Registration Dossier
Registration Dossier
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EC number: 266-046-0 | CAS number: 65997-17-3 This category encompasses the various chemical substances manufactured in the production of inorganic glasses. For purposes of this category, 'glass' is defined as an amorfous, inorganic, transparent, translucent or opaque material traditionally formed by fusion of sources of silica with a flux, such as an alkali-metal carbonate, boron oxide, etc. and a stabilizer, into a mass which is cooled to a rigid condition without crystallization in the case of transparent or liquid-phase separated glass or with controlled crystallization in the case of glass-ceramics. The category consists of the various chemical substances, other than by-products or impurities, which are formed during the production of various glasses and concurrently incorporated into a glass mixture. All glasses contain one or more of these substances, but few, if any, contain all of them. The elements listed below are principally present as components of oxide systems but some may also be present as halides or chalcogenides, in multiple oxidation states, or in more complex compounds. Trace amounts of other oxides or chemical compounds may be present. Oxides of the first seven elements listed* comprise more than 95 percent, by weight, of the glass produced. @Aluminium*@Lead@Boron*@Lithium@Calcium*@Manganese@Magnesium*@Molybdenum@Potassium*@Neodymium@Silicon*@Nickel@Sodium*@Niobium@Antimony@Nitrogen@Arsenic@Phosphorus@Barium@Praseodymium@Bismuth@Rubidium@Cadmium@Selenium@Carbon@Silver@Cerium@Strontium@Cesium@Sulfur@Chromium@Tellurium@Cobalt@Tin@Copper@Titanium@Germanium@Tungsten@Gold@Uranium@Holmium@Vanadium@Iron@Zinc@Lanthanum@Zirconium
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 Oct. 1999 - 26 Oct. 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study without deviations from guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- MMVF note Q fibres
- IUPAC Name:
- MMVF note Q fibres
- Details on test material:
- - Name of test material (as cited in study report): STEINWOLLFASERN A-SCFS
Brown, solid substance - fibre
Lasting stability
Batch no: gesiebt, perlenfrei, ohne Bindemittel
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: SPF albino rabbits
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Møllegaard Breeding and Reasearch Center A/S Ejby, DK-4623
- Age at study initiation: no data
- Weight at study initiation: 2,3-2,7 kg
- Housing: Individually in PPO cage. floor area: 2576 cm2
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: ad least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: sesame oil
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of the fibre test article
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm
- Type of wrap if used: 16-layer gauze patches
REMOVAL OF TEST SUBSTANCE
- Washing (if done): mild soap and luke warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Erythema and Escar formation scale:
no erythema: 0
Very light eryhema (barely perceptible): 1
well-defined erythema: 2
Moderate erythema: 3
Severe erythema:4
Oedema formation scale:
no oedema: 0
Very light oedema (barely perceptible): 1
well-defined oedema: 2 (edges of area well-defined by definite raising)
Moderate erythema: 3 (raised approx. 1 mm)
Severe erythema:4 (raised more than 1 mm, extending beyond area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
Any other information on results incl. tables
|
Erythema formation observed at hours # |
Individual mean scores* |
Oedema formation observed at hours # |
Individual mean scores* |
||||||||
|
Rabbit no |
Weight kg |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
||
PL |
1359 |
2.7 |
0 |
1 |
1 |
1 |
1.00 |
0 |
0 |
0 |
0 |
0.00 |
PR |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
||||
PL |
1367 |
2.4 |
0 |
1 |
1 |
1 |
1.00 |
0 |
0 |
0 |
0 |
0.00 |
PR |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
||||
PL |
1397 |
2.3 |
0 |
1 |
1 |
1 |
1.00 |
0 |
0 |
0 |
0 |
0.00 |
PR |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
||||
PL: Posterior left test field
PR: Posterior right test field
# After termination of exposure
*Only the scores from the readings after 24, 48, and 72 hours are incuded in the calculation of the individual values.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- It is evaluated based on the presented data that E-glass microfibre is not irritating to rabbit skin in vivo. It is thus concluded according to the EC-standards as published in Council Directive 67/548/EEC and Regulation (EC) 1272/2008 that E-glass microfibre is not skin irritant.
- Executive summary:
Three female albino rabbits were exposed to 0.5 g of the test material under a semi-occlusive bandage for 4 hours and subsequently monitored at the intervals of 1, 24, 48, 72 hours as well as 7 and 14 days after termination of exposure. The mean score for erythema was 1 and mean score for oedema was 0.
It is concluded that E-glass fibre is not irritating to human skin.
Hence, E-glass microfibre shall not be classified as skin irritating according to Council Directive 67/548/EEC and Regulation (EC) 1272/2008.
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