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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:
1997 - 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted in accordance with GLP. However, in case of the test substance the date of storage stability was crossed as the study was performed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
Please refer to the section "confidential details on test material" below.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr . K . THOMAE GmbH, Biberach, Germany
- Age at study initiation: Young adult animals
- Weight at study initiation: Animal 1: 3.74 kg (female); Animal 2: 3.41 kg (male); Animal 3: 3.66 kg (male)
- 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: Kliba-Labordiät, Klingentalmühle AG, Kaiseraugst, Switzerland (about 130 g per day)
- Water: about 250 mL tap water per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70 %
- Air changes: Fully air-conditioned rooms
- Photoperiod: 12 hrs dark / 12 hrs light (6 .00 a .m . - 6 .00 p .m ./6 .00 p .m . - 6 .00 a .m . )

IN-LIFE DATES: From: 1997-01-20 To: 1997-02-03

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin sites of the same animal.
Amount / concentration applied:
undiluted
TEST MATERIAL
- Amount(s) applied: 0.5 mL (undiluted)
Duration of treatment / exposure:
4 hour(s)
Observation period:
15 days
Number of animals:
3 rabbits
Details on study design:
TEST SITE: Third of the back or flanks
- Area of exposure: 6.25 cm²
- % coverage: 0.42
- Type of wrap if used: Adhesive fleece

REMOVAL OF TEST SUBSTANCE
- Washing: Lutrol(R) and Lutrol(R)/water (1 :1); Lutrol: Polyethylenglycol
- Time after start of exposure: at the end of the exposure period

SCORING SYSTEM: Draize scale of scoring

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: 1, 24, 48, 72 h and 8, 15 d
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Time point:
other: 1, 24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: Erythema extending beyond the area of exposure
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 48, 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: Erythema extending beyond the area of exposure
Irritation parameter:
erythema score
Basis:
animal: #2, #3
Time point:
other: 48, 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: Erythema extending beyond the area of exposure
Irritation parameter:
erythema score
Basis:
animal: #1, #3
Time point:
other: 8, 15 d
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 15 d
Remarks on result:
other: Scaling, erythema extending beyond the area of exposure, scaling extending beyond the area of exposure
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 8, 15 d
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h (mean)
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h (mean)
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h (mean)
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 h (mean)
Score:
0
Max. score:
4

Any other information on results incl. tables

Erythema remained over 15 days in two animals and extended beyond the application site; scaling was also still visible after 15 days and also extending beyond the application site.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU