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Toxicological information

Skin irritation / corrosion

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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:
2011
Report date:
2011

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

Constituent 1
Reference substance name:
Potassium aluminium silicate amorphous glass fibres
EC Number:
931-219-8
Molecular formula:
SinO(3n-1)2(n-1) polymeric anions ionically bonded to Al3+ and K2+ cations
IUPAC Name:
Potassium aluminium silicate amorphous glass fibres
Test material form:
solid: fibres
Details on test material:
- Name of test material (as cited in study report): Superwool 1400
- Substance type: Chopped fibrous wool
- Physical state: solid
- Analytical purity: >99%
- Stability under test conditions: stable
- Storage condition 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: Harlan UK Ltd., Biceseter
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: 2.1 - 2.5 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): ad libitum, Global Diet 2930C
- Water (e.g. ad libitum): ad libitum, mains drinking water
- Acclimation period: 7 to 14 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 elastic compression 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:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible within: 24 hrs
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible within: 24hrs
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritation or corrosive effects seen

Any other information on results incl. tables

Table1Individual dermal reactions

Dermal reaction

Observation Time

Individual Scores – Rabbit Number, Sex, Initial Body weight and Final Body Weight

Total

 

25M
(2.1 – 2.2 kg)

26M
(2.5 – 2.7 kg)

27M
(2.5 – 2.7 kg)

Erythema/Eschar Formation

Imm

0

N/A

N/A

N/A

 

1 Hour

0

0

0

(0)

 

24 Hours

0

0

0

0

 

48 Hours

0

0

0

(0)

 

72 Hours

0

0

0

0

 

Oedema Formation

Imm

0

N/A

N/A

N/A

 

1 Hour

0

0

0

(0)

 

24 Hours

0

0

0

0

 

48 Hours

0

0

0

(0)

 

72 Hours

0

0

0

0

 

Sum of 24 and 72 hour Readings (S)

:

0

 

Primary Irritation Index (S/6)

:

0/6 = 0

 

Classification

:

NON-IRRITANT

 

 

( ) = total values not used for calculation of primary irritation index
N/A = not applicable

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.