Registration Dossier
Registration Dossier
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EC number: 604-314-4 | CAS number: 142844-00-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Remarks:
- Negative results in skin irritation studies in animals and no positive results in humans result in non classification for irritancy and corrosion.In accordance with 31st Adaptation to Technical Progress (ATP) of Directive 67/548/ECC
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study
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:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 142844-00-06
- IUPAC Name:
- 142844-00-06
- Reference substance name:
- oxo[(oxoalumanyl)oxy]alumane; silanedione
- EC Number:
- 604-314-4
- Cas Number:
- 142844-00-6
- Molecular formula:
- amorphous glass Si(n)O(3n+1) polymeric anions bonded to Zr and Al(3+)
- IUPAC Name:
- oxo[(oxoalumanyl)oxy]alumane; silanedione
- Details on test material:
- Chopped bulk refractory ceramic fibre(RCF)
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Chopped fibre in water
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival limited Moston Sandbach Cheshire
- Age at study initiation:12-16 weeks
- Weight at study initiation:234-253 kg
- Housing: Individually housed in suspended metal cages
- Diet (e.g. ad libitum):Spillers rabbit diet
- Water (e.g. ad libitum):mains drinking water
- Acclimation period:5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):18-22
- Humidity (%):52-57
- Air changes (per hr):approx 15
- Photoperiod (hrs dark / hrs light):12hour cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5g/rabbit
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- Chopped fibre applied on to the shorn skin and held in place with a semi occlusive dressing. The site examined at 1,24,48,72 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- ca. 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- no irritation or corrosion observed
- Other effects:
- none
Any other information on results incl. tables
Table 1 - RCF : Acute Dermal irritation test in rabbit - individual daily and individual mean scores for dermal irritation following 4 hour exposure
Skin Reaction |
Reading (hours) |
Individual scores – rabbit number and sex (body weight kg) |
||
191 female (2.28) |
199 male (2.46) |
201 male (2.89) |
||
Erythema/Eschar formation |
24 48 72 |
0 0 0 |
1 0 0 |
0 0 0 |
Total |
|
0 |
1 |
0 |
Mean Score |
|
0.0 |
0.3 |
0.0 |
Oedema formation |
24 48 72 |
0 0 0 |
0 0 0 |
0 0 0 |
Total |
|
0 |
0 |
0 |
Mean Score |
|
0.0 |
0.0 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Remarks:
- Negative results in skin irritation studies in animals and no positive results in humans result in non classification for irritancy and corrosion.In accordance with 31st Adaptation to Technical Progress (ATP) of Directive 67/548/ECC
- Conclusions:
- The test article could not be classified as irritant
- Executive summary:
There is no reason to classify this material as irritant nor corrosive.
This was confirmed with 31st Adaptation to Technical Progress (ATP) of Directive 67/548/ECC as published 15th January 2009 as the classification as “irritant” was removed for all types of man made vitreous fibres (MMVFs). .
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