Phosphonium, tetraphenyl-, salt with 4,4'-sulfonylbis[phenol], compd. with 4,4'-sulfonylbis[phenol] (2:2:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was performed between 21 January 2004 and 30 January 2004.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

484-440-2

EC Name:

-

Cas Number:

502157-74-6

Molecular formula:

C84H68O12S3P2

IUPAC Name:

4-(4-hydroxybenzenesulfonyl)phenol bis(tetraphenylphosphanium) bis(4-(4-hydroxybenzenesulfonyl)benzen-1-olate)

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Description, Identification and Storage Conditions
Sponsor's identification SBCAT-03
Description white powder
Batch number UK.030622B
Date received 09 October 2003
Storage conditions room temperature in the dark

Data relating to the identity, purity and stability of the test material are the responsibility of the Sponsor.
Preparation of Test Material
For the purpose of the study the test material was used as supplied.
The absorption of the test material was not determined.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Three New Zealand White rabbits were supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK. At the start of the study the animals were in the weight range of2.0 to 3.5 kg and were twelve to twenty weeks old. After an acclimatisation period of at least five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended metal cages. Free access to mains drinking water and food (Certified Rabbit Diet (Code 5322) supplied by BCM IPS Limited, London, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18 :00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Amount / concentration applied:

0.5g of the test material, moistened with 0.5 ml of distilled water, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin.

Duration of treatment / exposure:

One rabbit was initially treated. Three suitable sites were selected on the back of the rabbit. At each test site a quantity of 0.5g of the test material, moistened with 0.5 ml of distilled water, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset and the animal was returned to its cage for the duration of the exposure period.
One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application. Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
After consideration of the skin reactions produced in the first animal, two additional animals were treated with 0.5 g oftest material moistened with 0.5 ml of distilled water. One patch was applied to the back of each rabbit, and was allowed to remain in contact with the skin for a period of four hours.

Observation period:

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 and scored. See "any other information".

Number of animals:

3

Details on study design:

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" ( adopted 24 April 2002)
Commission Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

48 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

48 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Time point:

48 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 10

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 11

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

48 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 12

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 13

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 14

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 15

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 16

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 17

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

48 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 18

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 19

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24/72h

Score:

0

Max. score:

8

Reversibility:

fully reversible

Irritant / corrosive response data:

4-Hour Exposure Period
The individual scores for erythema/eschar and oedema are given in "Any other information".
Very slight erythema was noted at one treated skin site one hour after patch removal.
Two treated skin sites appeared normal throughout the study and the remaining treated skin site appeared normal at the 24-hour observation.
1-Hour Exposure Period
The individual scores for erythema/eschar and oedema are given in Appendix 1.
No evidence of skin irritation was noted during the study.
3-Minute Exposure Period
The individual scores for erythema/eschar and oedema are given in "Any other information".
No evidence of skin irritation was noted during the study.

Any other information on results incl. tables

Individual Skin Reactions Following 4-Hour Exposure

Skin Reaction	Observation Time	Individual Scores - Rabbit Number and Sex			Total
		53 Male	95 Male	96 Male
Erythema/Eschar Formation	1 Hour 24 Hours 48 Hours 72 Hours	0 0 0 0	0 0 0 0	1 0 0 0	(1) 0 (0) 0
Oedema Formation	1 Hour 24 Hours 48 Hours 72 Hours	0 0 0 0	0 0 0 0	0 0 0 0	(0) 0 (0) 0
Sum of 24 and 72-hour Readings (S):           0
Primary Irritation Index (S/6):                        0/6 = 0.0
Classification:                                                    NON-IRRITANT

 

Individual Skin Reactions Following 1-Hour and 3-Minute Exposures

Skin Reaction	Observation Time	Individual Scores · Rabbit Number and Sex
		53 Male
		1 -Hour Exposure	3-Minute Exposure
Erythema/Eschar Formation	1 Hour 24 Hours 48 Hours 72 Hours	0 0 0 0	0 0 0 0
Oedema Formation	1 Hour 24 Hours 48 Hours 72 Hours	0 0 0 0	0 0 0 0

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material produced a primary irritation index of 0.0 and was classified as
NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive
effects were noted.

Executive summary:

Introduction. The study was performed to assess the irritancy potential of the test material to the
skin of the New Zealand White rabbit. The method was designed to meet the requirements of the
following:
• OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion"
( adopted 24 April 2002)
• Commission Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation)
Results. A single 4-hour, semi-occluded application of the test material to the intact skin of three
rabbits produced an isolated incident of very slight erythema one hour after patch removal.
3-minute and I-hour semi-occluded applications of the test material to the intact skin of one rabbit
produced no evidence of skin irritation.
Conclusion. The test material produced a primary irritation index of 0.0 and was classified as
non-irritant to rabbit skin according to the Draize classification scheme.