Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD Guideline 404 and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute 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): Ethansalz 97/100
- Synonyms: Oxethansulfonsaures Natrium
- Substance type: solid
- Physical state: white powder
- Analytical purity: >= 97 %
- Lot/batch No.: Op. 36
- Production date: 21.05.1986
- Storage condition of test material: darkness at approx. 22 °C in a fume cupboard
- melting point: 160-180 °C
- pH in water : 11-11,5

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breed
- Age at study initiation: about 3 -5 months
- Weight at study initiation: 2.6 - 2.8 kg
- Housing: in fully air-conditioned rooms, separate cages (arranged in a battery)
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): deionised, chlorinated water from automatic water dispenser, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3 °C
- Humidity (%): 50 +-20 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL isotonic saline
Duration of treatment / exposure:
4 hrs
Then test substance was removed from the skin with warm tap water
Observation period:
30 - 60 min. after removal of the patches
24, 48 and 72 hrs after removal of the patches
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100 %
The moistened substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf AG, Hamburg). The plaster was fixed to the prepared skinarea (ca. 25 cm2) and then covered with a semi-occlusive bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm tap water
- Time after start of exposure: 4 hrs


SCORING SYSTEM:

Erythema and eschar formation
No erythema.......................................................................................................................0
very slight erythema (barely perceptible)......................................................................1
well-defined erythema......................................................................................................2
moderate to severe erythema..........................................................................................3
severe erythema (beet redness) to slight eschar formation (lesion in depth).........4

Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
4

Any other information on results incl. tables

Time after removal of the patch 30 - 60 24 h 48 h 72 h
min
Animal no. 1 2 3 1 2 3 1 2 3 1 2 3
Erythema and eschar formation 0 0 0 0 0 0 0 0 0 0 0 0
Oedema formation 0 0 0 0 0 0 0 0 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:
Classification: not irritating
Executive summary:

Skin irritation was tested in a guideline study according to OECD guideline 404 in rabbits. 24 hours up to three days after treatment, the skin did not show any sign of erythema or edema. Mean scores on all observation time points after application were 0 for the three animals.

The test substance was classified as not irritating.