Registration Dossier

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994
Reference Type:
other: Amendment
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of the test substance used in the study report: Asta-C6-Acetal
- Physical state: liquid, achromatic
- Storage: refrigerator, exclusion of light

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, FRG
- Age at study initiation: young adults
- Weight at study initiation: 3.26 - 3.66 kg
- Housing: single housing, stainless steel wire mesh cages with grating, floor area 3000 cm2; no bedding in the cages, sawdust in the waste trays
- Diet: 130 g/day, Kliba-Labordiaet 341, Klingentalmuehle AG Kaiseraugst, Switzerland
- Water: 250 mL/day tap water
- Acclimation period: at least 1 week

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
The test patches (2.5 x 2.5 cm) were moistened with a dose of 0.5 mL of the undiluted liquid test substance.
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm, upper third of the back or flanks
- Type of wrap if used: test patch (idealbinde, pfaelzische verbandstoff-fabrik, Kaiserslautern) and Fixomull stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing: lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 h

SCORING SYSTEM: erythema and eschar formation, and edema formation according to OECD 404 guideline 1, 24, 48, and 72 hours after removal of the patch.

General observations: A check was made twice each workday and once on saturdays, sundays and on public holidays for general observations and for any dead or moribund animals.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Under the conditions of the test the substance is considered to be not corrosive or irritating to the skin.
Executive summary:

The potential to cause acute dermal irritation or corrosion was assessed in a OECD 404 guideline study (in compliance with GLP) by a single topical application of 0.5 mL of the test substance 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 0.1 for erythema and 0.0 for edema. The findings were reversible between 24 and 48 hours after removal of the patches. It was concluded that the test substance was not irritating to the skin.