Registration Dossier
Registration Dossier
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EC number: 610-130-5 | CAS number: 436083-99-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- amporphous glass fibre formed from the melting and fiberisation of predominately slilcon dioxide, calcium oxide, magnesium oxide
- EC Number:
- 610-130-5
- Cas Number:
- 436083-99-7
- Molecular formula:
- Amorphous glass consisting of SinO(3n-1)2(n-1) Polymeric anions ionically bonded to Ca2+ and Mg2+ cations or other alkaline earth cations
- IUPAC Name:
- amporphous glass fibre formed from the melting and fiberisation of predominately slilcon dioxide, calcium oxide, magnesium oxide
- Details on test material:
- - Name of test material (as cited in study report): Superwool B3
- Substance type: Chopped fibrous wool
- Physical state: solid
- Analytical purity: >99%
- Stability under test conditions: stable
- Storage condition of test material: dry sealed container
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 - 16 weeks
- Weight at study initiation: 2.34 - 2.53kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): ad libitum, Spillers Rabbit Diet
- Water (e.g. ad libitum): ad libitum, mains drinking water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 52 - 57
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hour cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g/rabbit - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal flank area
- % coverage:
- Type of wrap if used: 2.5cm square gauze patch, secured using surgical adhesive tape,
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize System
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1hr
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hrs
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- 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
- Reversibility:
- fully reversible
- 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
- Reversibility:
- fully reversible
- 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
- Reversibility:
- not specified
- 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
- Reversibility:
- not specified
- 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
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation or corrosive effects seen
Any other information on results incl. tables
Table 1: Superwool B3: acute dermal irritation test in the rabbit, individual skin reactions
skin reaction |
observation time (hours) |
individual scores - rabbit number and sex (bodyweight kg) |
|||
167 male (2.34) |
169 male (2.46) |
169 female (2.53) |
total |
||
Erythema/eschar formation |
1 |
1 |
0 |
1 |
(2) |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
(0) |
|
72 |
0 |
0 |
0 |
0 |
|
odema formation |
1 |
0 |
0 |
0 |
(0) |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
(0) |
|
72 |
0 |
0 |
0 |
0 |
|
Sum of 24 and 72- hour readings : 0
Primary Irritation Index (s/6) : 0/6 = 0.0
Classification : Non-irritant
( ) = total values not used for calculation of primary irritation index
Table 2: Superwool B3: acute dermal irritation test in the rabbit, individual daily and individual mean scores for dermal irritation following 4-hour exposure required for EEC labelling regulations.
skin reaction |
reading (hours) |
individual scores -rabbit number and sex (body weight) |
||
167 male (2.34) |
169 male (2.46) |
196 female (2.53) |
||
erythema/eschar formation |
24 |
0 |
0 |
0 |
48 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
|
total |
0 |
0 |
0 |
|
mean score |
0 |
0 |
0 |
|
oedema formation |
24 |
0 |
0 |
0 |
48 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
|
total |
0 |
0 |
0 |
|
mean score |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance produced a primary skin irritation index of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
- Executive summary:
As the test material did not produce positive criteria for irritation or corrosiveness in any rabbit according to the EEC labelling regulations and was classified as non-irritant to rabbit skin. No symbol or risk phrases are therefore required. This has been confirmed in ATP 1 of the CLP regulations where the irritancy classification previously required has been withdrawn.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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