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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
Study period:
06 Sept 1999 - 10 Sept 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline study without deviations from guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): KLEMMFILZ ISOPHEN - 035 ( ISOPHEN - 035)
Yellow, solid substance - fibre
Lasting stability
Batch no: C 27.08.99 IV

Test animals

Species:
rabbit
Strain:
other: SPF albino rabbits
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Møllegaard Breeding and Reasearch Center A/S Ejby, DK-4623
- Age at study initiation: no data
- Weight at study initiation: 2,3-2,7 kg
- Housing: Individually in PPO cage. floor area: 2576 cm2
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: ad least one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: sesame oil
Controls:
no
Amount / concentration applied:
0.5 g of the fibre test article
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after termination of exposure
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm
- Type of wrap if used: 16-layer gauze patches


REMOVAL OF TEST SUBSTANCE
- Washing (if done): mild soap and luke warm 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
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within:
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within:
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible

Any other information on results incl. tables

 

Erythema formation observed at hours #

Individual mean scores*

Oedema formation observed at hours #

Individual mean scores*

 

Rabbit no

Weight kg

1

24

48

72

1

24

48

72

PL

1442

2.2

0

1

1

0

0.67

0

0

0

0

0.00

PR

0

0

0

0

0

0

0

0

PL

1349

2.3

0

0

0

0

0.00

0

0

0

0

0.00

PR

0

0

0

0

0

0

0

0

PL

1353

2.5

0

0

0

0

0.00

0

0

0

0

0.00

PR

0

0

0

0

0

0

0

0

PL: Posterior left test field

PR: Posterior right test field

# After termination of exposure

*Only the scores from the readings after 24, 48, and 72 hours are incuded in the calculation of the individual values.

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 as published in Council Directive 67/548/EEC and Regulation (EC) 1272/2008 the test samples examined are not irritating to rabbit skin in vivo. Thus, it is concluded that FMMVF fibres are not irritating to human skin.
Executive summary:

Three female albino rabbits were exposed to 0.5 g of the test material under a semi-occlusive bandage for 4 hours and subsequently monitored at the intervals of 1, 24, 48, 72 hours as well as 7 and 14 days after termination of exposure. The mean score for erythema was 0.67 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 MMVF fibres are not irritating to human skin.