Registration Dossier
Registration Dossier
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EC number: 614-074-2 | CAS number: 675106-31-7
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:
- guideline 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:
- 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
Constituent 1
- Specific details on test material used for the study:
- Name of test material as cited in the study report: Superwool B3 ;
Substance type: chopped fibrous wool
Physical state : solid
Analytical purity : >99.9%
Stability under test conditions: stable
Storage of test material: dry sealed container
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:2.34-2.53 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:
- Test site
areas of exposure:dorsal flank
% coverage:
type of wrap: 2.5cm square guaze patch secured using surgical adhesive tape.
Removal of the test substance:
Any residual test material removed by gentle swabbing with cotton wool soaked in dostilled water.
time after start of the exposure: 4 hours
scorring: Draize system
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 hour
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24hrs
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 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:
- 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:
- 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:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- 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 corrosive effects observed
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:
- GHS criteria not met
- 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 skin. No corrosive effects were observed.
- Executive summary:
As the test material did not produce postive criteria for irritation or corrosiveness, in any rabbit according to the EEC labelling regualtions it 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 irritatncy classification previously required has been with drawn.
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