Registration Dossier
Registration Dossier
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EC number: 701-186-2 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 8th July 1981 to 11st July 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Test method is similar to OECD guideline 404. No GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium polysulfide aluminosilicate with a SOD-type framework structure
- EC Number:
- 701-340-9
- Molecular formula:
- |Na+6-x+y+z (S2•-)y(S3•-)z|[Al6-x Si6+x O24] - SOD Where: 6 ≤ 6-x+y+z ≤ 8 0 ≤ x ≤ 1.2 1 ≤ y+z ≤ 2
- IUPAC Name:
- Sodium polysulfide aluminosilicate with a SOD-type framework structure
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Physical state: a blue powder
Constituent 1
- Specific details on test material used for the study:
- Lot/batch nº: 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Recognised breeders whose premises have been inspected by Toxicol Laboratories- Weight at study initiation: 2.55-2.66 Kg- Housing: Grid bottomed galvanised metal cages- Diet (e.g. ad libitum): ninety to ninety five grams of a commercially available pelleted rabbit diet (Product Ref.16934, Spillers Agriculture Limited) for each animal at a similar time each day- Water (e.g. ad libitum): an automatic watering system provided a constant supply of drinking water to the cagesENVIRONMENTAL CONDITIONS- Temperature (°C): air -conditioned room- Photoperiod (hrs dark / hrs light): 14 hours light/10 hours dark per day
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0,5g aliquots of the test material were moistened with 0,5ml sterile distilled water.
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- One hour was allowed to permit any irritation from the adhesive tapes 24 hour observation72 hour observation
- Number of animals:
- 6
- Details on study design:
- TEST SITE-Area shaved: 10% of the total dorsal surface area. The left flank was then lightly abraded with the point of a 25x0.6mm sterile disposable hypodermic needle.-Area of exposure: 0.5g of the test sample was applied to each of two 2.5cm square surgical lint pads attached to "Sleek" plastic adhesive wrapping (one square with abraded skin and other square with intact skin)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritant/corrosive effects were noted
- Other effects:
- No general toxic effects were noted
Any other information on results incl. tables
No irritant/corrosive effects were noted
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is considered as non-irritating to the skin.. The test material is not classify as a "primary irritant to the skin". It would be regarded as a mild irritant to the skin of the albino rabbit according to the Draize system of classification.
- Executive summary:
The aim of this study was to investigate the degree of irritation produced to the abraded and intact skin of 6 albino rabbits following 24 hours occluded contact with the test material. The procedure used is that described in the U.S.Federal Register, 1973, Vol.38,No.187, Section 1500:41 (similar to OECD Guideline 404). 0.5 g of the test sample was applied to each of two 2.5cm square surgical lint pands attached to "Sleek" plastic adhesive wrapping. The duration of the exposure was 24 hours. Skin examinations were conducted at 24, 72h after patch removal. The average scores produced by the group of 6 rabbits were 0.0 for erythema and 0.0 for oedema, giving a primary irritation score of 0.0. No reactions were observed throught the study.
The test substance is considered as non-irritating to the skin.
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