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EC number: - | CAS number: -
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-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:
- 2 000
- 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
- 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).
Constituent 1
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.
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