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other: GLP compliant guideline study, available as unpublished report.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 test material (as cited in study report): Asta-C9-Diol-Natrium
- Physical state/appearance: Liquid, red-brown
- Storage conditions: 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 adult animals
- Weight at study initiation: 2.70 - 2.98 kg
- Housing: Single housing in stainless steel wire mesh cages with grating. Floor area: 3000 cm2. No bedding in the cages.
- Diet: Kliba-Labordiaet 343, Klingentalmuehle AG, Kaiseraugst, Switzerland. About 130 g per animal per day
- Water: Tap water, about 250 mL per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): Fully airconditioned rooms
- Photoperiod (hrs dark / hrs light): 12 / 12 ( 6.00 a.m. - 6.00p.m. / 6.00 p.m. - 6.00 a.m.)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
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 0.5 mL of the unchanged liquid test substance
Duration of treatment / exposure:
4 hour
Observation period:
72 hour
Number of animals:
3 (1 male and 2 female animals)
Details on study design:
- Application site: upper third of the back or flanks
- Readings: 1 h, 24 h, 48 h and 72 h after removal of the test patches
- A check for general observations and mortality was made twice each working day and once on weekends and on public holidays

REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hour

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1-3
Time point:
other: mean 24-48-72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: 1-3
Time point:
other: mean 24-48-72 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 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 semi-occlusive dressing. The cutaneous reactions were assessed immediately after removal of the patch and approximately 24, 48, 72 hours after removal. No skin reaction could be observed at any time point; thus the study was terminated 72 hours after removal of the dressings. It was concluded that the test substance was not irritating to the skin.