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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:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted May 12, 1981
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
adopted September 19, 1984
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Laromer LR8869
- Physical state: yellowish liquid
- Analytical purity: 99.8
- Purity test date: 02/1992
- Lot/batch No.: 1/92
- Stability under test conditions: proven by reanalysis
- Storage condition of test material: refrigerator; exclusion of light

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler; D-W6050 Offenbach, FRG
- Age at study initiation: young adult
- Weight at study initiation: 3.18 - 3.59kg
- Housing: single in stainless steel cages with wire mesh floors (40x51cm)
- Diet (e.g. ad libitum): Kliba lab.diet 341 ad lib. (app. 130g / animal / day)
- Water (e.g. ad libitum): 250ml tap water / day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml / rabbit

Duration of treatment / exposure:
4h
Observation period:
8 days
observations: 1h after removal of dressing, 1, 2, 3, 8 days after application
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 X 2x5 cm
- Type of wrap if used: test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, D-W6750 Kaiserslautern) and Fixomull@ Stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of the exposure period, using Lutrol and Lutrol/water (1 : 1)
- Time after start of exposure:4h

SCORING SYSTEM: Draize, as described in OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean day 1-3
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: scaling observed on day 8
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean day 1-3
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: scaling observed on day 8
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean day 1-3
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
other: scaling observed on day 8
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
other: day 1-8
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:
Under the test conditions chosen and considering the described findings the test substance does not give indication of an irritant property to the skin.
Executive summary:

The potential of the test substance to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 ml to the intact skin of 3 White Vienna rabbits for 4 hours under semiocclusive dressing. The average score (24 to 72 hours) for irritation was calculated to be 0.9 for erythema and 0.0 for edema. The skin reactions were reversible within 8 days, thus the study was terminated.