Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

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:
- Physical state / appearance: liquid / colourless, clear
- Substance number: 96/184
- Batch number: Vers. 130/U
- Analytical purity: 99.4%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Supplier: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: young adult female
- Weight at study initiation: 4.00 kg
- Housing: stainless steel wire mesh cages with grating, floor area 3000 cm2; single housing; no bedding in the cages, sawdust in the waste trays
- Diet: ca. 130 g KLIBA-labordiaet 341 (Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland) per animal per day
- Water: 250 ml tap water per animal per day
- Acclimation period: at least one week

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: the fur was removed by clipping
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied): 0.5 ml
Duration of treatment / exposure:
3 min and 1 h
Observation period:
1 and 24 h
Number of animals:
1
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: idealbinde, Pfälzische Verbandtstoff-Fabrik, Kaiserslautern) and Fixomull® strech (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol® E 400 (Polyethylene glycol DAB, BASF AG) and Lutrol®:water (1:1)
- Time after start of exposure: 3 min and 1 h

SCORING SYSTEM: acccording to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
3 min of exposure
Basis:
animal #1
Time point:
other: 1 h
Score:
2
Max. score:
4
Remarks on result:
other: necrosis, index for erythema of the surrounding area
Irritation parameter:
erythema score
Remarks:
3 min of exposure
Basis:
animal #1
Time point:
other: 24 h
Score:
3
Max. score:
4
Remarks on result:
other: necrosis, index for erythema of the surrounding area, study discontinued because of severe irritation
Irritation parameter:
erythema score
Remarks:
1 h of exposure
Basis:
animal #1
Time point:
other: 1 h
Score:
2
Max. score:
4
Remarks on result:
other: necrosis, index for erythema of the surrounding area
Irritation parameter:
erythema score
Remarks:
1 h of exposure
Basis:
animal #1
Time point:
other: 24 h
Score:
3
Max. score:
4
Remarks on result:
other: necrosis, index for erythema of the surrounding area, study discontinued because of severe irritation
Irritation parameter:
edema score
Remarks:
3 min of exposure
Basis:
animal #1
Time point:
other: 1 h
Score:
2
Max. score:
4
Remarks on result:
other: necrosis, edema extending beyond the area of exposure
Irritation parameter:
edema score
Remarks:
3 min of exposure
Basis:
animal #1
Time point:
other: 24 h
Score:
2
Max. score:
4
Remarks on result:
other: necrosis, edema extening beyond the area of exposure, study discontinued because of severe irritation
Irritation parameter:
edema score
Remarks:
1 h of exposure
Basis:
animal #1
Time point:
other: 1 h
Score:
2
Max. score:
4
Remarks on result:
other: necrosis, edema extending beyond the area of exposure
Irritation parameter:
edema score
Remarks:
1 h of exposure
Basis:
animal #1
Time point:
other: 24 h
Score:
3
Max. score:
4
Remarks on result:
other: necrosis, edema extending beyond the area of exposure, study discontinued because of severe irritation
Irritant / corrosive response data:
Full thickness necrosis (assessed by histopathological examination) was observed at all exposure durations and erythema and edema were observed beyond the area of exposure. The study was discontinued because of severe skin irritation.

Applicant's summary and conclusion

Interpretation of results:
highly corrosive
Remarks:
Migrated information