Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline study without deviations from guideline.
Remarks:
FMMVF ( although not exonerated with note Q) are of the same morphology and composition as the wider MMVF and the test samples used here

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Man-made vitreous (silicate) fibres with random orientation with alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content greater than 18% by weight
IUPAC Name:
Man-made vitreous (silicate) fibres with random orientation with alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content greater than 18% by weight
Constituent 2
Reference substance name:
Rockwool
IUPAC Name:
Rockwool
Constituent 3
Reference substance name:
Stone wool
IUPAC Name:
Stone wool
Details on test material:
Sample A: yellowish block of Rockwool
Sample B: brownish block of Rockwool
Stored at ambient temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:Centre Lagro, France
- Age at study initiation: Females young adult
- Weight at study initiation: 2,110-2,358 kg
- Housing: Individually in stainless steel cages with perforated floor
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 44-99
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
-Ventilation: ca. 10 air changes/hour

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
A 2.5x 2.5 cm piece of each sample A and B respectively was mounted on a gauze pad and moistoned with 2 ml water before application to test site.
( This is expected to weigh <0.5g - as this is a fibre matrix a patch was cut to the appropriate size))
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm
- Type of wrap if used: gauze patches


REMOVAL OF TEST SUBSTANCE
- Washing (if done): 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
Remarks on result:
other: Sample A
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Sample A
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Sample A
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Sample A
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
0
Remarks on result:
other: Sample A
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Sample A
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Sample A
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Sample A
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
0
Remarks on result:
other: Sample B
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Sample B
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Sample B
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Sample B

Any other information on results incl. tables

Skin irritation scores of Rockwool sample A and Rockwool sample B, after a single 4 -hour dermal exposure:

Hours after removal of sample A

Animal no.

1

24

48

72

E-O

E-O

E-O

E-O

67

0 -0

0 -0

0 -0

0 -0

69

0 -0

0 -0

0 -0

0 -0

71

0 -0

0 -0

0 -0

0 -0

Hours after removal of sample B

Animal no.

1

24

48

72

E-O

E-O

E-O

E-O

67

0 -0 *

1 -0

0 -0

0 -0

69

0 -0

0 -0

0 -0

0 -0

71

0 -0

0 -0

0 -0

0 -0

E = erythema (including ischemia, heamorrhages and incrustation); O = oedema.

* abrasion marks

Mean values for erythema and oedema of each rabbit scored at 24, 48, and 72 hours after treatment with Rockwool sample A and Rockwool sample B

Sample A

Animal no.

Erythema

Oedema

67

0.0

0.0

69

0.0

0.0

71

0.0

0.0

Sample B

Animal no.

Erythema

Oedema

67

0.3

0.0

69

0.0

0.0

71

0.0

0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the EC-standards Regulation (EC) 1272/2008 the test samples examined are not irritating to rabbit skin in vivo. Thus, it is concluded that as those fibres considered as FMMVF ( not exonerated with note Q) are of the same morphology and composition as the wider MMVF used here and as such are not irritating to human skin.
Executive summary:

3 New Zealand Albino rabbits were exposed to 2.5x2.5 cm of the test material under a semi-occlusive bandage for 4 hours and subsequently monitored at the intervals 1, 24, 48, 72 hours and after 7 and 14 days. The mean score for erythema was 1 and mean score for oedema was 0. Hence, the material shall not be classified as skin irritating according to Council Directive 67/548/EEC and Regulation (EC) 1272/2008 . It is concluded that FMMVF fibres are not irritating to human skin.