7

Molecular formula:

C33 H38 P

IUPAC Name:

triphenyl[(2E,4E,6E)-3,7,11-trimethyldodeca-2,4,6,10-tetraen-1-yl]-λ⁵-phosphane

Test material form:

semi-solid (amorphous): gel

Details on test material:

Charge: B 15S
Purity: 78.7 g/100 g (HPLC)
State: highly viscous gel

Specific details on test material used for the study:

Purity: 78.7 g1l00 g (HPLC)
Technikumscharge B 15S
Date of manufacturing. August 1998

Test animals

Species:

rabbit

Strain:

Himalayan

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

Route of application: The test substance was applied in a single dose to the intact untreated skin. The test patch was secured in position with a semiocclusie dressing. The test substance was removed at the end of the exposure period with Lutrol and Lutrol/water (1:1).
Olipping of the fur: At least 24 hours before the test, the fur was removed by clipping the dorsal part of the trunk of the animal(s). Only animals with healthy intact skin were used.
Application site: Upper third of the back or flanks.
Negative control: Untreated skin sites of the same animal.
Application volume: The test patch <2.5 cm x 2.5 cm) was moistened with a dose of 0.5 ml of the at about 50 degrees centigrade heated, undiluted test substance. Before application, it was cooled down to body temperature.

Exposure period: 4 h.
Observation period: 7 d animal 01 and animal 02. 14 d animal 03

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

48 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of moderate irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

2

Reversibility:

not reversible

Remarks on result:

probability of moderate irritation

Results 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

7 d

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of moderate irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

14 d

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of moderate irritation

Results 6

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of moderate irritation

Results 7

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 8

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 9

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

7 d

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of moderate irritation

Results 10

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of moderate irritation

Results 11

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

48 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of moderate irritation

Results 12

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 13

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

7 d

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of moderate irritation

Results 14

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14d

Remarks on result:

probability of severe irritation

Results 15

Irritation parameter:

edema score

Basis:

animal #1

Time point:

48 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14d

Remarks on result:

probability of moderate irritation

Results 16

Irritation parameter:

edema score

Basis:

animal #1

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14d

Remarks on result:

probability of moderate irritation

Results 17

Irritation parameter:

edema score

Basis:

animal #1

Time point:

7 d

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14d

Remarks on result:

probability of moderate irritation

Results 18

Irritation parameter:

edema score

Basis:

animal #1

Time point:

14 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Results 19

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 20

Irritation parameter:

edema score

Basis:

animal #2

Time point:

48 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 21

Irritation parameter:

edema score

Basis:

animal #2

Time point:

72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 22

Irritation parameter:

edema score

Basis:

animal #2

Time point:

7 d

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of moderate irritation

Results 23

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 24

Irritation parameter:

edema score

Basis:

animal #3

Time point:

48 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 25

Irritation parameter:

edema score

Basis:

animal #3

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of moderate irritation

Results 26

Irritation parameter:

edema score

Basis:

animal #3

Time point:

7 d

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of moderate irritation

Irritant / corrosive response data:

Necrosis , bleeding and white decolourization of application area was observed after 7 days in animals no. 1 and 2.

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

Under the test conditions chosen and considering the described findings the test substance gives indication of causing full thickness destruction of skin tissue as a result of an exposure period of 4 hours.

Executive summary:

The potential of the test substance to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 ml of the test substance to the intact skin of 3 Himalayan rabbits for 4 hours under sem.iocclusive dressing. The average score (24 to 72 hours) for irritation was calculated to be 2.6 for erythema and 2.6 for edema. Visual necrosis was observed in 2 animals 7 days after removal of the patches. The necrotic change of the skin was assessed by macroscopic pathology and histopathological examination indicating full thickness necrosis. The skin findings in the third animal were not reversible at study termination 14 days after removal of the patch. Under the test conditions chosen and considering the described findings the test substance gives indication of causing full thickness destruction of skin tissue as a result of an exposure period of 4 hours.