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

Skin irritation / corrosion

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

Test material information

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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 hour

Score:

0

Max. score:

0

Remarks on result:

other: Sample A

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

other: Sample A

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

other: Sample A

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

other: Sample A

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 hour

Score:

0

Max. score:

0

Remarks on result:

other: Sample A

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

other: Sample A

Results 7

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

other: Sample A

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

other: Sample A

Results 9

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 hour

Score:

0

Max. score:

0

Remarks on result:

other: Sample B

Results 10

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

Results 11

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

other: Sample B

Results 12

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.