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Skin irritation / corrosion

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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-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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

Constituent 1
Reference substance name:
Albrite CS1
IUPAC Name:
Albrite CS1
Constituent 2
Reference substance name:
hydrogen sulfate;tetrakis(hydroxymethyl)phosphanium;urea
EC Number:
613-239-6
Cas Number:
63502-25-0
Molecular formula:
Not applicable
IUPAC Name:
hydrogen sulfate;tetrakis(hydroxymethyl)phosphanium;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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
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.