[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP Study, OECD compliance. however, no cerficate of analysis is available in the study report

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

2000-04-26

Test material

Test material information

Constituent 1

Reference substance name:

Tetrakis(hydroxymethyl)phosphonium sulphate (2:1) and its oligomerisation products with urea

Molecular formula:

Not applicable

IUPAC Name:

Tetrakis(hydroxymethyl)phosphonium sulphate (2:1) and its oligomerisation products with urea

Test material form:

other: liquid

Details on test material:

Name used in the report: Albrite CS1 (Albrite CS1 was the commercial name of Phosphonium, tetrakis (hydroxymethyl)-sulphate (2:1); polymer with urea).

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.50 to 2.75 kg
- Housing: Individually housed in suspended metal cages
- Diet (e.g. ad libitum): free access to food (STANRAB SQC Rabbit diet, special diets services Ltd, witham, Essex, UK)
- Water (e.g. ad libitum): free access
- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17°C to 23°C
- Humidity (%): 30% to 70%
- Air changes (per hr): At least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): Cycle 12/12 (Continuous light fromm 6:00 to 18:00)

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

1h, 24h, 48h and 72h after the removal of the patch

Number of animals:

3 males

Details on study design:

TEST SITE
the substance was introduced under a 2.5cm x 2.5 cm cotton gauze patch and placed in position on the short skin. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of each rabbit wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.

SCORING SYSTEM:
Draize method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Very slight erythema was noted at two treated skin sites at the 1-hour observation.
An isolated incident of very slight oedema was noted at one treated skin site at the 1-hour observation.

Any other information on results incl. tables

Table 73.1/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Skin Reaction	Observation time	Individual Scores- Rabbit Number and Sex (BW : Kg)			Total
		178 Male (2.75)	94 Male (2.50)	58 Male (2.73)
Erythema / Eschar formation	1 hour	0	1	1	(2)
	24 hours	0	0	0	0
	48 hours	0	0	0	(0)
	72 hours	0	0	0	0
Oedema Formation	1 hour	0	0	1	(1)
	24 hours	0	0	0	0
	48 hours	0	0	0	(0)
	72 hours	0	0	0	0
Sum of 24 and 72 hour reading (S) : 0
Primary Irritation Index (S/6): 0/6 = 0.0
Classification: NON-IRRITANT

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions of this study, no dermal irritation was elicited by the test substance application throughout the observation period in any animal. The scores for both erythema and oedema are 0 for all animals. Therefore, the test substance is considered as not irritating to skin.

Executive summary:

In a primary dermal irritation study performed according to the OECD 404 guidelines and in compliance with GLP, three animals (males) were dermally exposed to 0.5mL of ALBRITE CS1 for 4 hours (Albrite CS1 was the commercial name of Phosphonium, tetrakis (hydroxymethyl)-sulphate (2:1); polymer with urea).

Cutaneous reactions were observed approximately 1, 24, 48 and 72 hours after removal of the dressing. The mean values of the scores for erythema and oedema were calculated for each animal.

No dermal irritation was elicited by product application throughout the observation period in any animal. The scores for both erythema and oedema are 0 for all animals.The substance seems not to be irritant via skin exposure.

Under the test conditions of this study, the substance ALBRITE CS1 (Phosphonium, tetrakis (hydroxymethyl)-sulphate (2:1); polymer with urea) was considered as not irritating to skin and not classified according to the criteria of the CLP Regulation (EC) N°1272/2008.